grepcent public filings, reorganized for comparison

SAPHRIS — FDA application NDA022117

Application NDA022117 · type NDA · FDA status: approved · original approval 2009-08-13

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
001SAPHRISASENAPINE MALEATETABLETSUBLINGUALEQ 5MG BASEPrescriptionABYes
002SAPHRISASENAPINE MALEATETABLETSUBLINGUALEQ 10MG BASEPrescriptionABYes
003SAPHRISASENAPINE MALEATETABLETSUBLINGUALEQ 2.5MG BASEPrescriptionABYes

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 7741358001listed patent expiry date: 2026-04-06drug substance, drug product, U-1960
Patent 7741358001listed patent expiry date: 2026-04-06drug substance, drug product, U-1064
Patent 7741358001listed patent expiry date: 2026-04-06drug substance, drug product, U-1961
Patent 7741358001listed patent expiry date: 2026-04-06drug substance, drug product, U-1962
Patent 7741358001listed patent expiry date: 2026-04-06drug substance, drug product, U-1963
Patent 7741358002listed patent expiry date: 2026-04-06drug substance, drug product, U-1963
Patent 7741358002listed patent expiry date: 2026-04-06drug substance, drug product, U-1064
Patent 7741358002listed patent expiry date: 2026-04-06drug substance, drug product, U-1961
Patent 7741358002listed patent expiry date: 2026-04-06drug substance, drug product, U-1960
Patent 7741358002listed patent expiry date: 2026-04-06drug substance, drug product, U-1962
Patent 7741358003listed patent expiry date: 2026-04-06drug substance, drug product, U-1966
Patent 7741358003listed patent expiry date: 2026-04-06drug substance, drug product, U-1893
Patent 8022228001listed patent expiry date: 2026-04-06drug substance, drug product
Patent 8022228002listed patent expiry date: 2026-04-06drug substance, drug product
Patent 8022228003listed patent expiry date: 2026-04-06drug substance, drug product
Patent 7741358001listed patent expiry date: 2026-10-06pediatric extension
Patent 7741358002listed patent expiry date: 2026-10-06pediatric extension
Patent 7741358003listed patent expiry date: 2026-10-06pediatric extension
Patent 8022228001listed patent expiry date: 2026-10-06pediatric extension
Patent 8022228002listed patent expiry date: 2026-10-06pediatric extension
Patent 8022228003listed patent expiry date: 2026-10-06pediatric extension
NDA022117 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA022117 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA022117 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 marker0.001.002.002009-08-131.002026-04-061.002026-10-061.00

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.