acetaminophen; ibuprofen · Aft Pharms Us · NDA 209471
Combogesic
Earliest generic entry, as listed
27 Feb 2039
Blocked by patent: US 11197830, US 11534407.
FDA has approved 2 generic applications (ANDAs) for Combogesic, though its earliest generic-entry date is 27 Feb 2039 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 11197830 | drug product, use U-3553 · sets the listed date | 27 Feb 2039 |
| US 11534407 | drug product, use U-3553 · sets the listed date | 27 Feb 2039 |
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 220126, Lnk Intl Inc · 209471-001Approved 11 Dec 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 219053, Taro · 209471-001Approved 2 Jan 2026Detected 25 Oct 2026Historical import
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209471 · 001 · RLD | tablet, oral | 325MG;97.5MG | 27 Feb 2039 |
Expired or delisted (1)
- NP · 1 Mar 2026