原创力文档- 1、原创力文档（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。。
- 2、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击 这里二次下载。
- 3、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。
- 4、该文档为VIP文档，如果想要下载，成为VIP会员后，下载免费。
- 5、成为VIP后，下载本文档将扣除1次下载权益。下载后，不支持退款、换文档。如有疑问请联系我们。
- 6、成为VIP后，您将拥有八大权益，权益包括：VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
- 7、VIP文档为合作方或网友上传，每下载1次， 网站将根据用户上传文档的质量评分、类型等，对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档
查看更多
Current Trend of Generics - Opportunities and Challenges Increase of World Total Population 0.6 Billion/Decade Current Trend of Generics - Opportunities and Challenges Current Trend of Generics - Opportunities and Challenges Current Trend of Generics - Opportunities and Challenges Generic Prescription Drug Sales in China and USA Current Trend of Generics - Opportunities and Challenges Opportunity for generic industry in 5 years - $87 billion from 2009 to 2013 due to the expiry of patents for blockbuster drugs (source: Goldman Sachs) 2009 E - $650 million 2010 E - $23,451 million 2011 E - $20,157 million 2012 E - $29,647 million 2013 E - $13,170 million Challenges in Global Pharmaceutical Industry Major Consolidations Mergers between PMA companies recently Pfizer with Wyeth Merck with Schering-Plough Roche with Genetech Mergers between Generic companies Watson with Andrx Teva with Barr Challenges in Global Generic Pharmaceutical Industry Pricing pressure Product life cycle management from brand companies – High barrier entry Authorized generics – Minimize the benefits for FTF PIV ANDA filings Citizens petition – Delay generic market entrance Enforcement of regulations Formulation and Process Development of Oral ER Dosage Forms in Generic Industry Case Study – Cardizem CD (Once Daily ER Capsules by Andrx) Patent search – Legal Opinion Non-infringement Invalidity – None enforceable Product development Pre-formulation Formulation with pilot and pivotal BE studies Process development – Defining process parameters Formulation and Process Development of Oral ER Dosage Forms in Generic Industry US Patent for Brand Product – 5,286,497 Claim 1: A diltiazem formulation suitable for once-a-day oral administration comprising a blend of: A) a sufficient quantity of rapid release diltiazem beads which further comprise 1) a diltiazem core containing an effective amount of diltiazem of a pharmaceutically acceptable salt thereof, optionally in association with pharmaceutically ac
文档评论（0）