Please login to the form below
Ranbaxy and GSK agree to settle on US valacyclovir patent
Ranbaxy reaches an agreement with GSK to dismiss its US litigation with regard to anti-infective Valtrex
India-headquartered Ranbaxy has reached an agreement with GlaxoSmithKline (GSK) to dismiss its US litigation with regard to anti-infective, Valtrex (valacyclovir).
The US lawsuit was related to GSK's US Patent 4,957,924, covering valacyclovir and its use in the treatment of herpes simplex infection.
Per the agreement, Ranbaxy will enter the US market in late 2009 as the first generic version of valacyclovir and company will benefit from a 180-day exclusivity arrangement. Ranbaxy received a final approval from the FDA to market and manufacture valacyclovir tablets in February 2007.
Ranbaxy has also obtained a license to GSK's US Patents 5,879,706 and 6,107,302, listed in the Orange Book for valacyclovir. The total annual market sales of Valtrex were approximately USD 1.3bn, according to IMS MIDAS data.
Ranbaxy says it has a First-to File (FTF) status on around 20 Para IV ANDA filings, which at current ethical prices could offer a potential market size of USD 26bn.
Share
Related Hub content
Subscribe to our email news alerts
- Actinic keratosis – a common skin condition that can lead to skin cancer
- The paper trail
- Medscape Education’s Large Presence at IDWeek 2023
- WHO recommends second malaria vaccine for children
- Sanofi enters agreement with Janssen to develop E. coli vaccine candidate
- NFID and CDC urge US adults to get vaccinated against flu and COVID-19
No results were found
Latest intelligence
- Actinic keratosis – a common skin condition that can lead to skin cancer
- PMGroup talks to Volker Koscielny, Chief Medical Officer at Almirall, about the importance of remaining vigilant about skin checks, the prevalence of actinic keratosis in the UK and the steps...
- Man vs microbe: the fight against antimicrobial resistance
- How the emerging resistance to antibiotics is being exacerbated by a lack of research and development into new antibiotics...
- Is trust the key factor in digital HCP engagement? New whitepaper from Graphite Digital
- Based on research with HCPs in the UK, USA and France, Graphite Digital’s latest whitepaper sheds light on HCP perceptions of pharma-owned digital channels, and what organisations should be prioritising...
