grepcent public filings, reorganized for comparison

REZLIDHIA — FDA application NDA215814

Application NDA215814 · type NDA · FDA status: approved · original approval 2022-12-01

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
001REZLIDHIAOLUTASIDENIBCAPSULEORAL150MGPrescriptionnot 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 10414752001listed patent expiry date: 2035-09-18drug product
Patent 10550098001listed patent expiry date: 2035-09-18drug product
Patent 11498913001listed patent expiry date: 2035-09-18drug product
Patent 12275715001listed patent expiry date: 2035-09-18drug substance, drug product, U-3684
Patent 9834539001listed patent expiry date: 2035-09-18drug substance, drug product, U-3497
Patent 10532047001listed patent expiry date: 2039-05-16drug substance
Patent 10959994001listed patent expiry date: 2039-05-16drug product
Patent 11013733001listed patent expiry date: 2039-05-16U-3496
Patent 11013734001listed patent expiry date: 2039-05-16U-3495
Patent 11376246001listed patent expiry date: 2039-05-16U-3495
Patent 11497743001listed patent expiry date: 2039-05-16U-3495
Patent 12053463001listed patent expiry date: 2039-05-16drug substance, drug product
Patent 11738018001listed patent expiry date: 2039-07-17U-3684
Patent 11723905001listed patent expiry date: 2039-11-12drug product
Exclusivity NCE001listed exclusivity date: 2027-12-01FDA code as listed
Exclusivity ODE-413001listed exclusivity date: 2029-12-01FDA code as listed
NDA215814 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215814 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215814 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 marker0.001.002.002022-12-011.002027-12-011.002029-12-011.002035-09-181.002039-05-161.002039-07-171.002039-11-121.00

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.