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9 September 2021AmericasAlex Baldwin

Pfizer to settle Xeljanz suit with Teva

Pfizer has asked a Delaware court to drop an infringement lawsuit against Teva Pharmaceuticals over a proposed generic of its rheumatoid arthritis drug Xeljanz (tofacitinib).

Pfizer submitted the stipulation of dismissal to the US District Court for the District of Delaware on Tuesday, September 7, requesting that all claims and counterclaims be dismissed without prejudice, but to keep any protective orders entered by the court in place.

Teva had filed an Abbreviated New Drug Application (ANDA) with the Food and Drug Administration (FDA), notifying Pfizer in October 2018 that it planned to manufacture a generic version of Xeljanz prior to the expiration of the key patent US 9,937,181.

The ‘181 patent was issued in April 2018, titled “Tofacitinib Oral Sustained Release Dosage Forms” and is set to expire in March 2034.

The FDA’s orange book also features four additional patents related to the drug which are not at issue.

The trial for the case had been originally been proposed for January  3, 2022, according to a motion to amend the case schedule.

Xeljanz litigation

Alongside its litigation with Teva, Pfizer had also sued Aurobindo for submitting an ANDA for a Xeljanz generic in January 2021, claiming it had infringed two other patents related to the drug US 6,965,027 and reissue patent RE41,783.

Pfizer also launched similar litigation against Zydus Pharmaceuticals in February 2021, claiming that Zydus had infringed on the same two patents with its proposed Xeljanz generic.

Both cases are still pending before the Delaware court.

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20 April 2021   Pfizer has settled lawsuits against two Indian generics makers who had informed the US Food and Drug Administration of plans to launch their own version of Xeljanz XR.
Americas
4 July 2014   Pfizer has launched a lawsuit against Aurobindo Pharma accusing the Indian pharmaceutical company of infringing patents related to an antibiotic used to treat skin infections.

More on this story

Big Pharma
20 April 2021   Pfizer has settled lawsuits against two Indian generics makers who had informed the US Food and Drug Administration of plans to launch their own version of Xeljanz XR.
Americas
4 July 2014   Pfizer has launched a lawsuit against Aurobindo Pharma accusing the Indian pharmaceutical company of infringing patents related to an antibiotic used to treat skin infections.