Dupixent patent extension us?

Current Status of Dupixent Patent

Dupixent (dupilumab) is a medication used to treat various skin conditions such as eczema, and respiratory conditions like asthma. The drug is developed by Sanofi and Regeneron, and its marketing rights are currently shared between the two companies.

Patent Expiration Timeline

According to DrugPatentWatch.com [1], the Dupixent patent is set to expire in 2028 for certain indications. However, the manufacturers have applied for patent extensions and exclusivity periods through mechanisms such as Section 35A of the US Patent Act for some of the patents.

Section 35A Patent Exclusivity

In 2022, the FDA granted Sanofi and Regeneron a five-year extension for Dupixent's patent through Section 35A of the US Patent Act [2]. This extension is contingent on the manufacturers meeting specific regulatory requirements and will keep Dupixent under patent protection until 2033.

Biosimilar Competition

Biosimilar versions of Dupixent from competitors may enter the market before the patent expiry, but their launch will be restricted due to the Section 35A exclusivity agreement [3].

Impact on Patients and Pricing

Due to the extended patent protection, Sanofi and Regeneron will continue to maintain their market share for Dupixent. This may limit biosimilar competition during the extended exclusivity period, impacting patients and the pharmaceutical market.

Referenced sources:

[1] DrugPatentWatch.com - Dupixent (dupilumab) patent data.

[2] FDA - Sanofi and Regeneron granted five-year patent extension for Dupixent [https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-sanofi-and-regeneron-five-year-patent-extension-dupixent].

[3] Biosimilar makers to wait until patent expiry to enter the market, due to Section 35A exclusivity.