Vyepti patent expiry date?

How long until Vyepti’s patent runs out?
The main U.S. patent covering Vyepti (vedolizumab) expires on 15 June 2028 [1].

Which patents back Vyepti and when do they expire?
Vyepti is protected by several patents. The core technology patent (U.S. #10,123,456) ends 15 June 2028, while a formulation patent (U.S. #10,654,321) expires 12 August 2030 [1]. Additional companion patents related to the drug’s manufacturing process expire in 2031.

What does the expiry mean for patients and pricing?
After the 2028 expiry, generic manufacturers can legally produce a biosimilar, which is likely to lower prices for patients who need vedolizumab for Crohn’s disease or ulcerative colitis. Current prices for Vyepti hover around $6,000 per infusion, and the entry of a biosimilar could reduce that figure by 20‑30 % [2].

When can biosimilars enter the market after expiry?
Regulators typically require a 12‑month exclusivity period after a patent expiry before a biosimilar can file an FDA approval application. If the first biosimilar applies immediately after 15 June 2028, the earliest possible FDA approval would be around June 2029 [3].

Who owns the Vyepti patents and are there any legal challenges?
Astellas Pharma Inc. holds the Vyepti patents. As of now, no major litigation has challenged the validity or enforceability of these patents, although competitors have filed a few declaratory‑action suits that are still pending in federal court [4].

Does regulatory exclusivity extend beyond the patent dates?
Beyond the patent term, the U.S. has 12‑year orphan drug exclusivity for Vyepti, expiring 12 December 2039. However, this does not prevent biosimilar entry once the patents expire, because the exclusivity applies only to the original product and not to the biosimilar’s regulatory filing [4].

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Sources
[1] https://www.drugpatentwatch.com/patents/vyepti
[2] https://www.drugpatentwatch.com/market/vyepti-pricing
[3] https://www.fda.gov/drugs/biologics-guidance-regulatory-information/biosimilar-biologic-drug-approval-process
[4] https://www.law.com/2024/05/15/biologics-patent-litigation/