grepcent public filings, reorganized for comparison

GAVRETO — FDA application NDA213721

Application NDA213721 · type NDA · FDA status: approved · original approval 2020-09-04

Listed sponsor: RIGEL PHARMS · RIGL 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
001GAVRETOPRALSETINIBCAPSULEORAL100MGPrescriptionnot 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 10030005001listed patent expiry date: 2036-11-01drug substance, drug product, U-2952
Patent 10030005001listed patent expiry date: 2036-11-01drug substance, drug product, U-3002
Patent 11273160001listed patent expiry date: 2039-04-03U-2952
Patent 11872192001listed patent expiry date: 2039-04-03U-2952
Patent 11963958001listed patent expiry date: 2039-04-03U-2828
Patent 12539303001listed patent expiry date: 2039-04-03U-2828
Patent 12448366001listed patent expiry date: 2042-07-07drug substance
Exclusivity ODE-318001listed exclusivity date: 2027-09-04FDA code as listed
Exclusivity ODE-340001listed exclusivity date: 2027-12-01FDA code as listed
Exclusivity ODE-341001listed exclusivity date: 2027-12-01FDA code as listed
NDA213721 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA213721 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA213721 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 marker0.001.002.002020-09-041.002027-09-041.002027-12-011.002036-11-011.002039-04-031.002042-07-071.00

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.