Generic pharma giant Ranbaxy has launched generic version of Valacyclovir hydrochloride (Valtrex) 500 mg and 1 g tablets in USA on November 25, 2009.
Earlier, Ranbaxy was the first company who challenged innovator Glaxosmithkline (GSK) following Orange Book listed patent:
US4957924 (Expiry: Dec 23, 2009): Which covers Valacyclovir as product.
Subsequently, innovator sued Ranbaxy in New Jersey District Court in 2003. Afterwards, Ranbaxy got final approval from USFDA for this product on January 31, 2007 .
Further, as per paragraph IV patent litigation settlement agreement in July, 2007 with innovator Glaxosmithkline (GSK), Ranbaxy agreed to enter into the market in later half of 2009. Also, Ranbaxy entered into licensing agreement with innovator on two Orange Book listed patents US5879706 and US6107302 (both patents would expire on Jul 19, 2016), which covers polymorph and formulation of Valacyclovir.
Importantly, Ranbaxy is first Para IV filer for this product; accordingly, Ranbaxy would enjoy financially rewarding 180 days “First To File” market exclusivity.
Ranbaxy has manufactured the Valacyclovir hydrochloride 500 mg and 1 g tablets from it’s New Jersey based subsidiary Ohm Laboratories.
The other generic players who have received tentative approval from USFDA for this product are Dr. Reddy (June 26, 2009), Sandoz (July 30, 2007), Teva (October 4, 2007), Mylan (January 30, 2007), Watson (January 18, 2007). The other generic players would be able to launch their generic version after the expiry of 180 days exclusivity of Ranbaxy.
Valacyclovir tablets (Valtrex) 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, and suppression of genital herpes in immunocopetent and HIV-infected individuals, reduction of risk of heterosexual transmission of genital herpes.
As per investment research firm IMS, the annual USA sales for Valacyclovir tablets 500 mg and 1 g is about 2.2 billion dollars.
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