Wockhardt may get rights for two Parkinson's drugs

Settles 3 patent infringement cases out of court.

Wockhardt today said it had reached an out-of-court settlement on three patent infringement cases in the US with Orion Corporation. The dispute related to two of Parkinson’s disease drug brands, Comtan and Stalevo.

Under the agreement, Wockhardt will be able to launch generic versions of Comtan and Stalevo on September 30, 2012, possibly even earlier. Wockhardt is the first generic challenger of Comtan and Stavelo patents and is eligible for 180 days marketing exclusivity upon launch.

According to data from drug sales tracking agency IMS, annual sales of Comtan and Stalevo products in the US were $87 million and $113 million, respectively, as of December 2008.

 

The agreement is subject to review by the US Department of Justice and the Federal Trade Commission, according to a press release.

According to US rules for selling generic drugs, the generic company which successfully challenges the drug patent of an innovator company gets 180 days exclusive selling rights after the expiry of the patent.

The challenger has to sue the generic player within 45 days to prevent the US drug regulator, the Food and Drug Administration, from allowing the marketing application for the next 30 months.

Orion filed the first lawsuit in the US in 2007. Thereafter, two additional lawsuits were filed in 2008.

Comtan is used in treatment of Parkinson’s disease as an adjunct treatment for patients treated with drugs levodopa and carbidopa. Stalevo is a combination of carbidopa, levodopa and entacapone for treatment of Parkinson’s disease. Both products contain entacapone, an enzyme-inhibiting agent.

Out of court settlements are common in generic drug business. Last year, Pfizer and Ranbaxy settled their dispute over Lipitor, the world’s largest selling drug with annual sales of over $13 billion.