Sean Pavone / (US District Court for the District of Massachusetts)
1 April 2015Americas

Purdue moves to block oxycodone drug

Purdue Pharma has sued Collegium Pharmaceutical for allegedly infringing four of its patents relating to extended release painkiller OxyContin (oxycodone).

Purdue filed the lawsuit at the US District Court for the District of Massachusetts on Thursday (March 26), after Collegium sent a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval to make and sell its Xtampza ER product.

Xtampza is an oxycodone extended release capsule in 9mg, 13.5mg, 18mg, 27mg and 36mg strengths.

Collegium included a Paragraph IV certification in its NDA, alleging that the three active ingredient-related patents are invalid, unenforceable, and will not be infringed by the Xtampza product.

Three of the patents asserted in the suit, US numbers 7,674,799; 7,674,800; and 7,683,072, are related to OxyContin’s active ingredient, dosage forms including the active ingredient, and processes for making the drug. They are due to expire in March 2025.

According to the complaint, the three patents had been invalidated in another lawsuit that did not involve Collegium. An appeal is pending.

The fourth patent, US number 8,652,497, protects an “abuse-deterrent feature” of OxyContin.

The Orange Book, a list of FDA-approved pharmaceutical products and their associated patents, lists OxyContin in seven different strengths: 10mg, 15mg, 20mg, 30mg, 40mg, 60mg, and 80mg.

Purdue said that while Xtampza does not include oxycodone hydrochloride salt, it does include a different salt, oxycodone myristate, which is equivalent to oxycodone hydrochloride.

According to the complaint, Purdue has asked for judgment that Collegium’s actions were an act of infringement, that if the FDA is to approve Collegium’s product it does not do so until after the patents have expired, and for an injunction stopping Collegium from making and selling drugs that infringe the patents.

On March 24, Purdue filed a similar complaint at the US District Court for the District of Delaware. It said it would dismiss the Massachusetts action if Collegium does not challenge, or is unsuccessful in challenging jurisdiction and venue in Delaware.

Collegium did not respond to a request for comment.

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