Innovator companies, which have spent millions on the development of branded drugs, often face patent challenges from companies looking to bring in generic versions of the drug prior to the loss of patent exclusivity. In such a scenario, the innovator companies usually file a patent infringement lawsuit against the generic company to delay the entry of generic versions.
A similar step was taken last week by Purdue Pharma which is facing a patent challenge from Actavis plc (ACT). Actavis has submitted an Abbreviated New Drug Application (ANDA) to the FDA for its generic version of Purdue’s Butrans (5 mcg/hr, 10 mcg/hr and 20 mcg/hr). Butrans is approved for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatment options are inadequate.
Purdue has filed a patent infringement lawsuit against Actavis in the U.S. District Court for the District of Delaware in order to prevent Actavis from commercializing its generic version of Butrans prior to the expiration of certain U.S. Patents. With the lawsuit being filed under the provisions of the Hatch-Waxman Act, the FDA cannot grant final approval to Actavis’ generic version for up to 30 months from the date the notice was received by Purdue about the ANDA filing or until final resolution of the matter before the court, whichever occurs first.
Actavis believes it may be the first-to-file an ANDA for a generic version of Butrans and might be entitled to 180 days of generic market exclusivity if the FDA approves the ANDA.
As per IMS Health, Butrans sales in the U.S. were $158 million for the twelve months ended Jul 31, 2014.
We note that several companies including BioDelivery Sciences International, Inc. (BDSI), Mallinckrodt plc (MNK) and Pfizer Inc. (PFE) among others are developing treatments targeting the pain market.
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