irbesartan · Sanofi Aventis Us · NDA 020757
Avapro
Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
- 25 Oct 2026Generic approved · 020757-0014 Nov 2025
Products covered · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 020757 · 001 · RLD · discontinued | tablet, oral | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020757 · 002 · RLD | tablet, oral | 150MG | open |
| 020757 · 003 · RLD | tablet, oral | 300MG | open |