GSK agrees generic deal on Malarone
pharmafile | April 13, 2010 | News story | Sales and Marketing | GSK, depression, generics
Generic versions of two GlaxoSmithKline products have received the green light for launch in the US.
Mylan has been given approval for a generic of top selling antidepressant Wellbutrin (bupropion) while Glenmark is to launch its version of GSK’s malaria treatment Malarone (atovaquone/proguanil).
Mylan received final approval from the FDA for bupropion hydrochloride extended-release tablets in 100 mg, 150 mg and 200 mg doses, and has started shipping the product.
Wellbutrin had US sales of approximately $363 million last year, according to IMS Health.
Mylan has another 141 generic drug applications pending FDA approval, 38 of which are potential first-to-file opportunities.
Earlier this month the FDA allowed the company to produce a version of Merck’s hypertension treatment Hyzaar – part of a series of approvals which will see generics of the drug made available for the first time.
Meanwhile the Glenmark announcement follows the settlement of litigation with GSK and under the terms of the agreement its version of Malarone tablets are expected in the second half of next year.
The US subsidiary of Mumbai-based Glenmark will be able to market and distribute the 250mg/100mg dose under a royalty-bearing licence from GSK.
Glenmark says it should have 180 days of exclusivity as the first generic to file a marketing application for the product, which GSK currently markets in the US as a prophylactic and therapeutic treatment for malaria.
Glenmark sells most of its products in the US and Europe. Last year US sales of Malarone were approximately $56 million
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