grepcent public filings, reorganized for comparison

LORBRENA — FDA application NDA210868

Application NDA210868 · type NDA · FDA status: approved · original approval 2018-11-02

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
001LORBRENALORLATINIBTABLETORAL25MGPrescriptionnot listedYes
002LORBRENALORLATINIBTABLETORAL100MGPrescriptionnot 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 8680111001listed patent expiry date: 2033-03-05drug substance, drug product
Patent 8680111002listed patent expiry date: 2033-03-05drug substance, drug product
Patent 10420749001listed patent expiry date: 2036-07-27drug substance, drug product, U-2633
Patent 10420749001listed patent expiry date: 2036-07-27drug substance, drug product, U-3096
Patent 10420749002listed patent expiry date: 2036-07-27drug substance, drug product, U-2633
Patent 10420749002listed patent expiry date: 2036-07-27drug substance, drug product, U-3096
Patent 11020376001listed patent expiry date: 2036-07-27drug product
Patent 11020376002listed patent expiry date: 2036-07-27drug product
Patent 11299500001listed patent expiry date: 2038-10-04drug substance
Patent 11299500002listed patent expiry date: 2038-10-04drug substance
Exclusivity ODE-349001listed exclusivity date: 2028-03-03FDA code as listed
Exclusivity ODE-349002listed exclusivity date: 2028-03-03FDA code as listed
NDA210868 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA210868 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA210868 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 marker0.001.002.002018-11-021.002028-03-031.002033-03-051.002036-07-271.002038-10-041.00

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.