bimatoprost · Abbvie · NDA 021275, 022184
Lumigan
Earliest generic entry, as listed
13 Jun 2027
Blocked by patent: US 7851504.
FDA has approved 1 generic application (ANDA) for Lumigan, though its earliest generic-entry date is 13 Jun 2027 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 · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 7851504 | drug substance, drug product · sets the listed date | 13 Jun 2027 |
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 217289, Amneal · 022184-001Approved 22 Sep 2025Detected 25 Oct 2026Historical import
- Enters 12-month window basis: patent · 022184-001Listed date 13 Jun 2027Detected 24 Oct 2026
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021275 · 001 · RLD · discontinued | solution/drops, ophthalmic | 0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 022184 · 001 · RLD | solution/drops, ophthalmic | 0.01% | 13 Jun 2027 |