grepcent public filings, reorganized for comparison

UBRELVY — FDA application NDA211765

Application NDA211765 · type NDA · FDA status: approved · original approval 2019-12-23

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
001UBRELVYUBROGEPANTTABLETORAL50MGPrescriptionnot listedYes
002UBRELVYUBROGEPANTTABLETORAL100MGPrescriptionnot 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 9499545001listed patent expiry date: 2031-11-10drug substance, drug product, U-2718
Patent 9499545002listed patent expiry date: 2031-11-10drug substance, drug product, U-2718
Patent 9833448001listed patent expiry date: 2031-11-10U-2718
Patent 9833448002listed patent expiry date: 2031-11-10U-2718
Patent 8754096001listed patent expiry date: 2032-07-19drug substance, drug product, U-2717
Patent 8754096002listed patent expiry date: 2032-07-19drug substance, drug product, U-2717
Patent 8912210001listed patent expiry date: 2033-12-23drug substance, drug product
Patent 8912210002listed patent expiry date: 2033-12-23drug substance, drug product
Patent 10117836001listed patent expiry date: 2035-01-30drug product
Patent 10117836002listed patent expiry date: 2035-01-30drug product
Patent 11925709001listed patent expiry date: 2035-01-30drug product
Patent 11925709002listed patent expiry date: 2035-01-30drug product
Patent 12168004001listed patent expiry date: 2035-01-30drug product
Patent 12168004002listed patent expiry date: 2035-01-30drug product
Patent 12220408001listed patent expiry date: 2035-01-30drug product
Patent 12220408002listed patent expiry date: 2035-01-30drug product
Patent 12310953001listed patent expiry date: 2035-01-30drug product
Patent 12310953002listed patent expiry date: 2035-01-30drug product
Patent 12458632001listed patent expiry date: 2035-01-30drug product
Patent 12458632002listed patent expiry date: 2035-01-30drug product
Patent 12458633001listed patent expiry date: 2035-01-30drug product
Patent 12458633002listed patent expiry date: 2035-01-30drug product
Patent 11717515001listed patent expiry date: 2041-12-22U-3677
Patent 11857542001listed patent expiry date: 2041-12-22U-3786
Patent 12070450002listed patent expiry date: 2041-12-22U-3992
Patent 12194030001listed patent expiry date: 2041-12-22U-4121
Patent 12194030001listed patent expiry date: 2041-12-22U-4122
Patent 12329750001listed patent expiry date: 2041-12-22U-4213
NDA211765 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA211765 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA211765 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 marker0.001.002.002019-12-231.002031-11-101.002032-07-191.002033-12-231.002035-01-301.002041-12-221.00

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.