FTC files complaint against Endo for blocking generics of its pain drugs

pharmafile | April 1, 2016 | News story | Business Services, Manufacturing and Production, Medical Communications, Sales and Marketing Endo International, FTC, legal, regulation 

The US Federal Trade Commission (FTC) has filed a complaint against Endo International (Nasdaq: ENDP) alleging the company used illegal pay-for-delay agreements to block generic competition for its pain drugs.

The complaint says the company paid hundreds of millions of dollars to Impax Laboratories and Allergan’s Watson Laboratories to stall generic versions of its drugs Opana ER (oxymorphone) and Lidoderm (lidocaine).

Under the pay-for-delay deal generics makers agree to drop or hold off patent applications against branded drugs thereby keeping away from launching cheaper versions of the therapy till a certain period in exchange for payments makers of branded drugs.

The FTC has estimated the drugs accounted for 64% of the company’s revenue in 2009. The agency said Endo was aware sales of the corresponding branded product would be impacted by generic competition and that any delay competition would lead to profits even though it will be very costly for consumers.

Shares in Endo dropped as much as 7% Thursday following the news.

According to the complaint, which follows a similar class-action lawsuit, Endo and Impax allegedly entered an illegal agreement in 2010 under which Endo would hold off selling an authorised generic version of Opana ER until January 2013.

Further, Endo also paid Impax more than $112 million as part of a development and co-promotion agreement signed during the same time period, the agency said. US sales of Opana ER stood over $250 million in 2010.

Endo said both agreements were supportive of a competitive environment because they allowed the launch of the generic drugs before the expiration date of its patents adding that it is disappointed by the FTC’s decision to initiate litigation.

Because the settlements complied with all applicable laws, we believe the FTC’s case is without merit, and Endo intends to vigorously defend itself in the litigation, the company said in a statement.

Shares in Endo closed down over a percent to $28.15 Thursday on the Nasdaq.

Anjali Shukla

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