grepcent public filings, reorganized for comparison

ORIAHNN (COPACKAGED) — FDA application NDA213388

Application NDA213388 · type NDA · FDA status: approved · original approval 2020-05-29

Listed sponsor: ABBVIE · ABBV company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001ORIAHNN (COPACKAGED)ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUMCAPSULEORALEQ 300MG BASE,1MG,0.5MG; EQ 300MG BASEPrescriptionnot listedYes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Orange Book patent and exclusivity listings

ListingProductDescriptive dateFlags/code
Patent 11459305001listed patent expiry date: 2028-11-07drug product, U-2842
Patent 7419983001listed patent expiry date: 2029-07-06drug substance, drug product
Patent 10881659001listed patent expiry date: 2034-03-14U-2842
Patent 11045470001listed patent expiry date: 2034-03-14U-2842
Patent 12083227001listed patent expiry date: 2038-08-20drug product, U-2842
Patent 11542239001listed patent expiry date: 2039-07-23drug substance, drug product
Patent 11690845001listed patent expiry date: 2040-08-27U-3655
NDA213388 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA213388 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA213388 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002020-05-291.002028-11-071.002029-07-061.002034-03-141.002038-08-201.002039-07-231.002040-08-271.00

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

Compound cross-links

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Related pages

Sponsor company · FDA-approved application index

Peer clusters: Large-cap biopharma

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.