Glenmark to launch norethindrone (Nor-QD) generic contraceptive pill in US shortly

Glenmark has been granted approval for generic contraceptive pill norethindrone tablets 0.35mg by the United States Food and Drug Administration (US FDA).

Glenmark’s norethindrone tablets 0.35mg is the generic version of Nor-QD.

Norethindrone tablets are a progestin-only oral contraceptive indicated for the prevention of pregnancy.

Glenmark will be market norethindrone pills under the trade name Heather and distribution is expected to start immediately, the company said in a press release.

“This is a milestone in the evolving history of Glenmark Generics. Heather represents our first launch of an oral contraceptive in the United States and the first FDA approval on a product out of our hormone facility located in Goa, India,” stated Terrance Coughlin, CEO, Glenmark Generics Limited.

The US contraceptive market has sales reaching USD 4.5 billion in the 12 month period ending December 2009, according to MIDAS sales data, IMS Health.

Total sales of this niche generic contraceptive product were USD 38 million for the 12 month period ending December 2009, according to IMS Health.

Glenmark Generics Inc., USA , the United States subsidiary of Glenmark Generics Limited  recently announced that it has settled litigation pending between Glenmark and GlaxoSmithKline LLC over patent actions concerning Malarone.

Malarone is the combination pill containing atovaquone and proguanil hydrochloride in 250mg/100mg strengths.

Under the terms of the settlement agreements which are still subject to review by the Federal Trade Commission and the Department of Justice, Glenmark will be able to market and distribute its atovaquone / proguanil 250mg/100mg tablets under a royalty-bearing license from GSK in the 3rd quarter of calendar year 2011, or earlier under certain circumstances.

In 2009, GlaxoSmithKline PLC hit Glenmark Generics Inc. USA with a patent infringement suit over its application to manufacture and market a generic version of malaria prophylactic Malarone.

GSK currently markets its product as Malarone in the United States, indicated for the prevention and treatment of malaria.

Recently, Glenmark has been granted generic moexipril pills to treat blood pressure, by Glenmark, have been granted marketing approval in US.

Moexipril HCl is the generic equivalent of Univasc tablets, marketed by Schwarz.

Moexipril is indicated for the treatment of patients with hypertension. The drug clocked total sales of over USD 9 million for the 12 month period ending December 2009, according to IMS Health.

The U.S. Food and Drug Administration has granted approvals for abbreviated new drug application (ANDA) for moexipril hydrocholoride tablets in 7.5mg and 15 mg strengths, Glenmark Generics Inc., USA, the US subsidiary of Indian generic firm Glenmark announced in a press release.

In March, Glenmark had received ANDA approval on moexipril hydrochloride and hydrochlorothiazide tablets which was the generic version of Schwarz Pharmaceuticals’ Uniretic.

Within the previous six weeks, Glenmark has received final ANDA approvals for ropinirole HCl tablets, moexipril HCl & Hydrochlorothiazide tablets and calcipotriene Ointment 0.005%.

Most recently, Glenmark received final approval for generic calcipotriene (Dovonex) ointment 0.005%, from the US FDA.

Calcipotriene ointment is indicated for the treatment of plaque psoriasis in adults.

Calcipotriene ointment was marketed by Leo Pharmaceuticals as Dovonex ointment from its approval in December 1993 through April 2007, when the product was discontinued due to commercial viability.

In March Glenmark Generics Ltd won approval for the sale of generic ropinirole tablets in US.

Glenmark’s ropinirole hydrochloride is a generic equivalent of GlaxoSmithKline’s Requip tablets.

Requip is indicated for treatment of the signs and symptoms of idiopathic Parkinson’s disease as well as the treatment of moderate to severe primary restless leg syndrome.

Ropinirole hydrochloride tablets reported $104 million in U.S. sales for the 12 months ending December 2009, according to IMS Health.

Glenmark’s current marketing portfolio consists of over 50 products authorized for distribution in the United States and it has nearly 50 ANDAs in various stages of the approval process with the U.S. FDA.

Glenmark Generics has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries. The company primarily sells its FDF products in the United States and the European Union, as well as its oncology FDF products in South America.

Glenmark Generics supplies APIs to customers in approximately 65 countries, including the US, various countries in the EU, South America and India. Headquartered at Mumbai, India, has twelve manufacturing facilities in four countries and has five R&D centres.