Paraplatin "Authorized" Generic To Be Launched By Teva
This article was originally published in The Pink Sheet Daily
Executive Summary
Bristol's chemotherapeutic agent is expected to have pediatric exclusivity through mid-October, but Teva's version will come to market in June.
You may also be interested in...
Lamictal Patent Settlement Allows Teva To Launch Chewable Generic By July
Litigation settlement with GlaxoSmithKline will allow Teva to enter the market with a chewable generic more than three years before a Lamictal use patent in epilepsy expires. Teva also can market regular lamotrigine tablets "with an expected launch date in 2008" under the settlement.
Lamictal Patent Settlement Allows Teva To Launch Chewable Generic By July
Litigation settlement with GlaxoSmithKline will allow Teva to enter the market with a chewable generic more than three years before a Lamictal use patent in epilepsy expires. Teva also can market regular lamotrigine tablets "with an expected launch date in 2008" under the settlement.
Paraplatin Pediatric Exclusivity Ends
Multiple ANDAs for Bristol-Myers Squibb's Paraplatin (carboplatin) were approved Oct. 14, marking the end of pediatric exclusivity as well as Teva's sole-generic status. Teva has been distributing an "authorized" generic under a patent suit settlement (1"The Pink Sheet" DAILY, April 27, 2004). Generics from Bedford, Pharmachemie, American Pharmaceutical Partners and Mayne were approved; ANDAs from Gensia Sicor and Faulding are tentatively approved