BAXDELA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Jun 19, 2017

   9 yr 2 mo ago

2. Exclusivity ends · NCE

   New chemical entity exclusivity (5 years)

   Jun 19, 2022

   4 yr 1 mo ago

3. Today

4. Patent 8273892 expires

   Listed drug substance patent expiration.

   Aug 06, 2026

   in 2 mo

5. Patent 8252813 expires

   Listed drug product patent expiration.

   Oct 02, 2026

   in 4 mo

6. Exclusivity ends · GAIN

   Qualified infectious disease product exclusivity (adds 5 years)

   Jun 19, 2027

   in 1 yr

7. Patent 8871938 expires

   Listed drug substance patent expiration.

   Sep 23, 2029

   in 3 yr 4 mo

8. Patent RE46617 expires

   Listed drug substance patent expiration.

   Dec 28, 2029

   in 3 yr 7 mo

9. Patent 7728143 expires

   Listed drug substance patent expiration.

   Jun 19, 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.

• BAXDELABrand (NDA)

  NDA 208611 · MELINTA

  2017

Marketing exclusivity (2)

• NCENew chemical entity exclusivity (5 years)

  Jun 19, 2022

  4 yr 1 mo ago

• GAINQualified infectious disease product exclusivity (adds 5 years)

  Jun 19, 2027

  in 1 yr

Listed patents (5)