grepcent public filings, reorganized for comparison

VELSIPITY — FDA application NDA216956

Application NDA216956 · type NDA · FDA status: approved · original approval 2023-10-12

Listed sponsor: PFIZER · PFE 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
001VELSIPITYETRASIMOD ARGININETABLETORALEQ 2MG 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 9126932001listed patent expiry date: 2029-07-22U-3732
Patent 8580841001listed patent expiry date: 2030-03-05drug substance, drug product
Patent 11007175001listed patent expiry date: 2036-01-06U-3730
Patent 12156866001listed patent expiry date: 2036-01-06U-4047
Patent 12377071001listed patent expiry date: 2036-01-06U-4255
Patent 10301262001listed patent expiry date: 2036-06-21drug substance, drug product
Patent 10676435001listed patent expiry date: 2036-06-21U-3731
Patent 11091435001listed patent expiry date: 2036-06-21drug substance, drug product
Patent 11884626001listed patent expiry date: 2036-06-21U-3731
Exclusivity NCE001listed exclusivity date: 2028-10-12FDA code as listed
NDA216956 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA216956 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA216956 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 marker0.001.002.002023-10-121.002028-10-121.002029-07-221.002030-03-051.002036-01-061.002036-06-211.00

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.