CRESEMBA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Mar 06, 2015

   11 yr 5 mo ago

2. Exclusivity ends · ODE-305

   Orphan-drug exclusivity (7 years)

   Mar 06, 2022

   4 yr 4 mo ago

3. Exclusivity ends · ODE-90

   Orphan-drug exclusivity (7 years)

   Mar 06, 2022

   4 yr 4 mo ago

4. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Sep 06, 2022

   3 yr 10 mo ago

5. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Sep 06, 2022

   3 yr 10 mo ago

6. Patent 6812238 expires

   Listed drug substance patent expiration.

   Oct 31, 2025

   8 mo ago

7. Patent 6812238*PED expires

   Listed listed patent expiration.

   Apr 30, 2026

   2 mo ago

8. Today

9. Exclusivity ends · NPP

   New patient population exclusivity (3 years)

   Dec 08, 2026

   in 6 mo

10. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Jun 08, 2027

    in 1 yr

11. Exclusivity ends · GAIN

    Qualified infectious disease product exclusivity (adds 5 years)

    Sep 06, 2027

    in 1 yr 3 mo

12. Exclusivity ends · GAIN

    Qualified infectious disease product exclusivity (adds 5 years)

    Sep 06, 2027

    in 1 yr 3 mo

13. Exclusivity ends · ODE-453

    Orphan-drug exclusivity (7 years)

    Dec 08, 2030

    in 4 yr 6 mo

14. Exclusivity ends · ODE-459

    Orphan-drug exclusivity (7 years)

    Dec 08, 2030

    in 4 yr 6 mo

15. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Jun 08, 2031

    in 5 yr 1 mo

16. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Jun 08, 2031

    in 5 yr 1 mo

Pharmaceutical detail

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

• CRESEMBABrand (NDA)

  NDA 207500 · ASTELLAS

  2022

Marketing exclusivity (12)

• ODE-305Orphan-drug exclusivity (7 years)

  Mar 06, 2022

  4 yr 4 mo ago

• ODE-90Orphan-drug exclusivity (7 years)

  Mar 06, 2022

  4 yr 4 mo ago

• PEDPediatric exclusivity (adds 6 months)

  Sep 06, 2022

  3 yr 10 mo ago

• PEDPediatric exclusivity (adds 6 months)

  Sep 06, 2022

  3 yr 10 mo ago

• NPPNew patient population exclusivity (3 years)

  Dec 08, 2026

  in 6 mo

• PEDPediatric exclusivity (adds 6 months)

  Jun 08, 2027

  in 1 yr

• GAINQualified infectious disease product exclusivity (adds 5 years)

  Sep 06, 2027

  in 1 yr 3 mo

• GAINQualified infectious disease product exclusivity (adds 5 years)

  Sep 06, 2027

  in 1 yr 3 mo

• ODE-453Orphan-drug exclusivity (7 years)

  Dec 08, 2030

  in 4 yr 6 mo

• ODE-459Orphan-drug exclusivity (7 years)

  Dec 08, 2030

  in 4 yr 6 mo

• PEDPediatric exclusivity (adds 6 months)

  Jun 08, 2031

  in 5 yr 1 mo

• PEDPediatric exclusivity (adds 6 months)

  Jun 08, 2031

  in 5 yr 1 mo

Listed patents (2)