Glenmark enters into a settlement and license agreement with Sepracor Inc

US specialty pharmaceutical company Sepracor Inc, owned by Japan's Dainippon Sumitomo Pharma Co since April, and Mumbai-based Generics maker Glenmark   have announced the settlement of their patent dispute over generic Eszopiclone tablets, which Sepracor markets under the brand name Lunesta.

Sepracor entered into a settlement and license agreement with the Glenmark Pharmaceuticals Ltd  and its wholly -owned US subsidiary Glenmark Generics Inc, US, under  which Glenmark would be permitted to launch its generic product after 30 November  2013, or two and one half months prior to the expiry of Sepracor's US Patent 6,444,673, or 30 May 2014 if Sepracor obtains paediatric exclusivity for Lunesta.

The settlement and license agreement and consent judgement and order also would permit Glenmark to launch its generic product earlier under certain circumstances, which the two companies did not disclose.

The court's approval of the proposed consent judgement and order of permanent injunction would dismiss Sepracor Inc and Glenmark's respective claims and defenses without prejudice in the consolidated litigation currently pending against Glenmark and other defendants.

Lunesta is available in 1mg, 2mg and 3mg tablets and is indicated for the treatment of insomnia.

According to IMS Health data for the 12 month period ending March 2010, Lunesta achieved annual sales of USD 741 million and is the second highest selling branded prescription medication in its class.

Glenmark has settled two patent suits this year, one with GlaxoSmithKline (GSK) concerning atovaquone and proguanil hydrochloride tablets, the generic version of GSK's Malarone tablets use in the treatment of malaria in April (See: Glenmark settles malaria drug patent dispute with GlaxoSmithKline) 

And in May, a patent-infringemnt lawsuit with US drug giant Merck & Co for generic version of its Zetia (ezetimibe.) It reached an out of court deal that allowed Glenmark to launch the drug ahead of Merck's patent cover over it expires. (See: Merck settles Zetia patent suit with Glenmark)