grepcent public filings, reorganized for comparison

COMETRIQ — FDA application NDA203756

Application NDA203756 · type NDA · FDA status: approved · original approval 2012-11-29

Listed sponsor: EXELIXIS · EXEL 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
001COMETRIQCABOZANTINIB S-MALATECAPSULEORALEQ 20MG BASEPrescriptionnot listedYes
002COMETRIQCABOZANTINIB S-MALATECAPSULEORALEQ 80MG 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 7579473001listed patent expiry date: 2026-08-14drug substance, drug product
Patent 7579473002listed patent expiry date: 2026-08-14drug substance, drug product
Patent 11091439001listed patent expiry date: 2030-01-15drug substance
Patent 11091439002listed patent expiry date: 2030-01-15drug substance
Patent 11091440001listed patent expiry date: 2030-01-15drug product
Patent 11091440002listed patent expiry date: 2030-01-15drug product
Patent 11098015001listed patent expiry date: 2030-01-15U-1617
Patent 11098015002listed patent expiry date: 2030-01-15U-1617
Patent 8877776001listed patent expiry date: 2030-10-08drug substance, drug product, U-1617
Patent 8877776002listed patent expiry date: 2030-10-08drug substance, drug product, U-1617
Patent 11298349001listed patent expiry date: 2032-02-10drug product
Patent 11298349002listed patent expiry date: 2032-02-10drug product
Patent 12128039001listed patent expiry date: 2032-02-10drug product, U-1617
Patent 12128039002listed patent expiry date: 2032-02-10drug product, U-1617
Patent 9717720001listed patent expiry date: 2032-02-10drug product
Patent 9717720002listed patent expiry date: 2032-02-10drug product
NDA203756 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA203756 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA203756 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 marker0.001.002.002012-11-291.002026-08-141.002030-01-151.002030-10-081.002032-02-101.00

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.