comparative analysis of marketed drugs in major indications

1. Comparative Analysis of Marketed Drugs in MajorIndications - Patent Cliff to Set Off Intense PriceCompetition in High Volume Markets

2. Patent Expiries will Intensify the Competition among Generic Players A patent offers the patentee a monopoly of market exclusivity, and ensures returns on research investments in the absence of competition, therefore encouraging research into novel treatment options. In dyslipidemia, Lipitor is the world’s biggest selling statin drug, with revenue of $11,434m in 2009. It was approved by the US FDA (United States Food and Drug Administration) in 1996. More than half of the antidyslipidemic market is commanded by Lipitor, which is a gold standard therapy. On January 6, 2009, the US Patent and Trademark office reissued a patent to Lipitor that will expire in June 2011. Apotex and Teva are seeking US FDA approval to sell generic versions of Lipitor, and were sued by Pfizer in 2008. Exelon is available as a capsule, liquid and a patch form. The Exelon patch was recently approved by the FDA in 2007, and will not be available in generic form until the patent expires (2014). In 2007, Watson Pharmaceuticals was given tentative approval for its ANDA (Abbreviated New Drug Application) by the US FDA, to manufacture generic Exelon. Novartis and Watson Pharmaceuticals came to an agreement over the Exelon patent litigation. According to the agreement, Watson will not commence marketing its generic equivalent product until sometime prior to the expiration of the patents covering Exelon.

3. Teva Pharmaceuticals has received US FDA approval for the company’s ANDA, to market the generic version of Eisai’s Aricept. Need for Extensions in the Midst of Competition The monopoly granted by a patent lasts for a limited period of time. Extensions provide opportunities for a major marketed product to revive its sales and growth in the midst of heavy generic competition. Extensions can be obtained in terms of additional indications for the drug, or new dosage forms of the drug. Tracleer received approval from the European regulatory authorities for the reduction in the number of new digital ulcers in patients suffering from systemic sclerosis and ongoing digital ulcer disease. Additionally, a quadrisect, dispersible 32mg tablet formulation of Tracleer has been approved in the EU (European Union) for the treatment of PAH (Pulmonary Arterial Hypertension) in children aged from two years. For further details, please click or add the below link to your browser: http://gbiresearch.com/Report.aspx?ID=Comparitive-Analysis-of-Marketed-Drugs-in-Major-Indications-Patent-Cliff-to-Set-Off-Intense-Price-Competition-in-High-Volume-Markets&ReportType=Industry_Report&coreindustry=ALL&Title=Pharmaceuticals_and_Healthcare&CompanyID=ssrve

4. Remicade was first approved by the FDA for Crohn’s disease in 1998. Following this approval and successful clinical trials for other indications, the drug received FDA approval for several other indications, including psoriasis, ulcerative colitis, psoriatic arthritis, RA (Rheumatoid Arthritis) and ankylosing spondylitis. Aricept went off-patent in 2010. In 2009, Eisai received approval for a new oral jelly formulation of Aricept, for the treatment of Alzheimer’s disease in Japan. It is an easier, orally administered medication for people who have difficulty in swallowing. The addition of new oral jelly formulations to the already available tablet, fine granule, and orally rapid disintegrating tablet formulations will help to bring better drug compliance among patients, and also to improve quality of life. Licensing of Major Marketed Drugs and Acquisitions will Boost Players The opportunity to market a drug with a sizeable market share in a major indication comes from obtaining marketing rights from the current marketer through license agreements or acquisitions. Ventavis inhalation solution was developed by Bayer Schering Pharma. The drug was approved by the FDA on December 29, 2004. CoTherix, Inc has been given rights by Bayer to develop and commercialize Ventavis in the US. Actelion gained the licensing rights of Ventavis through the acquisition of CoTheris Inc. in 2006.

5. Lovaza was developed by Reliant Pharmaceuticals. In 2007, GlaxoSmithKline completed a deal to acquire Reliant Pharmaceuticals ($1.6 billion). The acquisition of Reliant gave GlaxoSmithKline marketing rights for Lovaza. Enbrel was originally developed by Immunex, which was acquired by Amgen in 2001. This acquisition has strengthened Amgen’s position in the arthritis market. From the time of its approval, acceptance of the drug has increased due to its safety and efficacy profiles, which makes it a strong competitor in the RA market GBI Research, the leading business intelligence provider, has released its latest research, “Comparative Analysis of Marketed Drugs in Major Indications - Patent Cliff to Set Off Intense Price Competition in High Volume Markets”, which provides insights regarding the comparative analysis of marketed drugs based on safety, efficacy, cost of therapy and total sales revenue. The report also delves deep into the descriptions of every marketed drug, discussing their safety, efficacy, cost of therapy and clinical studies. For further details, please click or add the below link to your browser: http://gbiresearch.com/Report.aspx?ID=Comparitive-Analysis-of-Marketed-Drugs-in-Major-Indications-Patent-Cliff-to-Set-Off-Intense-Price-Competition-in-High-Volume-Markets&ReportType=Industry_Report&coreindustry=ALL&Title=Pharmaceuticals_and_Healthcare&CompanyID=ssrve

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