grepcent public filings, reorganized for comparison

IBRANCE — FDA application NDA207103

Application NDA207103 · type NDA · FDA status: approved · original approval 2015-02-03

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
001IBRANCEPALBOCICLIBCAPSULEORAL75MGPrescriptionnot listedYes
002IBRANCEPALBOCICLIBCAPSULEORAL100MGPrescriptionnot listedYes
003IBRANCEPALBOCICLIBCAPSULEORAL125MGPrescriptionnot 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 RE47739001listed patent expiry date: 2027-03-05drug substance, drug product
Patent RE47739002listed patent expiry date: 2027-03-05drug substance, drug product
Patent RE47739003listed patent expiry date: 2027-03-05drug substance, drug product
Patent RE47739001listed patent expiry date: 2027-09-05pediatric extension
Patent RE47739002listed patent expiry date: 2027-09-05pediatric extension
Patent RE47739003listed patent expiry date: 2027-09-05pediatric extension
Patent 10723730001listed patent expiry date: 2034-02-08drug substance, drug product
Patent 10723730002listed patent expiry date: 2034-02-08drug substance, drug product
Patent 10723730003listed patent expiry date: 2034-02-08drug substance, drug product
Patent 10723730001listed patent expiry date: 2034-08-08pediatric extension
Patent 10723730002listed patent expiry date: 2034-08-08pediatric extension
Patent 10723730003listed patent expiry date: 2034-08-08pediatric extension
Exclusivity M-14001listed exclusivity date: 2028-09-16FDA code as listed
Exclusivity M-14002listed exclusivity date: 2028-09-16FDA code as listed
Exclusivity M-14003listed exclusivity date: 2028-09-16FDA code as listed
Exclusivity PED001listed exclusivity date: 2029-03-16FDA code as listed
Exclusivity PED002listed exclusivity date: 2029-03-16FDA code as listed
Exclusivity PED003listed exclusivity date: 2029-03-16FDA code as listed
NDA207103 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA207103 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA207103 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 marker0.001.002.002015-02-031.002027-03-051.002027-09-051.002028-09-161.002029-03-161.002034-02-081.002034-08-081.00

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.