Vardenafil Hydrochloride (Levitra) 2.5 mg, 5 mg, 10mg and 20 mg tablets: Innovator Bayer sued Teva in a bid to block generic version

Innovator Bayer has sued generic player Teva in US district court for the district of Delaware in a bid to block generic version of Vardenafil Hydrochloride (Levitra) 2.5 mg, 5 mg, 10 mg and 20 mg tablets.

Innovator has sued Teva for the infringement of following Orange Book listed patent:

US6362178 (Expiry: Oct 31, 2018): Which covers a method of treating chronic heart failure or erectile dysfunction, comprising administering to a mammal an effective amount of various PDE-V inhibitors like Vardenafil.

Possibly, generic player Teva has filed Paragraph IV certification with invalidation grounds against said patent. As innovator has sued Teva with in 45 days after the receipt of Para IV lettr, accordingly, Teva's ANDA approval process would be delayed by 30 month as per Hatch-Waxman provisions.

Innovator Bayer got approval to market Vardenafil Hydrochloride (Levitra) 2.5 mg, 5 mg, 10mg and 20 mg tablet on Aug 19, 2003. The New Chemical Entity exclusivity of this product has already expired on Aug 19, 2008.