naproxen · Atnahs Pharma Us · NDA 017581, 018965
Naprosyn
Earliest generic entry, as listed · earliest of 2 marketed strengths
Open now
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 216504, Aurobindo Pharma · 018965-001Approved 3 Oct 2025Detected 25 Oct 2026Historical import
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 017581 · 002 · RLD · discontinued | tablet, oral | 250MG | open |
| 017581 · 003 · RLD · discontinued | tablet, oral | 375MG | open |
| 017581 · 004 · RLD | tablet, oral | 500MG | open |
| 018965 · 001 · RLD | suspension, oral | 25MG/ML | open |