estrogens, conjugated · Wyeth Pharms · NDA 004782, 010402, 020216
Premarin
Earliest generic entry, as listed · earliest of 7 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
- First generic approved · ANDA 214025, Novast Labs · 004782-001Approved 15 Oct 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214025, Novast Labs · 004782-001Approved 15 Oct 2025Detected 25 Oct 2026Historical import
- First generic approved · ANDA 214023, Novast Labs · 004782-001Approved 15 Oct 2025Detected 25 Oct 2026Historical import
- Generic approved · ANDA 214023, Novast Labs · 004782-001Approved 15 Oct 2025Detected 25 Oct 2026Historical import
Products covered · 8
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 004782 · 001 · RLD | tablet, oral | 1.25MG | open |
| 004782 · 002 · discontinued | tablet, oral | 2.5MG | open |
| 004782 · 003 · RLD | tablet, oral | 0.3MG | open |
| 004782 · 004 · RLD | tablet, oral | 0.625MG | open |
| 004782 · 005 · RLD | tablet, oral | 0.9MG | open |
| 004782 · 006 · RLD | tablet, oral | 0.45MG | open |
| 010402 · 001 · RLD | injectable, injection | 25MG/VIAL | open |
| 020216 · 001 · RLD | cream, topical, vaginal | 0.625MG/GM | open |