BREXAFEMME

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Jun 01, 2021

   5 yr 1 mo ago

2. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Jun 01, 2026

   18 d ago

3. Today

4. Patent 8188085 expires

   Listed drug substance patent expiration.

   Aug 28, 2030

   in 4 yr 3 mo

5. Exclusivity ends · GAIN

   Qualified infectious disease product exclusivity (adds 5 years)

   Jun 01, 2031

   in 5 yr

6. Patent 10174074 expires

   Listed drug substance patent expiration.

   Jan 19, 2035

   in 8 yr 9 mo

7. Patent 10370406 expires

   Listed method-of-use patent (U-3159) expiration.

   Jan 19, 2035

   in 8 yr 9 mo

8. Patent 10927142 expires

   Listed drug substance patent expiration.

   Jan 19, 2035

   in 8 yr 9 mo

9. Patent 11534433 expires

   Listed method-of-use patent (U-3159) expiration.

   Jun 10, 2039

   in 13 yr 2 mo

10. Patent 11534433 expires

    Listed method-of-use patent (U-3508) expiration.

    Jun 10, 2039

    in 13 yr 2 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)

  Jun 01, 2026

  18 d ago

• GAINQualified infectious disease product exclusivity (adds 5 years)

  Jun 01, 2031

  in 5 yr

Listed patents (6)