cliffwatch

estradiol · Mayne Pharma · NDA 208564

Imvexxy

Earliest generic entry, as listed · earliest of 2 marketed strengths
2 Feb 2034

Blocked by patent: US 11266661, US 11266661. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 34 unexpired

PatentClaimsExpires
US 11266661use U-23162 Feb 2034
US 11266661use U-23172 Feb 2034
US 10258630use U-231721 Nov 2032
US 10258630use U-231621 Nov 2032
US 10398708use U-231721 Nov 2032
US 10398708use U-261421 Nov 2032
US 10471072use U-231721 Nov 2032
US 10471072use U-231621 Nov 2032
US 10537581product, use U-231621 Nov 2032
US 10537581product, use U-231721 Nov 2032
US 10568891use U-231721 Nov 2032
US 10568891use U-231621 Nov 2032
US 10668082use U-231721 Nov 2032
US 10668082use U-231621 Nov 2032
US 10806697product21 Nov 2032
US 10835487use U-231721 Nov 2032
US 10835487use U-231621 Nov 2032
US 10888516use U-231621 Nov 2032
US 10888516use U-231721 Nov 2032
US 11065197product21 Nov 2032
US 11116717product21 Nov 2032
US 11123283product21 Nov 2032
US 11241445use U-231621 Nov 2032
US 11241445use U-231721 Nov 2032
US 11246875use U-231621 Nov 2032
US 11246875use U-231721 Nov 2032
US 11304959product21 Nov 2032
US 11351182use U-231721 Nov 2032
US 11351182use U-231621 Nov 2032
US 11497709use U-231721 Nov 2032
US 11497709use U-231621 Nov 2032
US 9180091product, use U-231721 Nov 2032
US 9180091product, use U-231621 Nov 2032
US 9289382product21 Nov 2032

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 · 208564-001
  • 25 Oct 2026Generic approved · 208564-001

Products covered · 2

NDA · productFormStrengthListed expiry
208564 · 001 · RLDinsert, vaginal0.004MG2 Feb 2034
208564 · 002 · RLDinsert, vaginal0.01MG2 Feb 2034