oseltamivir phosphate · Roche · NDA 021087, 021246
Tamiflu
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 213437, Upsher Smith Labs · 021087-001Approved 22 Jan 2026Detected 25 Oct 2026Historical import
- Generic approved · ANDA 218307, Alembic · 021246-002Approved 25 Jun 2026Detected 25 Oct 2026Historical import
Products covered · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021087 · 001 · RLD | capsule, oral | EQ 75MG BASE | open |
| 021087 · 002 · RLD · discontinued | capsule, oral | EQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021087 · 003 · RLD · discontinued | capsule, oral | EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | open |
| 021246 · 001 · discontinued | for suspension, oral | EQ 12MG BASE/ML | open |
| 021246 · 002 · RLD | for suspension, oral | EQ 6MG BASE/ML | open |