elagolix sodium,estradiol,norethindrone acetate; elagolix sodium · Abbvie · NDA 213388

Oriahnn (Copackaged)

Earliest generic entry, as listed
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 · 7 unexpired

PatentClaimsExpires
US 11690845use U-365527 Aug 2040
US 11542239substance, product23 Jul 2039
US 12083227product, use U-284220 Aug 2038
US 10881659use U-284214 Mar 2034
US 11045470use U-284214 Mar 2034
US 7419983substance, product6 Jul 2029
US 11459305product, use U-28427 Nov 2028

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 · 1

NDA · productFormStrengthListed expiry
213388 · 001 · RLDcapsule, oralEQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE27 Aug 2040