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4 April 2023GenericsLiz Hockley

Abbvie seeks to block copycat of endometriosis drug

Lawsuit is second to be filed in Delaware over Abbvie’s Orilissa treatment | Abbive says Teva’s ANDA infringes patent granted in January.

In its latest move to block generic versions of endometriosis drug Orilissa,  Abbvie is seeking an injunction on a proposed copy of the medication until 2039 off the back of a patent issued in January this year.

Via a lawsuit filed at the US District Court of Delaware yesterday (April 3), Abbvie accused generic manufacturer  Teva Pharmaceuticals of infringing its patent through an Abbreviated New Drug Application (ANDA) to make a generic version of  Orilissa.

Abbvie’s Orilissa dials down estrogen in patients, which can help manage endometriosis pain. It is a gonadotropin-releasing hormone (GnRH) receptor antagonist with an active ingredient of elagolix sodium.

Approved by the US Food and Drug Administration (FDA) in 2019, Orilissa has been prescribed to over 80,000 women, according to the lawsuit, with two doses available (150mg and 200mg) depending on the severity of the pain.

On January 3 this year, the US Patent and Trademark Office (PTO) granted Abbvie US patent number 11,542,239 for “elagolix sodium compositions and processes” related to Orilissa. It is set to expire on July 23, 2039.

According to the suit, Teva sent a letter to Abbvie dated February 17 giving notice of its ANDA, and alleging that the claims of the ‘239 patent are “invalid, unenforceable, and/or would not be infringed by Teva’s generic product”.

Abbvie contests that there is “no substantial non-infringing use for Teva’s product”, and wants a block on FDA approval of the generic until the ‘239 patent has expired.

First suit

In a separate action filed in October last year, Abbvie—along with  Neurocrine Biosciences— is suing Teva and a number of other generic manufacturers for infringing three other patents related to Orilissa.

This was filed in response to a letter from Teva in September giving notice of the same ANDA to make a generic form of the medication, which Abbvie claims infringes US patents nos. 10,537,572, 10,682,351 and 11,344,551.

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