SKYCLARYS

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Feb 28, 2023

   3 yr 4 mo ago

2. Today

3. Exclusivity ends · M-270

   New use / labeling-change exclusivity (3 years)

   Dec 20, 2027

   in 1 yr 6 mo

4. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Feb 28, 2028

   in 1 yr 9 mo

5. Patent 11091430 expires

   Listed method-of-use patent (U-3552) expiration.

   Apr 20, 2029

   in 2 yr 11 mo

6. Patent 11919838 expires

   Listed method-of-use patent (U-3862) expiration.

   Apr 20, 2029

   in 2 yr 11 mo

7. Patent 11919838 expires

   Listed method-of-use patent (U-3863) expiration.

   Apr 20, 2029

   in 2 yr 11 mo

8. Patent 8440854 expires

   Listed drug product patent expiration.

   Apr 20, 2029

   in 2 yr 11 mo

9. Patent 9670147 expires

   Listed drug substance patent expiration.

   Apr 20, 2029

   in 2 yr 11 mo

10. Patent 8124799 expires

    Listed drug substance patent expiration.

    Dec 03, 2029

    in 3 yr 6 mo

11. Exclusivity ends · ODE-427

    Orphan-drug exclusivity (7 years)

    Feb 28, 2030

    in 3 yr 9 mo

12. Patent 8993640 expires

    Listed drug substance patent expiration.

    Apr 24, 2033

    in 6 yr 11 mo

13. Patent 9701709 expires

    Listed drug substance patent expiration.

    Apr 24, 2033

    in 6 yr 11 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)

• M-270New use / labeling-change exclusivity (3 years)

  Dec 20, 2027

  in 1 yr 6 mo

• NCENew chemical entity exclusivity (5 years)

  Feb 28, 2028

  in 1 yr 9 mo

• ODE-427Orphan-drug exclusivity (7 years)

  Feb 28, 2030

  in 3 yr 9 mo

Listed patents (8)