OPSYNVI

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Mar 22, 2024

   2 yr 3 mo ago

2. Patent 7094781 expires

   Listed drug substance patent expiration.

   Dec 05, 2025

   7 mo ago

3. Patent 7094781*PED expires

   Listed listed patent expiration.

   Jun 05, 2026

   14 d ago

4. Today

5. Patent 10946015 expires

   Listed drug product patent expiration.

   Sep 11, 2026

   in 3 mo

6. Patent 10946015*PED expires

   Listed listed patent expiration.

   Mar 11, 2027

   in 9 mo

7. Exclusivity ends · NP

   New product exclusivity (3 years)

   Mar 22, 2027

   in 9 mo

8. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Sep 22, 2027

   in 1 yr 3 mo

9. Patent 8268847 expires

   Listed drug product patent expiration.

   Apr 18, 2029

   in 2 yr 10 mo

10. Patent 8268847*PED expires

    Listed listed patent expiration.

    Oct 18, 2029

    in 3 yr 5 mo

11. Exclusivity ends · ODE-475

    Orphan-drug exclusivity (7 years)

    Mar 22, 2031

    in 4 yr 10 mo

12. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Sep 22, 2031

    in 5 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 (4)

• NPNew product exclusivity (3 years)

  Mar 22, 2027

  in 9 mo

• PEDPediatric exclusivity (adds 6 months)

  Sep 22, 2027

  in 1 yr 3 mo

• ODE-475Orphan-drug exclusivity (7 years)

  Mar 22, 2031

  in 4 yr 10 mo

• PEDPediatric exclusivity (adds 6 months)

  Sep 22, 2031

  in 5 yr 4 mo

Listed patents (6)