The generic player M/S Teva Pharma announced (in a press release Here ) that the U.S. Food and Drug Administration (USFDA) has granted final approval for the Company's generic versions of innovator Merck's antihypertensive Losartan (Cozaar) 25 mg, 50 mg and 100 mg tablets and Losartan + HCTZ (Hyzaar) 100+ 12.5, 50+12.5, 100 + 25 mg tablets.
Importantly, company is first to file on these products and USFDA has awarded 180-day Hatch-Waxman statutory exclusivity to market these products to Teva. Also, generic players Roxane, Torrent and Mylan have got final approval for Losartan + HCTZ (Hyzaar) 100 +12.5 mg tablets (no exclusivity on this strength).
Also, generic player Sandoz has launched authorized generic of this product.
As per USFDA database, these generic players have got final approval on Apr 6, 2010 after the expiry of compound patent US5153197, which covered Losartan as product.
Teva has got 180 days exclusivity challenge by challenging US5608075 (Expiry: Sep 4, 2009), which covers various polymorphic forms of Losartan Potassium. After Teva's ANDA filing, innovator Merck filed patent delisting request on '075 patent. However, Teva opposed this delisting and after a long legal battle with USFDA (full of twists ), Teva got exclusivity on this product. Also, generic players Roxane and Apotex challenged USFDA decision of grant of FTF 180 days exclusivity to Teva.
The brand products had combined annual sales of approximately $1.6 billion in the United States, based on IMS sales data.
For an excellent review on court cases and Teva’s dispute with USFDA, you can refer to Mr. Kurt R. Kast’ FDA Law Blog Here .
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