NEXLETOL

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Feb 21, 2020

   6 yr 5 mo ago

2. Today

3. Exclusivity ends · I-943

   New indication exclusivity (3 years)

   Mar 22, 2027

   in 9 mo

4. Exclusivity ends · I-944

   New indication exclusivity (3 years)

   Mar 22, 2027

   in 9 mo

5. Patent 7335799 expires

   Listed drug substance patent expiration.

   Dec 03, 2030

   in 4 yr 6 mo

6. Patent 11744816 expires

   Listed method-of-use patent (U-3883) expiration.

   Mar 14, 2036

   in 9 yr 11 mo

7. Patent 11613511 expires

   Listed drug substance patent expiration.

   Jun 19, 2040

   in 14 yr 2 mo

8. Patent 11760714 expires

   Listed drug product patent expiration.

   Jun 19, 2040

   in 14 yr 2 mo

9. Patent 11926584 expires

   Listed method-of-use patent (U-3873) expiration.

   Jun 19, 2040

   in 14 yr 2 mo

10. Patent 12398087 expires

    Listed drug substance patent expiration.

    Jun 19, 2040

    in 14 yr 2 mo

11. Patent 12404227 expires

    Listed drug substance patent expiration.

    Jun 19, 2040

    in 14 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)

• I-943New indication exclusivity (3 years)

  Mar 22, 2027

  in 9 mo

• I-944New indication exclusivity (3 years)

  Mar 22, 2027

  in 9 mo

Listed patents (7)