Glenmark’s hypertension generic verapamil SR pills receives US FDA approval

Glenmark Generics (GGL), a US subsidiary of Mumbai-India based Glenmark Phamaceuticals, has received approval for its generic version of hypertension drug verapamil extended release tablets from US FDA.

Glenmark 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.

“This approval and launch holds significance for Glenmark Generics as it marks our entry into the extended release segment which is a differentiated and niche segment,” stated Terrance Coughlin, chief executive officer, Glenmark Generics.

Glenmark has also filed a number of ANDAs in the extended Release segment that are pending for approval with the US FDA, Mr Coughlin added.

Glenmark is expected to start marketing verapamil SR on 240 mg in the US market immediately.

Verapamil SR on 240 mg’s approval expands Glenmark’s current portfolio to a total of 49 generic products authorized for distribution in the US market.

Glenmark currently has over 45 ANDA’s filed with the US FDA pending approval.

Glenmark joined hands with Aurobindo in July to launch thier generic versions of hypertension drugs fosinopril sodium and hydrochlorothiazide – the therapeutic equivalent of Bristol-Myers Squibb’s Monopril-HCT – in the US market.

Glenmark Generics Inc., which received the approval from US FDA to market fosinopril sodium and hydrochlorothiazide tablets, will market fosinopril sodium and hydrochlorothiazide (HCTZ) pills in both 10mg/12.5mg and 20mg/12.5mg strengths and are indicated for the treatment of hypertension.

Glenmark’s fosinopril sodium and hydrochlorothiazide pills are the therapeutic equivalent (generic) of Bristol Myers Squibb’s Monopril-HCT.

In August, Glenmark Pharmaceuticals and US partner Forest Laboratories said oglemilast – a drug they were developing to treat chronic obstructive pulmonary disease (COPD) failed in a mid-stage trial COPD has an estimated market worth about $5 billion.

Glenmark and Forest said a Phase IIb study meant to determine the best appropriate dosing for the medicine did not show statistically significant results. Glenmark has two other drugs in mid-stage trials currently in development. One to treat Type II diabetes, and one for osteoarthritic pain, incontinence and neuropathic pain, according to the company’s website.

Glenmark has got first-to-file status for Zetia, with the generic name Ezetimibe, Tarka (Trandolapril + Verapamil) and Cutivate (Fluticasone lotion).

Recently, Glenmark Pharmaceuticals reportedly raised Rs 413 crore ($85 million) from share sale to institutional investors. Glenmark sold 1.87 crore shares to large investors at Rs 221 per share.