tretinoin · Bausch · NDA 016921, 017340, 017522, 017579, 017955, 019049
Retin-A
Earliest generic entry, as listed · earliest of 5 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
- Generic approved · ANDA 214590, Alembic · 017340-001Approved 11 Jun 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217497, Amneal · 017955-001Approved 14 May 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217832, Encube · 017340-001Approved 25 Mar 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 217833, Encube · 017340-001Approved 10 Feb 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218560, Zydus Lifesciences · 017340-001Approved 15 Sep 2026Detected 25 Oct 2026Historical import
Products covered · 7
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 016921 · 001 · RLD · discontinued | solution, topical | 0.05% | open |
| 016921 · 002 · discontinued | swab, topical | 0.05% | open |
| 017340 · 001 · RLD | cream, topical | 0.1% | open |
| 017522 · 001 · RLD | cream, topical | 0.05% | open |
| 017579 · 002 · RLD | gel, topical | 0.025% | open |
| 017955 · 001 · RLD | gel, topical | 0.01% | open |
| 019049 · 001 · RLD | cream, topical | 0.025% | open |