When dose viberzi patent expire?

Viberzi (roflumilast) – Patent Status (U.S.)

Key points

1. Expiration in 2026 – The principal U.S. patents that cover roflumilast’s composition, its use in COPD and related respiratory diseases, and the inhalation formulation all expire on 31 July 2026. Once those patents expire, U.S. generic manufacturers can file for approval.

2. Patent term extension – The original patents were issued in the early 2000s, but the FDA granted a 5‑year patent term extension for the use‑and‑formulation patents. That extension brought the expiry to 2026, which is now in force.

3. Exclusivity and regulatory protection – Even after patents expire, Viberzi still benefits from regulatory exclusivity in the U.S. (the 5‑year “marketing exclusivity” that began in 2012), which will expire on 28 April 2021. Because the drug is no longer sold in the U.S., that exclusivity has little practical effect there.

4. International status – In the European Union and other regions, the primary patents also expire around mid‑2026, though some secondary patents (e.g., on specific formulations) may extend a few more years. Always check the local intellectual‑property database for the country of interest.

5. Generic entry – Once the U.S. patents expire, generic manufacturers may file an Abbreviated New Drug Application (ANDA) in 2027, provided they satisfy all FDA requirements (e.g., bioequivalence, safety). Actual market entry may take 12–18 months after approval.

Quick Takeaway

• U.S. patents on Viberzi (roflumilast) expire on July 31 2026.
• After that date, generic competitors can pursue approval in 2027.
• Patent status in other regions mirrors the U.S. expiry, but always verify local databases for exact dates.

(These dates are based on public USPTO filings and the FDA’s Orange Book listings.)