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. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

FDA has approved 1 generic application (ANDA) for Imvexxy, though its earliest generic-entry date is 2 Feb 2034 as listed. A generic can be approved before that date when it leaves out a patented use (a section viii carve-out), challenges a patent, or settles with the brand company. An approval is not a launch: cliffwatch does not track launches. Approval is not launch

Listed patents · 20 unexpired

34 Orange Book listing rows for 20 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 11266661use U-2316, U-23172 Feb 2034
US 11266661 listing rowuse U-2316 · sets the listed date2 Feb 2034
US 11266661 listing rowuse U-2317 · sets the listed date2 Feb 2034
US 10258630use U-2316, U-231721 Nov 2032
US 10258630 listing rowuse U-231621 Nov 2032
US 10258630 listing rowuse U-231721 Nov 2032
US 10398708use U-2317, U-261421 Nov 2032
US 10398708 listing rowuse U-231721 Nov 2032
US 10398708 listing rowuse U-261421 Nov 2032
US 10471072use U-2316, U-231721 Nov 2032
US 10471072 listing rowuse U-231621 Nov 2032
US 10471072 listing rowuse U-231721 Nov 2032
US 10537581drug product, use U-2316, U-231721 Nov 2032
US 10537581 listing rowdrug product, use U-231621 Nov 2032
US 10537581 listing rowdrug product, use U-231721 Nov 2032
US 10568891use U-2316, U-231721 Nov 2032
US 10568891 listing rowuse U-231621 Nov 2032
US 10568891 listing rowuse U-231721 Nov 2032
US 10668082use U-2316, U-231721 Nov 2032
US 10668082 listing rowuse U-231621 Nov 2032
US 10668082 listing rowuse U-231721 Nov 2032
US 10806697drug product21 Nov 2032
US 10835487use U-2316, U-231721 Nov 2032
US 10835487 listing rowuse U-231621 Nov 2032
US 10835487 listing rowuse U-231721 Nov 2032
US 10888516use U-2316, U-231721 Nov 2032
US 10888516 listing rowuse U-231621 Nov 2032
US 10888516 listing rowuse U-231721 Nov 2032
US 11065197drug product21 Nov 2032
US 11116717drug product21 Nov 2032
US 11123283drug product21 Nov 2032
US 11241445use U-2316, U-231721 Nov 2032
US 11241445 listing rowuse U-231621 Nov 2032
US 11241445 listing rowuse U-231721 Nov 2032
US 11246875use U-2316, U-231721 Nov 2032
US 11246875 listing rowuse U-231621 Nov 2032
US 11246875 listing rowuse U-231721 Nov 2032
US 11304959drug product21 Nov 2032
US 11351182use U-2316, U-231721 Nov 2032
US 11351182 listing rowuse U-231621 Nov 2032
US 11351182 listing rowuse U-231721 Nov 2032
US 11497709use U-2316, U-231721 Nov 2032
US 11497709 listing rowuse U-231621 Nov 2032
US 11497709 listing rowuse U-231721 Nov 2032
US 9180091drug product, use U-2316, U-231721 Nov 2032
US 9180091 listing rowdrug product, use U-231621 Nov 2032
US 9180091 listing rowdrug product, use U-231721 Nov 2032
US 9289382drug product21 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

  • First generic approved · ANDA 214137, Teva Pharms Usa Inc · 208564-001Approved 8 Dec 2025Detected 25 Oct 2026Historical import
  • Generic approved · ANDA 214137, Teva Pharms Usa Inc · 208564-001Approved 8 Dec 2025Detected 25 Oct 2026Historical import

Products covered · 2

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