學術產出-Theses
Article View/Open
Publication Export
-
題名 大藥廠之藥品生命週期管理策略—以威而鋼®、犀利士®與樂威壯®為例
Drug life cycle management strategies for big pharma - The case studies on Viagra®, Cialis® and Levitra®作者 張恭銘
Chang, Kung-Ming貢獻者 陳桂恒
Chan, Keith
張恭銘
Chang, Kung-Ming關鍵詞 藥品
生命週期管理策略
大藥廠
威而鋼®
犀利士®
樂威壯®
Drug
Life cycle management strategy
Big pharma
Viagra®
Cialis®
Levitra®日期 2017 上傳時間 10-Aug-2018 11:05:02 (UTC+8) 摘要 藥品生命週期管理策略是透過一連串經創新與制度的應用來延長藥品生命週期，並將獲利極大化的作為。近年來，由於大藥廠之研發能量不足等困境，藥品生命週期管理之議題更加受到重視，其應用的策略亦相當豐富與多樣，相當值得開始有新藥成果的台灣廠商參考與學習。本研究以輝瑞—威而鋼®、禮來—犀利士®以及拜耳—樂威壯®作為研究對象，並將藥品生命週期管理策略分為研究開發、商業化、智財法規等三大策略構面，藉由回顧性個案分析法以及案例比較分析法，了解個案公司在藥品生命週期管理議題之策略運用、時機選擇及互動關係，從中歸納出結論並提供台灣藥廠對應之建議。本研究發現，威而鋼®透過積極的藥品生命週期管理策略之佈局與運用，大大延續了藥物之競爭力與獲利，包含擴張新適應症、建構產品家族、善用商業外觀、創造連續的專屬權等等。犀利士®亦透過積極投入藥品生命週期管理，包含新劑型、新適應症、差異化的推廣策略、創造連續的專屬權…等方式，最終擊敗威而鋼®成為市場的領頭羊。反觀樂威壯®則較為不作為，使得營收與其他兩名競爭者有顯著差距。透過本研究歸納之發現與結論，可得知藥品生命週期管理是一門搶時間的學問；藥廠對於藥品生命週期管理策略的積極與消極作為對藥物之營收表現有顯著影響；藥品生命週期管理策略亦有風險；藥品生命週期不僅為跨部門跨領域之議題，更可透過合作來創造優勢…等。期許本研究能嘗試補足台灣關於藥品生命週期管理策略之研究領域，同時促進國內生技產業界對該領域之重視。
Drug life cycle management (LCM) strategy is a way to maximize revenue and the lifespan of a drug compound. With the increasing costs and time on the R&D processes and many other reasons, LCM becomes a significant topic for the pharmaceutical companies.The key LCM strategies can be categorized into development, commercial and IP/regulatory scopes. This thesis focuses on the top 3 PDE5 inhibitor class drugs, Viagra®, Cialis® and Levitra®, trying to illustrate the different options and strategies in their drug LCM through retrospective study and case analysis method.This thesis indicates that Viagra® performed the best in its LCM via combining multiple strategies at the right timing, inclusive of new indication expansion, family of products establishment, trade dress protection, etc. And Cialis®, the third-in-class drug in the PDE5i class, competed with Viagra® by aggressively applying various LCM strategies, including new formulation, new indication expansion, promotion differentiation and sequential exclusivities. In contrast, Levitra® was a relatively passive player in the game. As the result, Viagra® ranked the top in erectile dysfunction market for many years. While® Cialis pursued closely and beat Viagra® in the end. Levitra®, without a doubt, earned far less than the other two drugs.This thesis shows that the drug LCM is a cross-functional task, and the strategies are extremely rich and varied. A successful LCM needs lots of preparations and investments in order to earn more time and to differentiate from the competitors.參考文獻 中文部分書籍克萊頓．克里斯坦森、杰羅姆．格羅斯曼、黃傑升 著，朱恒鵬、張琦 譯（2015）。創新者的處方：顛覆式創新如何改變醫療。一版。北京：中國人民大學出版社。羅淑慧、陳麗敏（2010）。藥品再創價值的策略運用與發展趨勢。經濟部技術處委託財團法人生物技術開發中心之專題研究成果報告。台北市：經濟部ITIS專案辦公室。期刊陳翠華（2008）。我國醫藥品專利權期間延長制度之探討(上)。智慧財產權月刊，114期。台北：經濟部智慧財產局。研究計畫馮震宇、丘耀華、盧憶、陳香羽（2012）。逆向付款(Reverse Payment)之法律爭議與政策研究研究成果報告（精簡版）。行政院國家科學委員會專題研究計畫。未出版。取自：https://nccur.lib.nccu.edu.tw/bitstream/140.119/55949/1/100-2410-H004-021.pdf，最後瀏覽日：2017/4/12。經濟部智慧財產局（2014）。美國專利連結與橘皮書登錄制度研究。經濟部智慧財產局委託理律法律事務所之專題研究成果報告（編號：019104155-1）。未出版。取自：https://www.tipo.gov.tw/public/Attachment/511916312153.pdf，最後瀏覽日：2017/4/12。碩博士學位論文吳東哲（2015）。藥品的核准前專利爭端解決程序—以美國專利連結為借鏡，國立政治大學法律科際整合研究所碩士論文。取自臺灣博碩士論文系統。吳東霖（2004）。治療男性勃起功能障礙藥物在台灣市場競爭策略之探討，國立中山大學管理學院高階經營碩士學程在職專班碩士論文。取自臺灣博碩士論文系統。吳豐江（2015）。美國藥物專利布局與其相應之研究開發與法規活動—以諾華藥廠之 Gleevec®為例，國立政治大學科技管理與智慧財產研究所碩士論文。取自臺灣博碩士論文系統。網際網路中華民國衛生福利部 – 衛部藥輸字第026295號 。取自：http://www.fda.gov.tw/MLMS/H0001D.aspx?Type=Lic&LicId=52026295，最後瀏覽日：2017/5/30科技產業資訊室。關於專利家族（patent family）。取自：http://cdnet.stpi.narl.org.tw/techroom/pclass/pclass006.htm，最後瀏覽日：2017/5/30。葉雲卿（2015）。淺談醫藥專利典型權利請求項。北美智權報。取自：http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Biotechnology/publish-18.htm，最後瀏覽日：2017/4/11。其他李世仁博士（2016）。《Crossing the Chasm: From Bench to Business》投影片，生技醫藥產學合作交流研討會。台北市：台灣研發型生技新藥發展協會。陳桂恒博士（2016）。生技商業化：科學、法規、法律與商業化基本功—新藥、類新藥、學名藥藥品批准。國立政治大學科技管理與智慧財產研究所課程講義。勤業眾信趨勢分析報告（2016）。生技醫療產業展望報告。取自：https://www2.deloitte.com/content/dam/Deloitte/tw/Documents/life-sciences-health-care/tw-2016lshc-outlook.pdf，最後瀏覽日：2017/3/24.英文部分書籍David Jobber and John Fahy (2003). Foundations of Marketing. Berkshire, England: Mcgraw-Hill Education.Donald Kirsch (2014). Therapeutic Drug Development and Human Clinical Trials. In Craig Shimasaki, et al. (Eds.). Biotechnology Entrepreneurship. Massachusetts, MA: Elsevier Inc.Jay Baglia (2005). The Viagra Ad Venture: Masculinity, Media, and the Performance of Sexual Health. New York, NY: Peter Lang Publishing Inc.Kappe Eelco (2014). Pharmaceutical Life Cycle Extension Strategies. In Min Ding, Jehoshua Eliashberg, and Stefan Stremersh, et al. (Eds.). Innovation and Marketing in the Pharmaceutical Industry. Philadelphia, PA: Springer Science + Business Media.Tony Ellery and Neal Hansen (2012). Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand. New Jersey, NJ: A John Wiley & Sons, Inc., Publication.期刊Asher Mullard (2017). 2016 FDA Drug Approvals. Nature Reviews Drug Discovery, Vol. 16, Feb. 2017, pp. 73-76.David Cavalla (2003). The Extended Pharmaceutical Enterprise. Drug Discovery Today, Vol. 8, No. 6, Mar. 2003, pp. 267-274.Henry Feldman, et al. Impotence and Its Medical and Psychosocial Correlates, Massachusetts Male Aging Study. The Journal of Urology, Vol. 151, Jan. 1994, pp. 54-61.Hossein Ghofrani, Ian Osterloh and Friedrich Grimminger (2006). Sildenafil: from Angina to Erectile Dysfunction to Pulmonary Hypertension and Beyond. Nature Review Drug Discovery, Vol. 5, Aug. 2006, pp. 689-702.James Conley, Peter Bican and Holger Ernst (2013). Value Articulation: A Framework for the Strategic Management of Intellectual Property. California Management Review, Vol. 55, No. 4, pp. 102-120.Jeremy Greene and and Aaron Kesselheim (2011). Why Do the Same Drugs Look Different? Pills, Trade Dress, and Public Health. The New England Journal of Medicine, Vol. 365, Jul. 2011, pp. 83-89.Katherine Neumeyer and Peter Kirkpatrick (2004). Fresh from the Pipeline: Tadalafil and vardenafil. Nature Reviews Drug Discovery, Vol. 3, Apr. 2004, pp. 295-296.Laura Mahecha (2006). Rx-to-OTC Switches: Trends and Factors Underlying Success. Nature Reviews Drug Discovery, Vol. 5, May. 2006, pp. 380-386.Mannching Sherry Ku (2015). Recent Trends in Specialty Pharma Business Model, Journal of Food and Drug Analysis, Vol. 23, Dec. 2015, p. 595-608.María José Abud, Bronwyn Hall and Christian Helmers (2015). An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile. PLoS ONE. Vol. 10, Apr. 2015, pp. 1-17.Maria Kubin, Gorm Wagner and Alex Fugl-Meyer (2003). Epidemiology of Erectile Dysfunction. International Journal of Impotence Research, Vol. 15, Feb. 2003, pp. 63-71.Myoung Cha, Abhishek Saxena, Katarzyna Smietana & Roerich Bansal (2015). Deal watch: Panning for gold: sourcing pharmaceutical innovation. Nature Reviews Drug Discovery, Vol. 14, May. 2015, p. 376.Peter Sandner and Karl Ziegelbauer (2008). Product-related Research: How Research Can Contribute to Successful Life-Cycle Management. Drug Discovery Today, Vol. 13, No. 9/10, May. 2008, pp. 457-463.Raymond Vernon (1966). International Investment and International Trade in the Product Cycle. The Quarterly Journal of Economics, Vol. 80, No. 2, May. 1966, pp. 190-207. Source: http://www.sba.muohio.edu/dunlevja/Course%20Links/EC441/Vernon.pdf, last visited: 2017/4/3.Sharon Huang and Janette Lie (2013). Phosphodiesterase-5 (PDE5) Inhibitors in the Management of Erectile Dysfunction. Pharmacy and Therapeutics, Vol. 38, No. 7, Jul. 2013, pp. 414-419.Shraddha Chowdhary (2015). A Study of Product Life Cycle Extension Strategies of Patented Drugs to Deter Entry of Generics. International Journal of Pharmaceutical Science and Health Care, Vol. 3, No. 5, May. - Jun. 2015, pp. 99-108.Ventola Lee (2011). Direct-to-Consumer Pharmaceutical Advertising. Pharmacy and Therapeutics, Vol. 36, No. 10, Oct. 2011, pp. 669-674, 681-684.分析報告Antonio Iervolino, et al. (2016). EvaluatePharma, task force. World Preview 2016, Outlook to 2022. Source: http://info.evaluategroup.com/rs/607-YGS-364/images/wp16.pdf , last visited: 2017/3/24.Arthur D. Little (2016), task force. Trends in the Pharmaceutical Industry. Source: http://i3health.eu/wp-content/uploads/2016/01/Presentation-E.Croufer-.pdf, last visited: 2017/3/26.GBI Research (2015). Life Cycle Management Strategies – Optimizing Revenues and Defending Generic Competition (sample). Source: https://www.marketresearch.com/product/sample-9237271.pdf, last visited: 2017/3/24.Murray Aitken, Michael Kleinock and Deanna Nass (2016). QuintilesIMS, task force. Outlook for Global Medicines through 2021. Source: http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports/outlook_for_global_medicines_through_2021, last visited: 2017/3/24.Steve Arlington, et al. (2012). PricewaterhouseCoopers, task force. From vision to decision Pharma 2020. Source: https://www.pwc.com/gx/en/pharma-life-sciences/pharma2020/assets/pwc-pharma-success-strategies.pdf, last visited: 2017/3/24.United Nations, Department of Economic and Social Affairs, Population Division (2015). World Population Prospects: The 2015 Revision, Key Findings and Advance Tables. Working Paper No. ESA/P/WP. 241.網際網路Alex Philippidis (2017). Genetic Engineering & Biotechnology News. The Top 15 Best-Selling Drugs of 2016. Source: http://www.genengnews.com/the-lists/the-top-15-best-selling-drugs-of-2016/77900868, last visited: 2017/3/24.Allen Sokal and Bart Gerstenblith (2010). The Hatch-Waxman Act: Encouraging Innovation and Generic Drug Competition. Finnegan articles. Source: http://www.finnegan.com/zh-CHT/resources/articles/articlesdetail.aspx?news=dfef53ed-54e4-491a-802a-01becb1f47bb, last visited: 2017/4/10.Bayer Official Website: A Journey through the History of Bayer. Source: https://www.bayer.com/en/history.aspx, last visited: 2017/4/24.Beth Bulik (2017). FiercePharma: Second time`s the charm? Pfizer tries again with OTC Viagra in the U.K. Source: http://www.fiercepharma.com/marketing/second-time-charm-pfizer-tries-again-for-otc-viagra-uk, last visited: 2017/5/12.Bio JobBlog (2008). Direct-to-Consumer Drug (DTC) Pharmaceutical Advertising Really is Big Business! Source: http://biojobsblog.com/2008/06/13/direct-to-consumer-drug-dtc-pharmaceutical-advertising-really-is-big-business/, last visited: 2017/5/8.David Phillips (2013) Forbes: Pfizer`s Expiring Viagra Patent Adversely Affects Other Drugmakers Too. Source: https://www.forbes.com/sites/investor/2013/12/20/pfizers-expiring-viagra-patent-adversely-affects-other-drugmakers-too/#26ba30a468d4, last visited: 2017/5/12.Don Amerman (2012). AccessRx: The Current Price of Viagra. Source: https://www.accessrx.com/blog/erectile-dysfunction/viagra/the-current-price-of-viagra-is-22-12-m1018/#, last visited: 2017/4/3.DTC Perspectives (2011). Source: http://www.dtcperspectives.com/content/editor/files/June2011/Spending%20Review.pdf, last visited: 2017/5/8.EMA – Assessment Report: Viagra. Source: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000202/WC500146784.pdf, last visited: 2017/4/30.Erik Lief (2016). American Council on Science and Health: Viagra & Cialis Make Prices Rise, Too, Defying Market Forces. Source: http://www.acsh.org/news/2016/12/05/viagra-cialis-make-prices-rise-too-defying-market-forces-10536, last visited: 2017/4/3.Jim Edwards (2010). CBS Money Watch: The Price of Lilly`s Cialis Has Doubled Since Its Launch. Source: http://www.cbsnews.com/news/the-price-of-lillys-cialis-has-doubled-since-its-launch/, last visited: 2017/4/3.Jim Edwards (2011). CBS Money Watch: Swelling Sales: Lilly to Push Cialis for Prostate Health (2011). Source: http://www.cbsnews.com/news/swelling-sales-lilly-to-push-cialis-for-prostate-health/, last visited: 2017/5/9.Lilly Official Website: Milestones of Lilly Caring and Discovery. Source: https://www.lilly.com/milestones-of-lilly-caring-and-discovery, last visited: 2017/4/24.Lilly Official Website: Sanofi and Lilly Announce Licensing Agreement for Cialis® (tadalafil) OTC. Source: https://investor.lilly.com/releasedetail.cfm?ReleaseID=850797, last visited: 2017/5/14MM&M (2016). 2015 DTC Spending: All the Data in One Place. Source: http://www.mmm-online.com/campaigns/2015-dtc-spending-all-the-data-in-one-place/article/486425/3/, last visited: 2017/5/8.New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. Source: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm20025676.htm, last visited: 2017/3/29Niraj Dawar (2013). Harvard Business Review: When Marketing Is Strategy. Source: https://hbr.org/2013/12/when-marketing-is-strategy, last visited: 2017/5/9.Package Insert of Cilais, http://pi.lilly.com/us/cialis-pi.pdf, last visited:2017/5/12.Package Insert of Staxyn, FDA Database. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200179lbl.pdf, last visited:2017/5/14.Pfizer Official Website: Company History. Source: http://www.pfizer.com/about/history/all, last visited: 2017/4/24.Sabre Stimulation Center: PSF Pharm Salesforce Sim. Source: http://www.sabresim.com.cn/english.php?s=/simulation/index/id/4, last visited: 2017/3/26.Scott Hensley (2013). Pfizer Goes Direct with Online Viagra Sales to Men. Source: http://www.npr.org/sections/health-shots/2013/05/06/181577694/pfizer-goes-direct-with-viagra-sales-to-men, last visited: 2017/5/12.Simon King (2014). FirstWord Lists – The 20 Largest Pharma M&A Deals. Source: https://www.firstwordpharma.com/node/1211072, last visited: 2017/3/27.USFDA official website. “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules — Guidance for Industry”. Source: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377938.pdf, last visited: 2017/5/19.USFDA Website: A Brief Overview of Risk Evaluation & Mitigation Strategies (REMS). Source: https://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM328784.pdf, last visited: 2017/4/12.USFDA: ANDA (Generic) Drug Approvals - Previous Years. Source: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/drugandbiologicapprovalreports/andagenericdrugapprovals/ucm050527.htm, last visited: 2017/5/9.USPTO Website: Patent Terms Extended Under 35 USC §156. Source: https://www.uspto.gov/patent/laws-and-regulations/patent-term-extension/patent-terms-extended-under-35-usc-156, last visited: 2017/4/16.資料庫ClinicalTrials.gov. Source: https://clinicaltrials.gov/ct2/homeDrugs@FDA: FDA Approved Drug Products. Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfmOrange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, Patent and Exclusivity. Source: https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm?resetfields=1Pillbox: United States National Library of Medicine – National Institute of Health. Source: https://pillbox.nlm.nih.gov/pillimage/search.phpUSPTO Patent Full-text and Image Database. Source: http://patft.uspto.gov/netahtml/PTO/index.htmlUSPTO Trademark Electronic Search System (TESS). Source: http://tmsearch.uspto.gov/bin/gate.exe?f=tess&state=4801:7a334y.1.1其他Elie Ofek (2010). Product Team Cialis: Getting Ready to Market. Harvard Business School Publishing, Harvard University.Elie Ofek and Natalie Kindred (2012). Cialis Lifecycle Management: Lilly’s BPH Dilemma. Harvard Business School Publishing, Harvard University.Gerry Yemen and Scott Snell (2012). AstraZeneca: Transforming How New Medicines Flow to Patients. Darden Graduate School of Business Publishing, University of Virginia.Harvard Business School Publishing. Harvard University.Mark Parry (2003). Cialis. Darden Graduate School of Business Publishing, University of Virginia. 描述 碩士
國立政治大學
科技管理與智慧財產研究所
104364102資料來源 http://thesis.lib.nccu.edu.tw/record/#G0104364102 資料類型 thesis dc.contributor.advisor 陳桂恒 zh_TW dc.contributor.advisor Chan, Keith en_US dc.contributor.author (Authors) 張恭銘 zh_TW dc.contributor.author (Authors) Chang, Kung-Ming en_US dc.creator (作者) 張恭銘 zh_TW dc.creator (作者) Chang, Kung-Ming en_US dc.date (日期) 2017 en_US dc.date.accessioned 10-Aug-2018 11:05:02 (UTC+8) - dc.date.available 10-Aug-2018 11:05:02 (UTC+8) - dc.date.issued (上傳時間) 10-Aug-2018 11:05:02 (UTC+8) - dc.identifier (Other Identifiers) G0104364102 en_US dc.identifier.uri (URI) http://nccur.lib.nccu.edu.tw/handle/140.119/119319 - dc.description (描述) 碩士 zh_TW dc.description (描述) 國立政治大學 zh_TW dc.description (描述) 科技管理與智慧財產研究所 zh_TW dc.description (描述) 104364102 zh_TW dc.description.abstract (摘要) 藥品生命週期管理策略是透過一連串經創新與制度的應用來延長藥品生命週期，並將獲利極大化的作為。近年來，由於大藥廠之研發能量不足等困境，藥品生命週期管理之議題更加受到重視，其應用的策略亦相當豐富與多樣，相當值得開始有新藥成果的台灣廠商參考與學習。本研究以輝瑞—威而鋼®、禮來—犀利士®以及拜耳—樂威壯®作為研究對象，並將藥品生命週期管理策略分為研究開發、商業化、智財法規等三大策略構面，藉由回顧性個案分析法以及案例比較分析法，了解個案公司在藥品生命週期管理議題之策略運用、時機選擇及互動關係，從中歸納出結論並提供台灣藥廠對應之建議。本研究發現，威而鋼®透過積極的藥品生命週期管理策略之佈局與運用，大大延續了藥物之競爭力與獲利，包含擴張新適應症、建構產品家族、善用商業外觀、創造連續的專屬權等等。犀利士®亦透過積極投入藥品生命週期管理，包含新劑型、新適應症、差異化的推廣策略、創造連續的專屬權…等方式，最終擊敗威而鋼®成為市場的領頭羊。反觀樂威壯®則較為不作為，使得營收與其他兩名競爭者有顯著差距。透過本研究歸納之發現與結論，可得知藥品生命週期管理是一門搶時間的學問；藥廠對於藥品生命週期管理策略的積極與消極作為對藥物之營收表現有顯著影響；藥品生命週期管理策略亦有風險；藥品生命週期不僅為跨部門跨領域之議題，更可透過合作來創造優勢…等。期許本研究能嘗試補足台灣關於藥品生命週期管理策略之研究領域，同時促進國內生技產業界對該領域之重視。 zh_TW dc.description.abstract (摘要) Drug life cycle management (LCM) strategy is a way to maximize revenue and the lifespan of a drug compound. With the increasing costs and time on the R&D processes and many other reasons, LCM becomes a significant topic for the pharmaceutical companies.The key LCM strategies can be categorized into development, commercial and IP/regulatory scopes. This thesis focuses on the top 3 PDE5 inhibitor class drugs, Viagra®, Cialis® and Levitra®, trying to illustrate the different options and strategies in their drug LCM through retrospective study and case analysis method.This thesis indicates that Viagra® performed the best in its LCM via combining multiple strategies at the right timing, inclusive of new indication expansion, family of products establishment, trade dress protection, etc. And Cialis®, the third-in-class drug in the PDE5i class, competed with Viagra® by aggressively applying various LCM strategies, including new formulation, new indication expansion, promotion differentiation and sequential exclusivities. In contrast, Levitra® was a relatively passive player in the game. As the result, Viagra® ranked the top in erectile dysfunction market for many years. While® Cialis pursued closely and beat Viagra® in the end. Levitra®, without a doubt, earned far less than the other two drugs.This thesis shows that the drug LCM is a cross-functional task, and the strategies are extremely rich and varied. A successful LCM needs lots of preparations and investments in order to earn more time and to differentiate from the competitors. en_US dc.description.tableofcontents 第一章 緒論 1第一節 研究背景 1第二節 研究動機 4第三節 研究目的與問題 6第四節 研究方法 6第五節 研究架構 9第六節 研究限制 10第二章 文獻探討 11第一節 製藥產業 11壹、 全球製藥產業現況 11貳、 製藥產業之價值鏈 14參、 美國藥品之重要法規制度 19第二節 生命週期管理 27壹、 產品生命週期管理理論 27貳、 製藥產業之產品生命週期 29參、 藥品生命週期管理策略 31第三節 勃起功能障礙適應症 43壹、 適應症簡介 43貳、 藥品機轉簡介 45參、 主要領導廠商與藥品 47第三章 個案研究 50第一節 輝瑞—威而鋼®（Pfizer—Viagra®）50壹、 公司與藥品發展簡介 50貳、 藥品生命週期管理分析 53一、 研究開發策略構面 53二、 商業化策略構面 56三、 智財法規策略構面 60參、 威而鋼®個案小節 65第二節 禮來—犀利士®（Eli Lilly—Cialis®）67壹、 公司與藥品簡介 67貳、 藥品生命週期管理分析 70一、 研究開發策略構面 70二、 商業化策略構面 72三、 智財法規策略構面 76參、 犀利士®個案小節 79第三節 拜耳—樂威壯®（Bayer—Levitra®）81壹、 公司與藥品簡介 81貳、 藥品生命週期管理分析 84一、 研究開發策略構面 84二、 商業化策略構面 85三、 智財法規策略構面 86參、 樂威壯®個案小節 89第四章 研究發現與討論 90第一節 個案彙總比較 90壹、 個案藥物之營收表現 90貳、 個案之藥品生命週期週期管理策略比較彙總 91參、 個案之藥品生命週期管理策略選擇與時間點 94第二節 發現與討論 98壹、 整體面之研究發現 98貳、 研究開發構面之研究發現 101參、 商業化構面之研究發現 105肆、 智財法規構面之研究發現 108第五章 結論與建議 109第一節 研究結論 109壹、 個案公司之藥品生命週期管理策略運用與時機選擇 109貳、 個案公司生命週期管理之互動關係 110參、 個案公司生命週期管理之成效與啟示 110肆、 研究總結 111第二節 研究建議 112壹、 對實務界之建議 112貳、 對後續研究之建議 114參考文獻 117中文部分 117英文部分 120 zh_TW dc.format.extent 6750004 bytes - dc.format.mimetype application/pdf - dc.source.uri (資料來源) http://thesis.lib.nccu.edu.tw/record/#G0104364102 en_US dc.subject (關鍵詞) 藥品 zh_TW dc.subject (關鍵詞) 生命週期管理策略 zh_TW dc.subject (關鍵詞) 大藥廠 zh_TW dc.subject (關鍵詞) 威而鋼® zh_TW dc.subject (關鍵詞) 犀利士® zh_TW dc.subject (關鍵詞) 樂威壯® zh_TW dc.subject (關鍵詞) Drug en_US dc.subject (關鍵詞) Life cycle management strategy en_US dc.subject (關鍵詞) Big pharma en_US dc.subject (關鍵詞) Viagra® en_US dc.subject (關鍵詞) Cialis® en_US dc.subject (關鍵詞) Levitra® en_US dc.title (題名) 大藥廠之藥品生命週期管理策略—以威而鋼®、犀利士®與樂威壯®為例 zh_TW dc.title (題名) Drug life cycle management strategies for big pharma - The case studies on Viagra®, Cialis® and Levitra® en_US dc.type (資料類型) thesis en_US dc.relation.reference (參考文獻) 中文部分書籍克萊頓．克里斯坦森、杰羅姆．格羅斯曼、黃傑升 著，朱恒鵬、張琦 譯（2015）。創新者的處方：顛覆式創新如何改變醫療。一版。北京：中國人民大學出版社。羅淑慧、陳麗敏（2010）。藥品再創價值的策略運用與發展趨勢。經濟部技術處委託財團法人生物技術開發中心之專題研究成果報告。台北市：經濟部ITIS專案辦公室。期刊陳翠華（2008）。我國醫藥品專利權期間延長制度之探討(上)。智慧財產權月刊，114期。台北：經濟部智慧財產局。研究計畫馮震宇、丘耀華、盧憶、陳香羽（2012）。逆向付款(Reverse Payment)之法律爭議與政策研究研究成果報告（精簡版）。行政院國家科學委員會專題研究計畫。未出版。取自：https://nccur.lib.nccu.edu.tw/bitstream/140.119/55949/1/100-2410-H004-021.pdf，最後瀏覽日：2017/4/12。經濟部智慧財產局（2014）。美國專利連結與橘皮書登錄制度研究。經濟部智慧財產局委託理律法律事務所之專題研究成果報告（編號：019104155-1）。未出版。取自：https://www.tipo.gov.tw/public/Attachment/511916312153.pdf，最後瀏覽日：2017/4/12。碩博士學位論文吳東哲（2015）。藥品的核准前專利爭端解決程序—以美國專利連結為借鏡，國立政治大學法律科際整合研究所碩士論文。取自臺灣博碩士論文系統。吳東霖（2004）。治療男性勃起功能障礙藥物在台灣市場競爭策略之探討，國立中山大學管理學院高階經營碩士學程在職專班碩士論文。取自臺灣博碩士論文系統。吳豐江（2015）。美國藥物專利布局與其相應之研究開發與法規活動—以諾華藥廠之 Gleevec®為例，國立政治大學科技管理與智慧財產研究所碩士論文。取自臺灣博碩士論文系統。網際網路中華民國衛生福利部 – 衛部藥輸字第026295號 。取自：http://www.fda.gov.tw/MLMS/H0001D.aspx?Type=Lic&LicId=52026295，最後瀏覽日：2017/5/30科技產業資訊室。關於專利家族（patent family）。取自：http://cdnet.stpi.narl.org.tw/techroom/pclass/pclass006.htm，最後瀏覽日：2017/5/30。葉雲卿（2015）。淺談醫藥專利典型權利請求項。北美智權報。取自：http://www.naipo.com/Portals/1/web_tw/Knowledge_Center/Biotechnology/publish-18.htm，最後瀏覽日：2017/4/11。其他李世仁博士（2016）。《Crossing the Chasm: From Bench to Business》投影片，生技醫藥產學合作交流研討會。台北市：台灣研發型生技新藥發展協會。陳桂恒博士（2016）。生技商業化：科學、法規、法律與商業化基本功—新藥、類新藥、學名藥藥品批准。國立政治大學科技管理與智慧財產研究所課程講義。勤業眾信趨勢分析報告（2016）。生技醫療產業展望報告。取自：https://www2.deloitte.com/content/dam/Deloitte/tw/Documents/life-sciences-health-care/tw-2016lshc-outlook.pdf，最後瀏覽日：2017/3/24.英文部分書籍David Jobber and John Fahy (2003). Foundations of Marketing. Berkshire, England: Mcgraw-Hill Education.Donald Kirsch (2014). Therapeutic Drug Development and Human Clinical Trials. In Craig Shimasaki, et al. (Eds.). Biotechnology Entrepreneurship. Massachusetts, MA: Elsevier Inc.Jay Baglia (2005). The Viagra Ad Venture: Masculinity, Media, and the Performance of Sexual Health. New York, NY: Peter Lang Publishing Inc.Kappe Eelco (2014). Pharmaceutical Life Cycle Extension Strategies. In Min Ding, Jehoshua Eliashberg, and Stefan Stremersh, et al. (Eds.). Innovation and Marketing in the Pharmaceutical Industry. Philadelphia, PA: Springer Science + Business Media.Tony Ellery and Neal Hansen (2012). Pharmaceutical Lifecycle Management: Making the Most of Each and Every Brand. New Jersey, NJ: A John Wiley & Sons, Inc., Publication.期刊Asher Mullard (2017). 2016 FDA Drug Approvals. Nature Reviews Drug Discovery, Vol. 16, Feb. 2017, pp. 73-76.David Cavalla (2003). The Extended Pharmaceutical Enterprise. Drug Discovery Today, Vol. 8, No. 6, Mar. 2003, pp. 267-274.Henry Feldman, et al. Impotence and Its Medical and Psychosocial Correlates, Massachusetts Male Aging Study. The Journal of Urology, Vol. 151, Jan. 1994, pp. 54-61.Hossein Ghofrani, Ian Osterloh and Friedrich Grimminger (2006). Sildenafil: from Angina to Erectile Dysfunction to Pulmonary Hypertension and Beyond. Nature Review Drug Discovery, Vol. 5, Aug. 2006, pp. 689-702.James Conley, Peter Bican and Holger Ernst (2013). Value Articulation: A Framework for the Strategic Management of Intellectual Property. California Management Review, Vol. 55, No. 4, pp. 102-120.Jeremy Greene and and Aaron Kesselheim (2011). Why Do the Same Drugs Look Different? Pills, Trade Dress, and Public Health. The New England Journal of Medicine, Vol. 365, Jul. 2011, pp. 83-89.Katherine Neumeyer and Peter Kirkpatrick (2004). Fresh from the Pipeline: Tadalafil and vardenafil. Nature Reviews Drug Discovery, Vol. 3, Apr. 2004, pp. 295-296.Laura Mahecha (2006). Rx-to-OTC Switches: Trends and Factors Underlying Success. Nature Reviews Drug Discovery, Vol. 5, May. 2006, pp. 380-386.Mannching Sherry Ku (2015). Recent Trends in Specialty Pharma Business Model, Journal of Food and Drug Analysis, Vol. 23, Dec. 2015, p. 595-608.María José Abud, Bronwyn Hall and Christian Helmers (2015). An Empirical Analysis of Primary and Secondary Pharmaceutical Patents in Chile. PLoS ONE. Vol. 10, Apr. 2015, pp. 1-17.Maria Kubin, Gorm Wagner and Alex Fugl-Meyer (2003). Epidemiology of Erectile Dysfunction. International Journal of Impotence Research, Vol. 15, Feb. 2003, pp. 63-71.Myoung Cha, Abhishek Saxena, Katarzyna Smietana & Roerich Bansal (2015). Deal watch: Panning for gold: sourcing pharmaceutical innovation. Nature Reviews Drug Discovery, Vol. 14, May. 2015, p. 376.Peter Sandner and Karl Ziegelbauer (2008). Product-related Research: How Research Can Contribute to Successful Life-Cycle Management. Drug Discovery Today, Vol. 13, No. 9/10, May. 2008, pp. 457-463.Raymond Vernon (1966). International Investment and International Trade in the Product Cycle. The Quarterly Journal of Economics, Vol. 80, No. 2, May. 1966, pp. 190-207. Source: http://www.sba.muohio.edu/dunlevja/Course%20Links/EC441/Vernon.pdf, last visited: 2017/4/3.Sharon Huang and Janette Lie (2013). Phosphodiesterase-5 (PDE5) Inhibitors in the Management of Erectile Dysfunction. Pharmacy and Therapeutics, Vol. 38, No. 7, Jul. 2013, pp. 414-419.Shraddha Chowdhary (2015). A Study of Product Life Cycle Extension Strategies of Patented Drugs to Deter Entry of Generics. International Journal of Pharmaceutical Science and Health Care, Vol. 3, No. 5, May. - Jun. 2015, pp. 99-108.Ventola Lee (2011). Direct-to-Consumer Pharmaceutical Advertising. Pharmacy and Therapeutics, Vol. 36, No. 10, Oct. 2011, pp. 669-674, 681-684.分析報告Antonio Iervolino, et al. (2016). EvaluatePharma, task force. World Preview 2016, Outlook to 2022. Source: http://info.evaluategroup.com/rs/607-YGS-364/images/wp16.pdf , last visited: 2017/3/24.Arthur D. Little (2016), task force. Trends in the Pharmaceutical Industry. Source: http://i3health.eu/wp-content/uploads/2016/01/Presentation-E.Croufer-.pdf, last visited: 2017/3/26.GBI Research (2015). Life Cycle Management Strategies – Optimizing Revenues and Defending Generic Competition (sample). Source: https://www.marketresearch.com/product/sample-9237271.pdf, last visited: 2017/3/24.Murray Aitken, Michael Kleinock and Deanna Nass (2016). QuintilesIMS, task force. Outlook for Global Medicines through 2021. Source: http://www.imshealth.com/en/thought-leadership/quintilesims-institute/reports/outlook_for_global_medicines_through_2021, last visited: 2017/3/24.Steve Arlington, et al. (2012). PricewaterhouseCoopers, task force. From vision to decision Pharma 2020. Source: https://www.pwc.com/gx/en/pharma-life-sciences/pharma2020/assets/pwc-pharma-success-strategies.pdf, last visited: 2017/3/24.United Nations, Department of Economic and Social Affairs, Population Division (2015). World Population Prospects: The 2015 Revision, Key Findings and Advance Tables. Working Paper No. ESA/P/WP. 241.網際網路Alex Philippidis (2017). Genetic Engineering & Biotechnology News. The Top 15 Best-Selling Drugs of 2016. Source: http://www.genengnews.com/the-lists/the-top-15-best-selling-drugs-of-2016/77900868, last visited: 2017/3/24.Allen Sokal and Bart Gerstenblith (2010). The Hatch-Waxman Act: Encouraging Innovation and Generic Drug Competition. Finnegan articles. Source: http://www.finnegan.com/zh-CHT/resources/articles/articlesdetail.aspx?news=dfef53ed-54e4-491a-802a-01becb1f47bb, last visited: 2017/4/10.Bayer Official Website: A Journey through the History of Bayer. Source: https://www.bayer.com/en/history.aspx, last visited: 2017/4/24.Beth Bulik (2017). FiercePharma: Second time`s the charm? Pfizer tries again with OTC Viagra in the U.K. Source: http://www.fiercepharma.com/marketing/second-time-charm-pfizer-tries-again-for-otc-viagra-uk, last visited: 2017/5/12.Bio JobBlog (2008). Direct-to-Consumer Drug (DTC) Pharmaceutical Advertising Really is Big Business! Source: http://biojobsblog.com/2008/06/13/direct-to-consumer-drug-dtc-pharmaceutical-advertising-really-is-big-business/, last visited: 2017/5/8.David Phillips (2013) Forbes: Pfizer`s Expiring Viagra Patent Adversely Affects Other Drugmakers Too. Source: https://www.forbes.com/sites/investor/2013/12/20/pfizers-expiring-viagra-patent-adversely-affects-other-drugmakers-too/#26ba30a468d4, last visited: 2017/5/12.Don Amerman (2012). AccessRx: The Current Price of Viagra. Source: https://www.accessrx.com/blog/erectile-dysfunction/viagra/the-current-price-of-viagra-is-22-12-m1018/#, last visited: 2017/4/3.DTC Perspectives (2011). Source: http://www.dtcperspectives.com/content/editor/files/June2011/Spending%20Review.pdf, last visited: 2017/5/8.EMA – Assessment Report: Viagra. Source: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Assessment_Report_-_Variation/human/000202/WC500146784.pdf, last visited: 2017/4/30.Erik Lief (2016). American Council on Science and Health: Viagra & Cialis Make Prices Rise, Too, Defying Market Forces. Source: http://www.acsh.org/news/2016/12/05/viagra-cialis-make-prices-rise-too-defying-market-forces-10536, last visited: 2017/4/3.Jim Edwards (2010). CBS Money Watch: The Price of Lilly`s Cialis Has Doubled Since Its Launch. Source: http://www.cbsnews.com/news/the-price-of-lillys-cialis-has-doubled-since-its-launch/, last visited: 2017/4/3.Jim Edwards (2011). CBS Money Watch: Swelling Sales: Lilly to Push Cialis for Prostate Health (2011). Source: http://www.cbsnews.com/news/swelling-sales-lilly-to-push-cialis-for-prostate-health/, last visited: 2017/5/9.Lilly Official Website: Milestones of Lilly Caring and Discovery. Source: https://www.lilly.com/milestones-of-lilly-caring-and-discovery, last visited: 2017/4/24.Lilly Official Website: Sanofi and Lilly Announce Licensing Agreement for Cialis® (tadalafil) OTC. Source: https://investor.lilly.com/releasedetail.cfm?ReleaseID=850797, last visited: 2017/5/14MM&M (2016). 2015 DTC Spending: All the Data in One Place. Source: http://www.mmm-online.com/campaigns/2015-dtc-spending-all-the-data-in-one-place/article/486425/3/, last visited: 2017/5/8.New Drugs at FDA: CDER’s New Molecular Entities and New Therapeutic Biological Products. Source: https://www.fda.gov/Drugs/DevelopmentApprovalProcess/DrugInnovation/ucm20025676.htm, last visited: 2017/3/29Niraj Dawar (2013). Harvard Business Review: When Marketing Is Strategy. Source: https://hbr.org/2013/12/when-marketing-is-strategy, last visited: 2017/5/9.Package Insert of Cilais, http://pi.lilly.com/us/cialis-pi.pdf, last visited:2017/5/12.Package Insert of Staxyn, FDA Database. Source: https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200179lbl.pdf, last visited:2017/5/14.Pfizer Official Website: Company History. Source: http://www.pfizer.com/about/history/all, last visited: 2017/4/24.Sabre Stimulation Center: PSF Pharm Salesforce Sim. Source: http://www.sabresim.com.cn/english.php?s=/simulation/index/id/4, last visited: 2017/3/26.Scott Hensley (2013). Pfizer Goes Direct with Online Viagra Sales to Men. Source: http://www.npr.org/sections/health-shots/2013/05/06/181577694/pfizer-goes-direct-with-viagra-sales-to-men, last visited: 2017/5/12.Simon King (2014). FirstWord Lists – The 20 Largest Pharma M&A Deals. Source: https://www.firstwordpharma.com/node/1211072, last visited: 2017/3/27.USFDA official website. “Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules — Guidance for Industry”. Source: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM377938.pdf, last visited: 2017/5/19.USFDA Website: A Brief Overview of Risk Evaluation & Mitigation Strategies (REMS). Source: https://www.fda.gov/downloads/AboutFDA/Transparency/Basics/UCM328784.pdf, last visited: 2017/4/12.USFDA: ANDA (Generic) Drug Approvals - Previous Years. Source: https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/drugandbiologicapprovalreports/andagenericdrugapprovals/ucm050527.htm, last visited: 2017/5/9.USPTO Website: Patent Terms Extended Under 35 USC §156. Source: https://www.uspto.gov/patent/laws-and-regulations/patent-term-extension/patent-terms-extended-under-35-usc-156, last visited: 2017/4/16.資料庫ClinicalTrials.gov. Source: https://clinicaltrials.gov/ct2/homeDrugs@FDA: FDA Approved Drug Products. Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfmOrange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, Patent and Exclusivity. Source: https://www.accessdata.fda.gov/scripts/cder/ob/default.cfm?resetfields=1Pillbox: United States National Library of Medicine – National Institute of Health. Source: https://pillbox.nlm.nih.gov/pillimage/search.phpUSPTO Patent Full-text and Image Database. Source: http://patft.uspto.gov/netahtml/PTO/index.htmlUSPTO Trademark Electronic Search System (TESS). Source: http://tmsearch.uspto.gov/bin/gate.exe?f=tess&state=4801:7a334y.1.1其他Elie Ofek (2010). Product Team Cialis: Getting Ready to Market. Harvard Business School Publishing, Harvard University.Elie Ofek and Natalie Kindred (2012). Cialis Lifecycle Management: Lilly’s BPH Dilemma. Harvard Business School Publishing, Harvard University.Gerry Yemen and Scott Snell (2012). AstraZeneca: Transforming How New Medicines Flow to Patients. Darden Graduate School of Business Publishing, University of Virginia.Harvard Business School Publishing. Harvard University.Mark Parry (2003). Cialis. Darden Graduate School of Business Publishing, University of Virginia. zh_TW dc.identifier.doi (DOI) 10.6814/THE.NCCU.TIIPM.013.2018.F08 -
