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Para IV Pipeline Analysis of Indian Pharma Companies
MP Advisors, Jan 2011, Pages: 215
As we near the patent cliff of 2014, many Indian companies are choosing the Para IV route to grab a higher market share, both in value and volume. The impact of Indian companies can be gauged by the fact that Indian companies account for more than 50% of on-going litigations and they have secured 180-day exclusivity in 6 of the world's top 11 products under litigation.
This is considered the most comprehensive report on Indian pharma's Para IV pipeline ever published. This report is a comprehensive study of Para IV pipeline of the Indian industries and likely upside from all of the products for each company. Each product is studied as a case study and its potential opportunity is evaluated based on various aspects of the patent litigation.
Each product's case study is based on the legal understanding regarding its litigation and also measures taken outside the courts (like settlements, citizen petitions etc). Importantly this report includes such products that are not litigated and claims of generics accepted by innovators – something that never comes in public until the generic is launched. This report attempts to anticipate the next step by generic companies or innovators such as possible settlements and possible launch dates in case of undisclosed settlements.
The report is prepared from (1) court filings and judgements (2) official filings and announcements of the companies involved (3) MP Advisor's communications with the companies involved (4) USFDA's actions and announcements (5) patent documents and (6) at times, from relevant third parties like marketing and manufacturing partner for a drug (if other than the innovator) etc . In other words, this is not merely a database, but a tool with in-depth insights for every product (and not just every litigation) such that an expert in the field can easily gauge opportunities for various parties.To a money manager, this will help in anticipating a likely win or loss in any litigation in advance of making meaningful investment decisions.
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