Glenmark Generics Ltd has 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.
US Food and Drug Administration gave approvals for ropinirole hydrochloride tablets of 0.25 milligram, 0.5 mg, 1 mg, 2 mg, 3 mg , 4 mg and 5 mg strengths.
Glenmark will start selling ropinirole generic pills immediately, the company said in a statement.
Ropinirole hydrochloride tablets reported $104 million in U.S. sales for the 12 months ending December 2009, according to IMS Health.
In January, Glenmark Generics Inc was granted tentative approval for its generic trandolapril and verapamil hydrochloride extended-release tablets from the US FDA.
Glenmark’s trandolapril and verapamil hydrochloride extended-release tablets is the generic version of Abbott’s Tarka tablets.
Tarka tablets achieved sales of USD 64 million for the 12-month period ending September 2009, according to IMS.
Glenmark may get final approval for generic trandolapril and verapamil ANDA from the U.S. FDA after resolving of the litigation currently pending in the US District Court for the District of New Jersey.
In September, Glenmark Generics received approvals for its abbreviated new drug application (ANDA) for verapamil 240mg
strength extended release tablets from US FDA.
Glenmark’s verapamil 240mg extended release tablet is the generic equivalent of Knoll Pharma’s Isoptin SR tablets.
Verapamil, a calcium channel blocker used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders, is also sold under the brand names Calan, Calan SR, Covera-HS, Verelan, Verelan PM.
Verapamil SR on 240 mg strength has more than half the market share of the overall Verapamil SR product line. Total sales for the twelve month period ending June 2009 was USD 65 million, as per IMS Health.
Glenmark’s current marketing portfolio consists of 49 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 Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark).
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.