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Need for Robust Patent Portfolio in the Midst of Blockbuster Drugs Expiry

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Patent Strategies - Effective Strategies for Extension of Product Lifecycles and Combating Aggressive Generics Markets


Need for Robust Patent Portfolio in the Midst of Blockbuster Drugs Expiry

The pharmaceutical industry is going to experience major patent expiries during 2010-2014, of which 2010 to 2012 are expected to be peak years, with the loss of patents for drugs whose sales were more than $60 billion during 2009.

In 2010, major drugs like Lipitor, Cozaar, Advair, Arimidex, Flomax and Gemzar, with combined sales revenues of more than $24 billion, are expected to face generic competition. In 2011, nine drugs of six companies are going to experience a major impact of patent expirations. The drugs include Femara, Xalaton, Seroquel, Zyprexa, Almita, Aprovel, Plavix, Singulair and Zoladex, which together account for more than $20 billion sales revenue all over the world.

In contrast to 2011, 2012 is going to have less patent expirations, but the impact on sales is going to be greater than that of 2011; more than $15 billion for three drug expiries. Novartis’ blockbuster drug Diovan, with sales revenue above $6 billion; Bristol-Myers Squibb’s Avapro, with sales revenue above $6 billion; and Sanofi-Aventis’ Lovenox, with sales revenue of $3 billion, are expected to expire in 2012. Eli Lilly’s Cymbalta is the only major drug to face generic competition in 2013, with sales revenue of $3 billion all over the world. In 2014, Roche’s blockbuster drug Rituxan is going off-patent, creating impact on $6 billion of sales revenues. The full impact of patients shifting to lower-cost generic


alternatives for all these products, as well as other brands in their therapy classes, will mostly be felt in 2012 and 2013, due to the timing and expected competitive intensity among generic entrants.

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Aggressive Generic Companies to Erode Sales of Branded Companies

Many drug makers are dismayed about the approaching years, as billions of dollars are lost when the patents surrounding big drugs, such as Lipitor, are set to expire. The big firms that will most likely be affected during 2010 to 2014 are Pfizer, Bristol-Myers Squibb, GlaxoSmithKline, Novartis, Eli Lilly, AstraZeneca, Roche and Sanofi-Aventis.

The number of Abbreviated New Drug Applications (ANDAs) filed by generic companies has significantly increased during 2007 and 2009, indicating upcoming generic competition.


Combating Generics with Formulation Variants (Tablets, IVs, Syrups) – a Key Pre-Patent Expiry Strategy

Introducing “new formulations” is one of the most extensively used strategies after indication expansion. The core process involves changing the old drug into a more convenient or a more attractive form which has more potential to sell than the older version. As a sophisticated lifecycle management technique, not many companies adopt this strategy since it requires extensive planning and implementation.

In the current pharmaceutical pipeline, some of the main drugs undergoing formulation changes include Eisai’s Aricept and Aciphex/Pariet, Astellas’ Ambien (zolpidem) and Vesicare (solifenacin), Genentech’s Xolair (omalizumab) and Takeda’s Actos (pioglitazone hydrochloride).

GBI Research, the leading business intelligence provider, has released its latest research, “Effective Patent Strategies for Brand Protection, Extension of Product Lifecycle and Combating Aggressive Generics Markets.” It provides key data, information and analysis on the main patent protection strategies being implemented by pharmaceutical companies. The report provides information on the pre-patent expiry and post-patent expiry strategies, the reasons why companies implement patent strategies and the challenges faced by them. This


report provides comprehensive analysis of five key patent strategies (new indications, formulation variants, extended/controlled released versions, Rx-to-OTC switches, and store brand generics) using case studies. It also reviews the factors determining the success and failure of the strategies, providing an understanding of how to ensure success for maintaining effective patent portfolios.

It is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts.

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For more details contact:

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