Friday, 29 February 2008

Teva got final approval to market Irinotecan injection

Teva Pharma announced today that the USFDA has granted final approval for the Company's ANDA to market its generic version of Pfizer's chemotherapy agent, Camptosar(R) (Irinotecan Hydrochloride) Injection, 20 mg/mL. Shipment of this product, available in 40 mg/2 mL and 100 mg/5 mL single dose vials, will begin immediately.
The brand product had annual sales of approximately $556 million in the United States for the twelve months that ended December 31, 2007, based on IMS sales data.

Pfizer to appeal against Atorvastatin enatiomer patent invalidation in Netherlands

Pfizer announced that it will seek to appeal a ruling of the Court of Appeal of The Hague in the Netherlands that Pfizer's Atorvastatin hemicalcium enantiomer patent is invalid. The patent (EP 409281) had been challenged by generics manufacturer Ranbaxy and expires in July 2010.
The decision has no commercial impact because Pfizer's basic patent covering Lipitor (EP 247,633) remains in force and expires in November 2011. Last week, the same court ruled that the basic patent would be infringed by Ranbaxy's proposed generic atorvastatin product. That decision, which is also subject to possible appeal, prevents Ranbaxy from launching a competitor drug before November 2011.
The company pointed out that today's ruling does not affect patent litigation involving Lipitor in other jurisdictions, including the United States. Pfizer said it will continue to vigorously defend its patents against infringement.

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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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