Friday, May 18, 2012

Sagent launched atracurium

Sagent Pharmaceuticals announced that it has launched the generic version of Tracrium (atracurium besylate) which is a nondepolarizing skeletal muscle relaxant that is indicated as an adjunct to general anesthesia to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation.

Based on IMS data, the sales of atracurium in the US was 2.4M in the 12-month ended March 2012.


Watson confirmed patent lawsuit from Warner Chilcott

Watson announced that it has filed an abbreviated new drug application with the US FDA seeking approval to market generic Lo Loestrin Fe which is a combination of norethindrone acetate/ethinyl estradiol and ethinyl estradiol and ferrous fumarate tablets. Lo Loestrin Fe is currently marketed by Warner Chilcott.

On May 16, 2012, Warner Chilcott has filed a patent infringement lawsuit with the US District Court for the District of New Jersey seeking to prevent Watson from commercializing the product prior to the expiration of US Patent Nos 5,552,394 and 7,704,984. Because the lawsuit is filed under the provisions of the Hatch-Waxman Act, the FDA will not be able to approve the ANDA submitted to Watson for up to 30 months from the date Warner Chilcott received the notice of the filed ANDA or until the final resolution is resulved before the court.

The sales of Lo Loestrin Fe in the US in the 12-month ending March 31, 2012 were estimated to be $86M according to IMS Health Data.

Plavix is now a generic medication

The FDA announced that it has approved generic version of Plavix (clopidogrel), a blood thinner indicated to reduce the risk of heart attack and stroke in patients who have had a recent heart attack or a recent stroke, or have partial or total blockage of an artery (peripheral artery disease).

Clopidogrel works by decreasing the platelet formation.

The following companies are now able to market the 300 mg generic version of Plavix: Dr. Reddy's Laboratories, Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals.

Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals and Torrent Pharmaceuticals are now able to market the 75 mg clopidogrel.



Apotex Corporation,