Betting big on Pramipexole Dihydrochloride, the generic version of Boehringer Ingelheim’s Mirapex tablets, Glenmark Generics Ltd, a unit of Glenmark Pharmaceuticals Ltd, is gearing up to take on global generics majors such as Teva, Alembic, Mylan.
Considering that the market for the products estimated to be good, the company, which is likely to launch the generic in September-October 2010, is eyeing rich benefits due to its cost advantage and wide distribution network across the US and Europe.
Similarly, the company is also banking on another product named Atomoxetine Hydrochloride, the generic version of Lilly’s Strattera, which is estimated to have an annual potential of $498 million. The company is expected to launch this product after Pramipexole Dihydrochloride, sources in the know told FE.
Gelenmark Generics Inc, USA (GGI), a subsidiary of Glenmark Generics Ltd on Thursday announced that the US Food and Drug Administration (USFDA) has granted tentative approval for Pramipexole Dihydrochloride tablets. GGI also received USFDA tentative approval for Atomoxetine Hydrochloride capsules.
The tentative approval for Pramipexole Dihydrochloride tablets is for the 0.125 mg, 0.25 mg, 0.5 mg, 1 mg, and 1.5 mg strengths for curing Parkinsons disease. The market size of Pramipexole Dihydrochloride is estimated at $487 million. Atomoxetine Hydrochloride, used in the treatment of attention deficit or hyperactivity disorder, has an estimated market size of $498 million. Glenmark’s tentative approval was granted for the 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg and 100 mg strengths.
Glenmark’s current marketing portfolio consists of 49 products authorised for distribution in the US. The company remains focused on strategic planning and development and continues its aggressive filing schedule for new ANDA submissions.
