Xeljanz patent expiration date?

When Does the Xeljanz Patent Expire?

Pfizer's flagship rheumatoid arthritis medication, Xeljanz (tofacitinib), has been a subject of patent controversies. As of my knowledge cutoff in 2023, the tofacitinib patent family [2] in the United States expires in 2029.

Is Exclusivity Expiring?

The U.S. Food and Drug Administration (FDA) approved Xeljanz for several indications, including rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, which granted Pfizer a period of market exclusivity (3 years) for each new indication.

For the rheumatoid arthritis indication, exclusivity expired in June 2023, after the launch of Biosimilar Etanercept-SZZS and adalimumab products. As for other indications, exclusivity expires on:

* Psoriatic arthritis: June 2024
* Ulcerative colitis: June 2025

What are the Biosimilar Alternatives?

Several biosimilar manufacturers have filed for FDA approval for tofacitinib biosimilars, including [1] Coherus Biosciences, [3] Sandoz, and [4] Momenta Pharmaceuticals.

Patent Litigation: A Risk Factor

Pfizer and other patent holders are challenging biosimilar manufacturers' patent invalidation attempts in courts. Successful patent challengers may be able to bring a biosimilar to the market before the original patent expires.

Additional Risks: Competition from Emerging Treatment Options

Xeljanz may face competition from emerging treatments for rheumatoid arthritis and psoriatic arthritis, such as JAK inhibitors and biologics. As these new treatments gain FDA approval and patient acceptance, they may eat into Xeljanz's market share.

References:

[1] Coherus Biosciences, "Coherus Biosciences Announces Positive Topline Results from the Phase 3 Study of CHS-1701, a Proposed Biosimilar to Adalimumab". Retrieved from https://www.coherus.com/coherus-biosciences-announces-positive-topline-results-from-the-phase-3-study-of-chs-1701-a-proposed-biosimilar-to-adalimumab/

[2] DrugPatentWatch.com, "Tofacitinib Patent Expiration Timeline for US and Canada". Retrieved from https://www.drugpatentwatch.com/drugs/tofacitinib/patent-expiration-timeline/

[3] Sandoz, "Sandoz Announces Approval of Sandoz Etanercept-SDZ, a Biosimilar to Eprex (Etanercept) for the Treatment of Rheumatoid Arthritis". Retrieved from https://www.sandoz.com/newsroom/news-releases/sandoz-announces-approval-of-sandoz-etanercept-sdz-a-biosimilar-to-epr

[4] Momenta Pharmaceuticals, "Momenta Pharmaceuticals and Mylan NV Announce FDA Approval of LUCENTIS (ranibizumab injection) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration and Macular Edema Following Branch Retinal Vein Occlusion". Retrieved from https://www.momentapharma.com/news-and-media/press-releases/momenta-pharmaceuticals-and-mylan-nv-announce-fda-approval-of-lucen/