NUZYRA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Oct 02, 2018

   7 yr 10 mo ago

2. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Oct 02, 2023

   2 yr 9 mo ago

3. Today

4. Exclusivity ends · GAIN

   Qualified infectious disease product exclusivity (adds 5 years)

   Oct 02, 2028

   in 2 yr 4 mo

5. Patent 10124014 expires

   Listed method-of-use patent (U-2449) expiration.

   Mar 05, 2029

   in 2 yr 9 mo

6. Patent 9724358 expires

   Listed method-of-use patent (U-1569) expiration.

   Mar 05, 2029

   in 2 yr 9 mo

7. Patent 8383610 expires

   Listed drug substance patent expiration.

   Sep 23, 2030

   in 4 yr 4 mo

8. Patent 9265740 expires

   Listed drug product patent expiration.

   Oct 24, 2030

   in 4 yr 5 mo

9. Patent 9314475 expires

   Listed drug product patent expiration.

   Mar 18, 2031

   in 4 yr 10 mo

10. Patent 10111890 expires

    Listed method-of-use patent (U-2444) expiration.

    Aug 03, 2037

    in 11 yr 3 mo

11. Patent 10383884 expires

    Listed method-of-use patent (U-2576) expiration.

    Oct 31, 2037

    in 11 yr 6 mo

12. Patent 10835542 expires

    Listed method-of-use patent (U-2576) expiration.

    Oct 31, 2037

    in 11 yr 6 mo

Pharmaceutical detail

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

• NUZYRABrand (NDA)

  NDA 209817 · PARATEK PHARMS

  2018

Marketing exclusivity (2)

• NCENew chemical entity exclusivity (5 years)

  Oct 02, 2023

  2 yr 9 mo ago

• GAINQualified infectious disease product exclusivity (adds 5 years)

  Oct 02, 2028

  in 2 yr 4 mo

Listed patents (8)