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The future of Generic Pharmacetical Industry in USA


It has been estimated that expiries will be happening steadily in the USA at an increasing rate, reaching 20 in 2012. Furthermore, it has been speculated that the loss in revenues will be even more catastrophic since the peak exposure period of high revenue earning products occurs in 2011, as both Plavix and Lipitor are now anticipated to come across generic competition. Also, during the four year peiod of 2009-2013, most of the major companies in this sector will also face very different levels of exposure in terms of potential loss of revenue to generic medications.

Big players such as Eli Lilly, Bristol-Myers Squibb, Pfizer, Merck and Takeda are all known to face loss of revenues amounting to up to 40%. On the other hand, manufacturers such as Abbott, Roche and Astellas will face minimum losses.

The other major drug manufacturing companies will face different levels of exposure, of an average of around 20%, and for most of these companies, 2011 and 2012 are said to be critical years. The companies that will face potential maximum exposure are Pfizer and Bristol-Myers Squibb, because of their heavy dependence on one product. Lipitor, manufactured by Pfizer accounts for nearly 25% of its total sales, and Plavix by Bristol-Myers Squibb brings about 30% of its yearly revenues.

2009 – This year brought about the patent expiries of about 10 products in Europe and 7 in the US. The most significant development in Europe for this year was the loss of market exclusivity of Pantozol and Nexium, two of the most popular drugs used as anti-ulcer drugs. In US, the most important expiries were for Prevacid, an anti-ulcer medication and Topamax, an anticonvulsant.

2010 – This year ended with loss of 6 patents in Europe and 10 in USA. Whereas in Europe the most significant part was the loss of exclusivity for Keppra, an anticonvulsant, Advair in US stole the show. The introduction of generic medications was slow in 2010. Some more products to lose their exclusivity were Aricept, Protonix and Cozaar.

2011 – This will be another bad year for the developing pharmaceutical industry, with 4 popular products losing their exclusivity this year. These combine to bring a total sales of nearly $16 billion (recorded in 2007). Furthermore, 11 products lose their patents this year, with the most significant ones being Lipitor, Zyprexa and Actos. In the US alone, a total of 13 products are set to lose their patents this year.

2012 – This year will probably see the most number of products losing their patents, with about 20 significant ones in the USA alone, and 14 in Europe. Antihypertensive drugs such as Aprovel and Atacand are among the significant losses in Europe. In the United States, three among the twenty drugs brought total revenue of $2 billion in 2007. These were Lexapro, Singulair and Diovan.

2013 – 2013 witnesses the loss of 10 patent products in Europe and 9 in the United States. Seretide, Plavix and a number of other antiviral agents lose their exclusivity in Europe. In the US, the significant developments are the loss of patent protection of Cymbalta and Aciphex.

Generic competition from 2009 – 2013: The impact made by patent expiries on the sales of major drugs is written in a 53000-word report that also provides important market data and also some deep insight that both generic and ethical pharmaceutical companies will find of use.


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