AUGTYRO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Nov 15, 2023

   2 yr 8 mo ago

2. Today

3. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Nov 15, 2028

   in 2 yr 5 mo

4. Exclusivity ends · ODE-455

   Orphan-drug exclusivity (7 years)

   Nov 15, 2030

   in 4 yr 6 mo

5. Exclusivity ends · ODE-483

   Orphan-drug exclusivity (7 years)

   Jun 13, 2031

   in 5 yr 1 mo

6. Patent RE50634 expires

   Listed drug substance patent expiration.

   Jan 23, 2035

   in 8 yr 9 mo

7. Patent 10294242 expires

   Listed drug substance patent expiration.

   Jul 05, 2036

   in 10 yr 2 mo

8. Patent 12187739 expires

   Listed drug product patent expiration.

   Jul 05, 2036

   in 10 yr 2 mo

9. Patent 12310968 expires

   Listed method-of-use patent (U-3755) expiration.

   Jul 20, 2036

   in 10 yr 3 mo

10. Patent 11452725 expires

    Listed method-of-use patent (U-3961) expiration.

    Jul 24, 2036

    in 10 yr 3 mo

11. Patent 11452725 expires

    Listed method-of-use patent (U-3755) expiration.

    Jul 24, 2036

    in 10 yr 3 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)

  Nov 15, 2028

  in 2 yr 5 mo

• ODE-455Orphan-drug exclusivity (7 years)

  Nov 15, 2030

  in 4 yr 6 mo

• ODE-483Orphan-drug exclusivity (7 years)

  Jun 13, 2031

  in 5 yr 1 mo

Listed patents (6)