26 February 2013Patents

FDA approves generic heroin substitutes

The US Food and Drug Administration (FDA) has approved two generic versions of Reckitt Benckiser’s heroin replacement tablet Suboxone – despite Reckitt’s claims that the product is unsafe.

Suboxone is the most commonly prescribed opiate addiction treatment in the US. In 2012, it had sales of $625 million and accounted for 20 percent of Reckitt’s operating profits.

Reckitt obtained the US rights to the product in 2002 but has been battling generic competition since its orphan drug status expired in October 2009.

In September 2012, the company announced it was withdrawing Suboxone tablets from sale over concerns that they could be accidentally taken by children and filed a petition urging practitioners to switch to its follow-up product, Suboxone Film. Suboxone Film retains its patent until 2022 and dispenses one dose at a time through a strip of film placed under the tongue.

The company also asked the FDA to deny any applications for generic versions of Suboxone without unit-dose packaging.

The FDA rejected this petition. In a letter dated Friday, 22 February, it said there is no evidence to suggest banning products that don’t use unit doses would reduce accidental poisoning. The FDA also said that regulatory controls already in place for Suboxone are adequate.

“While Reckitt has declared its intention to withdraw Suboxone tablets from sale in the future, our understanding is that this product continues to be shipped and sold … Reckitt’s own actions undermine…its claims with respect to the severity of this safety issue,” the letter added.

The approved generic versions of Suboxone will be sold by New Jersey pharmaceutical companies Amneal and Activis.

In a statement released on Monday, 25 February, Chirag Patel, president and co-chairman of Amneal, said: “The FDA’s decision to approve the first generic equivalents to Suboxone tablets will ensure that millions of patients in the US ... now have access to a high quality, low cost generic version.”

Chintu Patel, CEO of Amneal, added: “We appreciate the FDA’s thorough assessment of Reckitt’s Citizen’s Petition and applaud their recent decision to deny it in its entirety. The FDA determined that Reckitt’s petition did not raise valid scientific or regulatory issues associated with the product, which Amneal contended in its comments on the petition. Physicians should have no concerns in writing prescriptions for the generic tablet form of the product.”

Amneal confirmed that its generic could be available at pharmacies by early March. In a statement released on Monday, Activis said it intends to begin shipping the product immediately.

Reckitt Benckiser said in a statement that it is disappointed with the FDA’s decision but will not be reintroducing Suboxone tablets. Share prices of the company fell by more than four percent following its announcement.

Adam Samansky, partner at Edwards Wildman Palmer LLP in Boston, said: “Innovator pharmaceutical companies are continually trying to bring new products to market that address unmet needs and drive value for the company’s shareholders.

“In today’s litigious climate, and even where a new product presents a clear clinical benefit, generic competitors…routinely accuse innovators of anticompetitive behaviour when the innovator then seeks to withdraw an old product.

“In this case however, while the FDA specifically noted that the Commenter-generics’ allegation of an alleged intent by RB to ‘delay approval of generic versions of its products’ under 505(q)(1)(E) was not a basis for the agency’s denial of RB’s Petition, [it] referred allegations of anticompetitive business practices to the Federal Trade Commission,” he added.

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