isotretinoin · Sun Pharm Inds Inc · NDA 021951
Absorica
Earliest generic entry, as listed · earliest of 6 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 216097, Amneal Pharms Ny · 021951-001Approved 7 Oct 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 220336, Aurobindo Pharma Ltd · 021951-001Approved 10 Sep 2026Detected 25 Oct 2026Historical import
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021951 · 001 · RLD | capsule, oral | 10MG | open |
| 021951 · 002 · RLD | capsule, oral | 20MG | open |
| 021951 · 003 · RLD | capsule, oral | 30MG | open |
| 021951 · 004 · RLD | capsule, oral | 40MG | open |
| 021951 · 005 · RLD | capsule, oral | 25MG | open |
| 021951 · 006 · RLD | capsule, oral | 35MG | open |