Glenmark, Aurobindo to market fosinopril-hydrochlorothiazide (Monopril-HCT) generic pills for hypertension in US

India’s Glenmark and Aurobindo are set 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., USA (GGI), the US subsidiary of Glenmark has received the approval from US FDA to market fosinopril sodium and hydrochlorothiazide tablets in the U.S. market.

Glenmark 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.

Generic market sales for fosinopril sodium and hydrochlorothiazide is approximately USD 10 million for the 12 month period ending March 2009, according to IMS Health Data.

Glenmark is prepared to commence shipping based on the final approval from the U.S. FDA. for fosinopril + HCTZ is a maintenance medication, said Terrance Coughlin, Chief Executive Officer, Glenmark Generics Limited in an official press communique.

Mumbai-based Glenmark worked closely with InvaGen Pharmaceuticals Inc. (InvaGen) for the the Abbreviated New Drug Application (ANDA) – the application filed with US FDA for generic approval– for fosinopril sodium and hydrochlorothiazide tablets.

Glenmark will exclusively market and distribute the product in US while InvaGen will be responsible for their manufacture and supply. All development, regulatory costs and profits on fosinopril sodium and hydrochlorothiazide tablets’ sale in the U.S. will be shared equally between Glenmark and Invagen, the release said.

Glenmark and InvaGen entered into a collaboration agreement for the joint development, filing and marketing of several generic pharmaceutical products for the U.S. market. The product list included a mixture of off-patent and patent-protected molecules in the year 2006.

Fosinopril sodium and hydrochlorothiazide (HCTZ) approval expands Glenmark’s portfolio to 46 generic products authorized for distribution in the US market.

Glenmark has has over 40 ANDAs pending approval with the US FDA.

In June, Glenmark Generics received ANDA approval from the US FDA for alclometasone dipropionate cream 0.05%. Alclometasone dipropionate – generic equivalent of GSK’s Aclovate cream -is a low to medium potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Glenmark Generics Limited (GGL) has an established presence in North America, EU and Argentina and maintains marketing front-ends in these countries. GGL maintains a strong base in formulations development with laboratories in India and Latin America. Glenmark has a state-ofthe-art manufacturing plant at Goa, India that is approved by US FDA, TPD (Canada), MHRA, UK etc.

GGL also markets over 45 APIs to more than 80 countries across the world and has over 30 USDMFs approved along with several Canadian DMFs, EDMFs and CEPs/CoSs.

Glenmark Pharmaceuticals Ltd, headquartered at Mumbai, India, has operations over 85 countries. Glenmark has discovery pipeline of new molecules and is focused in the areas of inflammation [asthma/COPD, etc.], and metabolic disorders [diabetes, obesity, etc.].

Hyderabad, south India based Aurobindo is another Indian generic major which received US FDA approval for Fosinopril sodium-hydrochlorothiazide combination pills.

Aurobindo is a leader in active pharmaceutical ingredients. Aurobindo’s product portfolio is spread over six therapeutic/product areas encompassing antibiotics, anti- retrovirals, CVS, CNS, gastroenterologicals, and anti-allergics.

Fosinopril sodium-hydrochlorothiazide combination is used to treat high blood pressure. It usually is prescribed after other blood pressure medications have failed. Fosinopril sodium is an ACE (angiotensin-converting enzyme) inhibitor. Fosinopril works by preventing a chemical in your blood called angiotensin I from converting into a more potent form (angiotensin II) that increases salt and water retention in your body and causes blood vessels to constrict—two actions that tend to increase blood pressure.Hydrochlorothiazide, a diuretic that promotes the production of urine.