grepcent public filings, reorganized for comparison

QELBREE — FDA application NDA211964

Application NDA211964 · type NDA · FDA status: approved · original approval 2021-04-02

Listed sponsor: SUPERNUS PHARMS · SUPN 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
001QELBREEVILOXAZINE HYDROCHLORIDECAPSULE, EXTENDED RELEASEORALEQ 100MG BASEPrescriptionnot listedYes
002QELBREEVILOXAZINE HYDROCHLORIDECAPSULE, EXTENDED RELEASEORALEQ 150MG BASEPrescriptionnot listedYes
003QELBREEVILOXAZINE HYDROCHLORIDECAPSULE, EXTENDED RELEASEORALEQ 200MG 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 11324753001listed patent expiry date: 2029-09-04U-727
Patent 11324753002listed patent expiry date: 2029-09-04U-727
Patent 11324753003listed patent expiry date: 2029-09-04U-727
Patent 11458143001listed patent expiry date: 2029-09-04U-727
Patent 11458143002listed patent expiry date: 2029-09-04U-727
Patent 11458143003listed patent expiry date: 2029-09-04U-727
Patent 12121523001listed patent expiry date: 2029-09-04U-727
Patent 12121523002listed patent expiry date: 2029-09-04U-727
Patent 12121523003listed patent expiry date: 2029-09-04U-727
Patent 9358204001listed patent expiry date: 2033-02-07drug product
Patent 9358204002listed patent expiry date: 2033-02-07drug product
Patent 9358204003listed patent expiry date: 2033-02-07drug product
Patent 9603853001listed patent expiry date: 2033-02-07U-727
Patent 9603853002listed patent expiry date: 2033-02-07U-727
Patent 9603853003listed patent expiry date: 2033-02-07U-727
Patent 9662338001listed patent expiry date: 2035-04-02drug product
Patent 9662338002listed patent expiry date: 2035-04-02drug product
Patent 9662338003listed patent expiry date: 2035-04-02drug product
Exclusivity NCE001listed exclusivity date: 2026-04-02FDA code as listed
Exclusivity NCE002listed exclusivity date: 2026-04-02FDA code as listed
Exclusivity NCE003listed exclusivity date: 2026-04-02FDA code as listed
NDA211964 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA211964 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA211964 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 marker0.001.002.002021-04-021.002026-04-021.002029-09-041.002033-02-071.002035-04-021.00

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: No published peer-cluster link for this sponsor.

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.