Mylan, Inc. (MYL, MYL-PA) announced Wednesday that the U.S. Food and Drug Administration, or FDA, granted its unit, Mylan Pharmaceuticals Inc., a tentative approval for its Abbreviated New Drug Application for the Olmesartan Medoxomil and Hydrochlorothiazide tablets indicated for the treatment of high blood pressure. Mylan also confirmed that Swiss drug maker Novartis AG (NVS) has sued Mylan Pharma for patent infringement of its high cholesterol treatment drug, Lescol.
On the tentative approval, the diversified generic and specialty pharmaceutical company noted that it received the FDA approval for the 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg dosage strengths. Both tablets are the generic version of Daiichi Sankyo Co. Ltd. (DSKYF.PK)'s Benicar HCT, which according to IMS Health data had U.S. sales of roughly $535 million for the noted strengths for the year ended June 30, 2008.
Mylan Pharma, which submitted its original application for the product to the FDA on February 14, 2007, is expected to be entitled to 180 days of marketing exclusivity for Olmesartan Medoxomil Hydrochlorothiazide upon FDA approval under the provisions of the Hatch-Waxman Act.
Mylan Pharma also received very recently a tentative FDA approval for its ANDA for Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, indicated for the treatment of an enlarged prostate or Benign Prostatic Hyperplasia. This tablet is the generic version of Sanofi-Aventis (SNY)'s Uroxatral ER and according to the IMS data had U.S. sales of about $168 million for the year ending June 30, 2008, for the noted strength, Mylan noted.
In a separate release earlier today, Mylan confirmed that Novartis has filed a lawsuit against the company and Mylan Pharma in the U.S. District Court for the District of New Jersey on October 10, alleging infringement of U.S. Patent No. 5,354,772.
Novartis has sued Mylan in connection with Mylan's Fluvastatin Capsules USP, 20 mg and 40 mg , which is the generic version of Novartis' Lescol capsules, and used in the treatment of high cholesterol. Citing the IMS Health, Mylan noted that Lescol had around $60 million in annual sales. Mylan filed the ANDA for the capsules with the FDA in June.
Mylan noted further that it presently has 108 ANDAs pending FDA approval, 22 of which are potential first-to-file opportunities.
MYL is currently trading on NYSE at $7.58, down $0.24, or 3.07%, with a volume of 1.16 million shares. Meanwhile, MYL-PA closed Monday's regular trade at $546.41.
NVS on the NYSE is currently trading down by $1.86, or 3.68%, at $48.67, on a volume of 419,058 shares.
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