acetaminophen · Mallinckrodt Hosp · NDA 022450
Ofirmev
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 9399012.
FDA has approved 1 generic application (ANDA) for Ofirmev, though its earliest generic-entry date is 11 Mar 2032 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 · 10 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 9399012 | — | 11 Mar 2032 |
| US 9399012 | use U-2262 | 11 Sep 2031 |
| US 9399012 | use U-2261 | 11 Sep 2031 |
| US 10383834 | — | 13 May 2029 |
| US 9610265 | — | 13 May 2029 |
| US 9987238 | — | 13 May 2029 |
| US 10383834 | use U-2621 | 13 Nov 2028 |
| US 10383834 | use U-2262 | 13 Nov 2028 |
| US 9610265 | use U-2263 | 13 Nov 2028 |
| US 9987238 | use U-2261 | 13 Nov 2028 |
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
- 25 Oct 2026Generic approved · 022450-0015 Dec 2025
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022450 · 001 · RLD · discontinued | solution, intravenous | 1GM/100ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | 11 Mar 2032 |