Wednesday 7 December 2011

Atorvastatin+Amlodipine (Caudet): Ranbaxy launched authorized generic

The generic player Ranbaxy has launched the authorized generic version of Amlodipine+ Atorvastatin (Caudet) tablets in US market. This was confirmed by the generic pharma giant in following press release: http://www.ranbaxy.com/news/newsdisp.aspx?cp=988&flag=LN

Innovator Pfizer is currently marketing about 11 combination strenghts in US market (Amlodipine+Atorvastatin):

10+10, 10+20, 10+40, 10+80, 2.5+10, 2.5+20, 2.5+40, 5+10, 5+20, 5+40, 5+80 mg tablets

This launch was as per Ranbaxy's earlier settlement with innovator Pfizer. Earlier, Ranbaxy has challenged the innovator's combination patent on this combination US6455574, scheduled to expire on Aug 11, 2018.

Wednesday 30 November 2011

Atorvastatin: Authorized generic arrived, Ranbaxy generic approved with help from Teva

The historic day for American public to welcome generic version of Blockbuster drug Atorvastatin hemicalcium tablets (Lipitor). In India, every person working in the Pharma industry was eagerly awaiting news about generic approval and launch by Ranbaxy. However, it was not clear that Ranbaxy would be able to launch the generic version till Nov 30 evening. However, Dec 1 morning in India bring good news for Ranbaxy and it was confirmed that Ranbaxy has been able to resolve the cGMP issues raised by USFDA against Ranbaxy's API and formulation manufacturing units located in India. The various news items confirmed that Ranbaxy has been able to get the approval from it's US subsidiary M/S Ohm lab. Earlier, some FTF products of Ranbaxy like Donepezil and Valacyclovir were launched from this facility only.


Launch with help from Teva: As per Ranbaxy's official press release the part of sale shall be shared with Teva which probably has helped Ranbaxy on resolving various technical issues with USFDA.
http://www.ranbaxy.com/news/newsdisp.aspx?cp=987&flag=LN

Other generic players: Earlier, the generic players like Actavis, Teva, Dr Reddy, Aurbindo, Mylan and few others have settled the patent litigation with innovator on crystalline form I patent and these companies have been eagerly awaiting the generic launch of Ranbaxy to subsequently launch their generic version after the expiry of 180 days exclusivity of Ranbaxy. These companies are expected to launch the generic version in first week of June, 2012.

Overall, this is a very good news for all the scientists of Ranbaxy who were instrumental in developing the generic version. As the Para IV filing was made about 8-10 years ago and some of those scientists may have been working in other organisations now. However, they will be very happy on this news and must be silently admiring this news.

Overall, a good finish in the end like a bollywood thriller.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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