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Home Industry News Orion reports on generic entacapone application

Orion reports on generic entacapone application

14th August 2007

Orion has reported that a company has filed an application for marketing authorisation for a generic form of Parkinson’s disease treatment entacapone in 200 mg tablets.

The compound is the active ingredient in the firm’s own Comtan, which is marketed exclusively in the US by its partner Novartis.

Orion notes that in its application, the generics manufacturer has challenged three of the firm’s five patents in the US covering Comtan, with the filing of Paragraph IV certifications, which the company states is not uncommon in the US.

“At this point, the [abbreviated new drug application] review process is just beginning and the realisation of generic competition is neither certain nor imminent,” the firm reports.

It adds that it is currently assessing its options to protect its legal rights, with a 30-month stay of final US Food and Drug Administration (FDA) approval if the firm brings a lawsuit against the generics manufacturer.

During this 30-month period, FDA can only give cautious approval to the applying firm, unless the firm receives decisions in its favour on all patents covered by the lawsuit.

In November 2006, Orion reported the results of a positive quality of life study involving early-phase Parkinson’s disease patients administered with Stavelo, a combination of levodopa, carbidopa and entacapone.

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