cliffwatch

ubrogepant · Abbvie · NDA 211765

Ubrelvy

Earliest generic entry, as listed · earliest of 2 marketed strengths
22 Dec 2041

Blocked by patent: US 11717515, US 11857542, US 12070450, US 12194030, US 12329750. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 16 unexpired

17 Orange Book listing rows for 16 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.

PatentClaimsExpires
US 11717515use U-3677 · sets the listed date22 Dec 2041
US 11857542use U-3786 · sets the listed date22 Dec 2041
US 12070450use U-3992 · sets the listed date22 Dec 2041
US 12194030use U-4121, U-412222 Dec 2041
US 12194030 listing rowuse U-4121 · sets the listed date22 Dec 2041
US 12194030 listing rowuse U-4122 · sets the listed date22 Dec 2041
US 12329750use U-4213 · sets the listed date22 Dec 2041
US 10117836drug product30 Jan 2035
US 11925709drug product30 Jan 2035
US 12168004drug product30 Jan 2035
US 12220408drug product30 Jan 2035
US 12310953drug product30 Jan 2035
US 12458632drug product30 Jan 2035
US 12458633drug product30 Jan 2035
US 8912210drug substance, drug product23 Dec 2033
US 8754096drug substance, drug product, use U-271719 Jul 2032
US 9499545drug substance, drug product, use U-271810 Nov 2031
US 9833448use U-271810 Nov 2031

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 2026Generic tentatively approved · 211765-001
  • 25 Oct 2026Generic tentatively approved · 211765-001

Products covered · 2

NDA · productFormStrengthListed expiry
211765 · 001 · RLDtablet, oral50MG22 Dec 2041
211765 · 002 · RLDtablet, oral100MG22 Dec 2041