grepcent public filings, reorganized for comparison

IDHIFA — FDA application NDA209606

Application NDA209606 · type NDA · FDA status: approved · original approval 2017-08-01

Listed sponsor: BRISTOL MYERS SQUIBB · BMY 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
001IDHIFAENASIDENIB MESYLATETABLETORALEQ 50MG BASEPrescriptionnot listedYes
002IDHIFAENASIDENIB MESYLATETABLETORALEQ 100MG 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 10610125001listed patent expiry date: 2030-06-21U-2087
Patent 10610125002listed patent expiry date: 2030-06-21U-2087
Patent 10294215001listed patent expiry date: 2033-01-07drug product, U-2087
Patent 10294215002listed patent expiry date: 2033-01-07drug product, U-2087
Patent 9512107001listed patent expiry date: 2033-01-07drug substance, drug product, U-2087
Patent 9512107002listed patent expiry date: 2033-01-07drug substance, drug product, U-2087
Patent 10093654001listed patent expiry date: 2034-08-01drug substance, drug product, U-2087
Patent 10093654002listed patent expiry date: 2034-08-01drug substance, drug product, U-2087
Patent 9738625001listed patent expiry date: 2034-08-01drug substance
Patent 9738625002listed patent expiry date: 2034-08-01drug substance
Patent 9732062001listed patent expiry date: 2034-09-16drug substance
Patent 9732062002listed patent expiry date: 2034-09-16drug substance
NDA209606 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA209606 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA209606 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 marker0.001.002.002017-08-011.002030-06-211.002033-01-071.002034-08-011.002034-09-161.00

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.