Innovator Novartis sued Roxane pharma for the Infringement of orange book listed patent US5246937 on Famvir® (famciclovir) following change in certification as part of Roxane's filing of an ANDA. Earlier, CAFC has invalidated the same patent on complaint from Teva. After the invalidation of ‘937 patent Roxane has changed its certification from Para III to Para IV (Earlier Roxane filed Para III against said patent). Also, Roxane was sued on method of use patents lised in orange book. The above lawsuit is second against Roxane for the said product.
Following patents are listed in orange book for this product
US5246937 (Expiry: Sep 21, 2010)- which covers purine derivatives like Famciclovir as product
US5840763 (Expiry: Sep 1, 2015)- Method of use for herpes viral infection
US5866581 (Expiry: Oct 4, 2014)- Method of use for post-herpetic neuralgia
US5916893 (Expiry: Sep 1, 2015)- Method of use for latent infection of herpesviruses
US6124304 (Expiry: Oct 4, 2014)- method of use for the treatment of zoster associated pain
Teva has approved ANDA for 125 mg, 250 mg and 500 mg tablets, the ANDA was approved on August 24, 2007. (Link to earlier news from IPPHARMADOC)
Teva has approved ANDA for 125 mg, 250 mg and 500 mg tablets, the ANDA was approved on August 24, 2007. (Link to earlier news from IPPHARMADOC)
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