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Glenmark gets a booster dose from pramipexole (Mirapex) and atomoxetine (Strattera) generic approvals in US

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Thursday, December 24, 2009, 18:21 This news item was posted in Industry category and has 0 Comments so far.

Glenmark Generics Inc. USA has received tentative approvals for generic versions of pramipexole and atomoxetine pills from the US FDA.

Glenmark Generics’ pramipexole dihydrochloride tablets is the generic version of Boehringer Ingelheim’s Mirapex tablets used in the treatment of Parkinson’s disease and restless legs syndrome.

Pramipexole dihydrochloride tablets generated sales of USD 487 million for the 12 month period ending September 2009, according to IMS Health.

US FDA granted tentative approval for pramipexole dihydrochloride tablets in strengths 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg strengths.

While atomoxetine hydrochloride capsules are the generic version of Lilly’s Strattera.

Glenmark received tentative approvals for atomixetine hydrochloride pills in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths.

Atomoxetine Hydrochloride capsules is indicated for the treatment of attention-deficit/hyperactivity disorder (ADHD) and generated USD 498 million in sales for the 12 month period ended September 2009, according to IMS Health.

Glenmark’s tentative approval was granted for the Abbreviated New Drug Applications (ANDA) of 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths.

Glenmark Generics plans to launch pramipexole dihydrochloride tablets in October 2010 or even earlier in certain circumstances based on the full approval from US FDA.

Glenmark Generics has received ten final and five tentative approvals this calendar year and has well over 40 ANDAs pending approval with the U.S. FDA.

Glenmark Generic’s current marketing portfolio consists of 49 products authorized for distribution in the United States.

Glenmark Generics Limited (GGL) is a subsidiary of Glenmark Pharmaceuticals Limited (Glenmark). GGL has presence in North America, EU and Argentina and maintains marketing front-ends in these countries. It 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.

In October, Glenmark Generics (Europe) Ltd launched its topiramate, nebivolvol, mometasone and perindopril generic versions in UK market.

Glenmark’s anticonvulsant drug topiramate is the generic of Ortho-McNeil Neurologics and Noramco, Inc – divisions of Johnson & Johnson –brand name drug Topamax.

Topiramate has market size of Euro 21 million, according to IMS Health.

Glenmark Generic launched anti-hypertensive drug nebivolol 5mg tablets. Nebivolvol has a market size of Euro 6.8 million. Mylan Laboratories licensed the U.S. and Canadian rights to nebivolol from Janssen Pharmaceutica N.V. in 2001.

Glenmark Generic introduced blood pressure drug perindopril tablets in three strengths – 2mg, 4mg, 8mg -in UK market. peridopril has a market size of Euro 88 million.

Glenmark is the only company marketing the generic mometasone ointment product in the UK market while for perindopril, the launch is an addition to third party business existing since last year when the product was launched, the company informed in a press release.

Glenmark Generic has been launching the products for the first time in its own livery in the UK.

All these products will be sold directly by the UK subsidiary and through it’s own front end.

Glenmark Pharmaceuticals Ltd has eight molecules in various stages of clinical development and is primarily focused in the areas of inflammation (asthma/COPD, rheumatoid arthritis etc.), metabolic disorders (diabetes, obesity, etc.) and neuropathic pain and inflammatory pain.

Glenmark has a significant presence in branded generics markets across emerging economies including India.

Glenmark Pharma, along with its subsidiary has twelve manufacturing facilities in four countries and has five R&D centres.

Glenmark is planning to launch an initial public offering or sell shares of Glenmark Generics Ltd. to private equity firms to minimise the huge debt burden by the end of March, Glenmark’s chief executive officer Glenn Saldanha was quoted as saying in recent reports.

Glenmark has already initiated proceeding to list Glenmark Generics in Indian bourses.

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