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Patent Expiry Strategies of Big Pharma
Pharma-Reports, Jan 2012, Pages: 102
With an unusually high number of blockbuster drugs going off patent by 2013, many pharmaceutical companies are under a lot of pressure to develop innovative strategies to counteract the revenue loss from these drugs.
Not only is Pharma facing continuous declining sales growth, but erosion of branded drugs by generics following patent expiry is increasing, driven by evolving payer initiatives to incentivize generic use.
This report analyzes the strategies pharmaceutical companies are employing before and after patent expiration to minimize loss to their brand.
Brand name drug companies, such as Pfizer and GSK, are using a number of strategies to either extend their market exclusivity period for their blockbuster drugs and resorting to mergers and acquisitions to prevent generic competition to their drugs.
The report begins with an analysis of patents in the pharmaceutical industry. This section is a basic guide to understanding how patents are granted, what is the exclusivity period of a drug, industry response to impending patent expirations, the role of the Hatch-Waxman ACT, and the importance of Abbreviated New Drug Applications (ANDAs).
Key Topics Covered:
- Understanding Pharmaceutical Industry Patents
- Key Patent Expiries Facing the Industry
- Mergers and Acquisitions
- Cost-Cutting Programs
- Possible Strategies for Companies to Boost Revenues
- Why the Industry Needs a Strong Patent Portfolio
- High Cost of Drug Development
- Importance of the Drug Discovery Phase
- Optimizing Returns from Blockbuster Drugs
- Patent Cliff Facing the Industry
- Decline on R&D Investment Returns
- Patent Losses for Blockbuster Drug
- Advantage for Generic Companies
- Low R&D Productivity
- Regulations for Drug Approval Getting Stricter
- Impact of Pricing and Reimbursement Policies
- Patent Layering Strategy
- Strategies to Employ After Patent Expiry
- Orange Book Listings and Delisting
- Emergence of Authorized Generics
We analyze the need for a stronger patent portfolio in the pharmaceutical industry by examining the many challenges and trends the industry is facing at present as well as in the coming years. With the cost of drug development increasing, it is becoming a struggle for even major pharmaceutical companies to continue developing blockbuster drugs on a regular basis.
We examine the strategies pharma majors are employing before patent expiry, including patent layering strategy, the introduction of new formulations and new indications, and the shift of pharmaceutical companies to developing their own generic versions of blockbuster drugs.
Strategies to employ after patent expiries are also analyzed in the report, including the importance of Orange Book listings and delistings as well as the emergence of authorized generics.
Profiles of leading industry players include:
Johnson & Johnson
Pfizer
GlaxoSmithKline plc
Novartis AG
Sanofi SA
AstraZeneca plc
Eli Lilly & Co.
Merck & Co., Inc.
Abbott Laboratories
Roche Holding Ltd.
This report is a must-have for every pharmaceutical executive read-list
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