ketorolac tromethamine · Abbvie · NDA 021528
Acular Ls
Earliest generic entry, as listed
24 Nov 2027
Blocked by patent: US 8008338 (pediatric extension).
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent, including 1 pediatric extension. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 8008338 | drug substance, drug product, use U-1181 | 24 Nov 2027 |
| US 8008338 listing row | drug substance, drug product, use U-1181 | 24 May 2027 |
| US 8008338 listing row | pediatric extension · sets the listed date | 24 Nov 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
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021528 · 001 · RLD | solution/drops, ophthalmic | 0.4% | 24 Nov 2027 |