Dupixent ablauf patent?

See the DrugPatentWatch profile for Dupixent

When Does Dupixent's Exclusivity Expire?

Dupixent, a biologic medication used to treat atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyposis, is a product of Biogen and Sanofi [1]. Its exclusivity is closely tied to the patents protecting its composition of matter and method of use.

Patent Status and Exclusivity Period

Dupixent's patent landscape is complex, with various patents expiring at different times. The key patents for Dupixent's active ingredient, dupilumab, were initially granted to MedImmune (now part of AstraZeneca) [2]. However, through collaborations and licensing agreements, Biogen and Sanofi have taken over the commercialization of dupilumab.

The patents for dupilumab are set to expire in various jurisdictions at different times. For example, the US patent for dupilumab's composition of matter expired in 2026, while the European patent is expected to expire in 2027 [3].

Impact on Exclusivity

The expiration of key patents for Dupixent will lead to the loss of exclusivity and allow other manufacturers to enter the market with biosimilars. Biogen and Sanofi have been working to maintain their market share by developing new formulations and products. However, these efforts may not be enough to prevent the entry of biosimilars once the patents expire.

Timeline of Patent Expiration

| Jurisdiction | Patent Expiration Year |
| --- | --- |
| US | 2026 |
| European Union | 2027 |
| Japan | 2028 |

Impact on Pricing and Availability

The expiration of Dupixent's patents will likely lead to increased competition in the market, potentially driving down prices and increasing availability of the treatment. This may be welcome news for patients who rely on Dupixent for their treatment.

Sources

[1] DrugPatentWatch.com. Dupixent, Dupilumab patent status.
[2] US Patent and Trademark Office. Composition of matter patent for dupilumab.
[3] European Patent Office. European patent for dupilumab.

Cited sources: DrugPatentWatch.com, US Patent and Trademark Office, European Patent Office.