isotretinoin · Sun Pharm · NDA 211913
Absorica Ld
Earliest generic entry, as listed · earliest of 4 marketed strengths
4 Aug 2035
Blocked by patent: US 9700535.
FDA has approved 1 generic application (ANDA) for Absorica Ld, though its earliest generic-entry date is 4 Aug 2035 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9700535 | drug product · sets the listed date | 4 Aug 2035 |
| US 9750711 | drug product | 29 May 2035 |
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 220336, Aurobindo Pharma Ltd · 211913-001Approved 10 Sep 2026Detected 25 Oct 2026
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211913 · 001 · RLD | capsule, oral | 8MG | 4 Aug 2035 |
| 211913 · 002 · RLD | capsule, oral | 16MG | 4 Aug 2035 |
| 211913 · 003 · RLD · discontinued | capsule, oral | 20MG | 4 Aug 2035 |
| 211913 · 004 · RLD | capsule, oral | 24MG | 4 Aug 2035 |
| 211913 · 005 · RLD · discontinued | capsule, oral | 28MG | 4 Aug 2035 |
| 211913 · 006 · RLD | capsule, oral | 32MG | 4 Aug 2035 |