ibuprofen · Mcneil Consumer · NDA 017463, 019842, 020135, 020418, 020476
Motrin
Earliest generic entry, as listed · earliest of 5 marketed strengths
Open now
No marketed reference-listed strength; date taken from all listed strengths.
No unexpired patents or exclusivities are listed for this product.
Listed patents · 0 unexpired
No unexpired patents listed.
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 220239, Rubicon Research · 019842-001Approved 5 Mar 2026Detected 25 Oct 2026Historical import
Products covered · 9
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 017463 · 002 · RLD · discontinued | tablet, oral | 400MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 017463 · 003 · RLD · discontinued | tablet, oral | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 017463 · 004 · RLD · discontinued | tablet, oral | 600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 017463 · 005 · RLD · discontinued | tablet, oral | 800MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 019842 · 001 · RLD · discontinued | suspension, oral | 100MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 020135 · 001 · discontinued | tablet, chewable, oral | 50MG | open |
| 020135 · 002 · discontinued | tablet, chewable, oral | 100MG | open |
| 020418 · 001 · discontinued | tablet, oral | 100MG | open |
| 020476 · 001 · discontinued | suspension/drops, oral | 40MG/ML | open |