grepcent public filings, reorganized for comparison

RYTELO — FDA application NDA217779

Application NDA217779 · type NDA · FDA status: approved · original approval 2024-06-06

Listed sponsor: GERON · GERN 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
001RYTELOIMETELSTAT SODIUMPOWDERINTRAVENOUSEQ 47MG BASE/VIALPrescriptionnot listedYes
002RYTELOIMETELSTAT SODIUMPOWDERINTRAVENOUSEQ 188MG BASE/VIALPrescriptionnot 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 9388415001listed patent expiry date: 2026-09-09U-3956
Patent 9388415002listed patent expiry date: 2026-09-09U-3956
Patent 9388416001listed patent expiry date: 2026-09-09U-3956
Patent 9388416002listed patent expiry date: 2026-09-09U-3956
Patent 7494982001listed patent expiry date: 2026-12-27drug substance, drug product
Patent 7494982002listed patent expiry date: 2026-12-27drug substance, drug product
Patent 12442000001listed patent expiry date: 2033-03-15U-3956
Patent 12442000002listed patent expiry date: 2033-03-15U-3956
Patent 9375485001listed patent expiry date: 2033-03-15U-3956
Patent 9375485002listed patent expiry date: 2033-03-15U-3956
Patent 12171778001listed patent expiry date: 2039-06-16U-3956
Patent 12171778002listed patent expiry date: 2039-06-16U-3956
Exclusivity ODE-482001listed exclusivity date: 2031-06-06FDA code as listed
Exclusivity ODE-482002listed exclusivity date: 2031-06-06FDA code as listed
NDA217779 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA217779 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA217779 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 marker0.001.002.002024-06-061.002026-09-091.002026-12-271.002031-06-061.002033-03-151.002039-06-161.00

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: 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.