elagolix sodium · Abbvie · NDA 210450

Orilissa

Earliest generic entry, as listed · earliest of 2 marketed strengths
27 Aug 2040

Blocked by patent: US 11690845. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.

Listed patents · 10 unexpired

PatentClaimsExpires
US 11690845use U-365427 Aug 2040
US 11542239substance, product23 Jul 2039
US 12102637product20 Aug 2038
US 11690854use U-365319 Apr 2038
US 10537572use U-27351 Sep 2036
US 10682351use U-28501 Sep 2036
US 11344551use U-338914 Mar 2034
US 11344551use U-338814 Mar 2034
US 11707464use U-367214 Mar 2034
US 7419983substance, product, use U-23606 Jul 2029

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

No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.

Products covered · 2

NDA · productFormStrengthListed expiry
210450 · 001 · RLDtablet, oralEQ 150MG BASE27 Aug 2040
210450 · 002 · RLDtablet, oralEQ 200MG BASE27 Aug 2040