cliffwatch

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

  • 25 Oct 2026First generic approved · 004782-001
  • 25 Oct 2026Generic approved · 004782-001
  • 25 Oct 2026First generic approved · 004782-001
  • 25 Oct 2026Generic approved · 004782-001

Products covered · 8

NDA · productFormStrengthListed expiry
004782 · 001 · RLDtablet, oral1.25MGopen
004782 · 002 · discontinuedtablet, oral2.5MGopen
004782 · 003 · RLDtablet, oral0.3MGopen
004782 · 004 · RLDtablet, oral0.625MGopen
004782 · 005 · RLDtablet, oral0.9MGopen
004782 · 006 · RLDtablet, oral0.45MGopen
010402 · 001 · RLDinjectable, injection25MG/VIALopen
020216 · 001 · RLDcream, topical, vaginal0.625MG/GMopen