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.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
Already registered?
Login to your account
If you don't have a login or your access has expired, you will need to purchase a subscription to gain access to this article, including all our online content.
For more information on individual annual subscriptions for full paid access and corporate subscription options please contact us.
To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.
For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk