Insight journal - Dealtalk

Ranbaxy retains exclusivity for Diovan

Posted on 20 January 2014

Tags: ,

Indian pharma major  Ranbaxy is likely to announce a tie-up with a multinational company for sourcing active pharmaceutical ingredient (API) for its blood pressure drug- Diovan.

Ranbaxy enjoys a first-to-file (FTF) status over Diovan since it was off-patented in September 2012. This means they will get six months of marketing exclusivity in the market.

The company, however, hasn’t yet got a final approval from the US-FDA due to all the quality control issues that crept up at its various manufacturing plants in India. Three of their plants are under an import alert in India and the fourth one, Toansa, where they manufactured APIs has also received a Form 483 from US-FDA with certain serious observations on deviations on manufacturing compliance norms. There have been numerous manufacturing and quality compliance issues at Ranbaxy and that’s the key reason why the approval for

Diovan has been stuck for all this while. Diovon is a USD 1.5 billion hypertension drug for the US market and if Ranbaxy can materialize this, it would - analysts say - amount to about USD 200 million kind of revenue stream for Ranbaxy in the FTF period.

Click here to view the article.

For further deal information visit Current Agreements (subscription required)

 

Related

Browse: Complete Current Partnering report catalog

View: Current Partnering’s Partnering Scorecard – view top life science partnering deals by value

View: Current Partnering’s Deal Metrics – the latest deal trend infographics for life science deal making

View: Current Partnering’s Big Pharma Deal Making Scorecard – latest trends in big pharma deal making activity

View: Current Partnering’s Big Biotech Deal Making Scorecard – latest trends in big biotech deal making activity

Signup: Current Partnering Dealmakers Update – weekly newsletter providing the latest life science industry deal news, deal making trends, partnering events – sign up now

Signup: Current Agreements Deals Review – monthly newsletter - reviewing the previous month’s life science deal making – partnering, M&A and financing – sign up now

Subscribe: Current Agreements life sciences partnering, M&A and financing deals database – find out more

Follow us on: LinkedIn Current Partnering | LinkedIn Business Development Network | @Currentpartner on Twitter

Print Friendly, PDF & Email

Leave a Reply