Hyderabad based generic player Dr. Reddy's Laboratories has received tentative approval on June 26, 2009 from the USFDA on generic Valacyclovir hydrochloride (Valtrex) 500 mg and 1 g tablets. The product patent US4957924 will expire on Dec 23, 2009. Also, innovator has listed two additional patents in Orange Book for this product US5879706 and US6107302 (both patents will expire on Jul 19, 2016), which cover polymorph and formulation of Valacyclovir.
The generic player Ranbaxy have got final approval for this product on January 31, 2007, however, as per licensing agreement with innovator Glaxosmithkline (GSK), Ranbaxy will enter into the market in later half of 2009. Importantly, Ranbaxy is first Para IV filer for this product.
The other generic players who have received tentative approval from USFDA for this product are Sandoz (July 30, 2007), Teva (October 4, 2007), Mylan (January 30, 2007), Watson (January 18, 2007). The other generic players may launch their product after the expiry of 180 days exclusivity of Ranbaxy.
Valacyclovir tablets 500 mg and 1 g were approved by USFDA on Jun 23, 1995 and are indicated for the treatment of herpes zoster, treatment of genital herpes, treatment of cold sores, suppression of genital herpes in immunocopetent and HIV-infected individuals, reduction of risk of heterosexual transmission of genital herpes
Generic update
The generic player Apotex has filed a complaint in the U.S. District Court for the Middle District of North Carolina for declaratory judgment of non-infringement for Valacyclovir Tablets.
As per complaint, Apotex argues that due to Ranbaxy’s cGMP problems, a DJ action is necessary to remove the hurdles for subsequent ANDA filers. Ranbaxy is first para IV filer for this product. Apotex's action is aimed at triggering the 180 days exclusivity of Ranbaxy.
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