ORLYNVAH

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Oct 25, 2024

   1 yr 8 mo ago

2. Today

3. Patent 7795243 expires

   Listed drug substance patent expiration.

   Jun 03, 2029

   in 3 yr

4. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Oct 25, 2029

   in 3 yr 5 mo

5. Exclusivity ends · GAIN

   Qualified infectious disease product exclusivity (adds 5 years)

   Oct 25, 2034

   in 8 yr 6 mo

6. Patent 11554112 expires

   Listed method-of-use patent (U-4026) expiration.

   Apr 01, 2039

   in 13 yr

7. Patent 12109197 expires

   Listed method-of-use patent (U-4026) expiration.

   Apr 01, 2039

   in 13 yr

8. Patent 11478428 expires

   Listed drug product patent expiration.

   Dec 23, 2039

   in 13 yr 9 mo

9. Patent 12544337 expires

   Listed drug product patent expiration.

   Dec 23, 2039

   in 13 yr 9 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 (2)

• NCENew chemical entity exclusivity (5 years)

  Oct 25, 2029

  in 3 yr 5 mo

• GAINQualified infectious disease product exclusivity (adds 5 years)

  Oct 25, 2034

  in 8 yr 6 mo

Listed patents (5)