Pfizer sues MSN Labs over Xeljanz generic
Pfizer has sued MSN Laboratories to prevent the rollout of generic copies of the blockbuster drug Xeljanz (tofacitinib citrate), used to treat patients with arthritis.
The pharma company filed the complaint at the US District Court for the District of Delaware on June 7.
According the complaint, the action arises out of MSN’s filing of Abbreviated New Drug Applications (ANDAs) numbers 217299 and 217298, seeking approval by the US Food and Drug Administration (FDA) to sell generic copies of the drug before the expiration of the US number RE41,783 in 2025.
The active ingredient in Pfizer’s Xeljanz products is tofacitinib citrate, an inhibitor of Janus kinases, which treats adult patients with moderately to severely active rheumatoid arthritis.
Xeljanz tablets contain tofacitinib citrate in an amount equivalent to 5 mg and 10 mg of tofacitinib base in tablets formulated for twice-daily administration.
In September, 2010, the United States Patent and Trademark Office (USPTO) issued the RE’783 patent, titled “Pyrrolo[2,3-d]pyrimidine Compounds”.
The RE ’783 patent is a reissue of US Patent number 6,627,754, which was issued in September 2003.
In December 2016, the USPTO issued a Notice of Final Determination extending the expiration date of the RE’783 patent to December 8, 2025.
According to the complaint, MSN Labs wants to sell copies of Xeljanz’s twice-daily 5- and 10-milligram tablets and of its twice-daily oral solution.
Pfizer is demanding a permanent injunction preventing MSN from making, using, selling, offering for sale, marketing, distributing, or importing its generic before the expiration of the RE ’783 patent.
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