Please login to the form below

Not currently logged in
Email:
Password:

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.

30th July 2007

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Porterhouse Medical Group

The Porterhouse Medical Group provides powerful, insight-driven, scientific and medical communication services to the pharmaceutical industry across the globe, with...

Latest intelligence

COVID-19 is redefining the value of ‘critical jobs’: An opportunity for social care?
...
How to keep your weight under control during lockdown
...
Brands stepping up to show solidarity during COVID-19
The brands that are stepping up to show solidarity during COVID-19 will be those that are remembered long after pandemic passes....

Infographics