grepcent public filings, reorganized for comparison

FETZIMA — FDA application NDA204168

Application NDA204168 · type NDA · FDA status: approved · original approval 2013-07-25

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
001FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASEORALEQ 20MG BASEPrescriptionABYes
002FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASEORALEQ 40MG BASEPrescriptionABYes
003FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASEORALEQ 80MG BASEPrescriptionABYes
004FETZIMALEVOMILNACIPRAN HYDROCHLORIDECAPSULE, EXTENDED RELEASEORALEQ 120MG 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 RE43879001listed patent expiry date: 2026-01-11U-839
Patent RE43879002listed patent expiry date: 2026-01-11U-839
Patent RE43879003listed patent expiry date: 2026-01-11U-839
Patent RE43879004listed patent expiry date: 2026-01-11U-839
Patent 8481598001listed patent expiry date: 2031-03-02U-839
Patent 8481598002listed patent expiry date: 2031-03-02U-839
Patent 8481598003listed patent expiry date: 2031-03-02U-839
Patent 8481598004listed patent expiry date: 2031-03-02U-839
Patent 8865937001listed patent expiry date: 2032-05-23drug substance, drug product
Patent 8865937002listed patent expiry date: 2032-05-23drug substance, drug product
Patent 8865937003listed patent expiry date: 2032-05-23drug substance, drug product
Patent 8865937004listed patent expiry date: 2032-05-23drug substance, drug product
Exclusivity M-304001listed exclusivity date: 2026-03-24FDA code as listed
Exclusivity M-304002listed exclusivity date: 2026-03-24FDA code as listed
Exclusivity M-304003listed exclusivity date: 2026-03-24FDA code as listed
Exclusivity M-304004listed exclusivity date: 2026-03-24FDA code as listed
NDA204168 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA204168 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA204168 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 marker0.001.002.002013-07-251.002026-01-111.002026-03-241.002031-03-021.002032-05-231.00

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.