Pfizer sues Teva over arthritis treatment

Pfizer has sued  Teva Pharmaceuticals, alleging that the Israeli pharma company is planning on releasing a generic of Pfizer’s Xeljanz XR (Tofacitinib Citrate) arthritis treatment before the branded drug’s key patent expires.

In a complaint filed to the US District Court or the District of Delaware on Friday, February 11, Pfizer accused Teva Pharmaceuticals of infringing one of Xeljanz’s core patents—US patent number 10,639,309.

Pfizer’s Xeljanz contains 22mg of tofacitinib citrate in extended-release tablets which are meant to be taken once a day.

The drug acts as an inhibitor of “Janus kinases” enzymes and is used predominantly to treat adult patients with “moderate to severe” active rheumatoid arthritis who have an intolerance to methotrexate, or any other antirheumatic drugs.

The ‘309 patent, titled Tofacitinib Oral Sustained Release Dosage Forms” is set to expire on March 14, 2034.

Pfizer became aware of the generic following Teva’s filing of an amendment to an Abbreviated New Drug Application (ANDA), which sought approval from the US Food and Drug Administration to manufacture and sell generic 22mg Xeljanz XR.

According to the complaint, Pfizer is seeking a ruling that Teva’s amended ANDA constitutes an act of infringement and requests a permanent injunction barring the release of Teva’s generic before the patent’s expiration, and damages paid.

Teva first notified Pfizer in January 2022 that it had submitted an amendment to its ANDA to the FDA, seeking approval to sell the generic tablets, and that the ‘309 patent was invalid.

The letter also indicates that the generic will contain tofacitinib citrate as the active ingredient.

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