AQVESME

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Dec 23, 2025

   6 mo ago

2. Today

3. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Feb 17, 2027

   in 8 mo

4. Exclusivity ends · NP

   New product exclusivity (3 years)

   Dec 23, 2028

   in 2 yr 7 mo

5. Patent 10632114 expires

   Listed method-of-use patent (U-4391) expiration.

   May 03, 2032

   in 6 yr

6. Patent 9682080 expires

   Listed method-of-use patent (U-4392) expiration.

   May 03, 2032

   in 6 yr

7. Patent 9193701 expires

   Listed method-of-use patent (U-4393) expiration.

   Oct 26, 2032

   in 6 yr 5 mo

8. Exclusivity ends · ODE-522

   Orphan-drug exclusivity (7 years)

   Dec 23, 2032

   in 6 yr 7 mo

9. Patent RE49582 expires

   Listed drug substance patent expiration.

   Apr 11, 2035

   in 8 yr 11 mo

10. Patent 11254652 expires

    Listed drug substance patent expiration.

    Nov 21, 2038

    in 12 yr 7 mo

11. Patent 11878049 expires

    Listed method-of-use patent (U-4390) expiration.

    Jul 31, 2041

    in 15 yr 4 mo

Pharmaceutical detail

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (3)

• NCENew chemical entity exclusivity (5 years)

  Feb 17, 2027

  in 8 mo

• NPNew product exclusivity (3 years)

  Dec 23, 2028

  in 2 yr 7 mo

• ODE-522Orphan-drug exclusivity (7 years)

  Dec 23, 2032

  in 6 yr 7 mo

Listed patents (6)