BLUJEPA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Mar 25, 2025

   1 yr 3 mo ago

2. Today

3. Exclusivity ends · I-978

   New indication exclusivity (3 years)

   Dec 11, 2028

   in 2 yr 6 mo

4. Patent 8389524 expires

   Listed drug substance patent expiration.

   Feb 12, 2029

   in 2 yr 8 mo

5. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Mar 25, 2030

   in 3 yr 10 mo

6. Exclusivity ends · GAIN

   Qualified infectious disease product exclusivity (adds 5 years)

   Mar 25, 2035

   in 8 yr 11 mo

7. Patent 10702521 expires

   Listed method-of-use patent (U-4361) expiration.

   Aug 20, 2035

   in 9 yr 4 mo

8. Patent 11229646 expires

   Listed method-of-use patent (U-4361) expiration.

   Aug 20, 2035

   in 9 yr 4 mo

9. Patent 12528809 expires

   Listed drug substance patent expiration.

   Dec 13, 2042

   in 16 yr 9 mo

10. Patent 12528809 expires

    Listed drug substance patent expiration.

    Dec 13, 2042

    in 16 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 (3)

• I-978New indication exclusivity (3 years)

  Dec 11, 2028

  in 2 yr 6 mo

• NCENew chemical entity exclusivity (5 years)

  Mar 25, 2030

  in 3 yr 10 mo

• GAINQualified infectious disease product exclusivity (adds 5 years)

  Mar 25, 2035

  in 8 yr 11 mo

Listed patents (5)