grepcent public filings, reorganized for comparison

TOVIAZ — FDA application NDA022030

Application NDA022030 · type NDA · FDA status: approved · original approval 2008-10-31

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
001TOVIAZFESOTERODINE FUMARATETABLET, EXTENDED RELEASEORAL4MGPrescriptionABYes
002TOVIAZFESOTERODINE FUMARATETABLET, EXTENDED RELEASEORAL8MGPrescriptionABYes

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 7807715001listed patent expiry date: 2027-06-07drug product, U-913
Patent 7807715002listed patent expiry date: 2027-06-07drug product, U-913
Patent 8088398001listed patent expiry date: 2027-06-07drug product, U-913
Patent 8088398002listed patent expiry date: 2027-06-07drug product, U-913
Patent 8501723001listed patent expiry date: 2027-06-07drug product
Patent 8501723002listed patent expiry date: 2027-06-07drug product
Patent 7807715001listed patent expiry date: 2027-12-07pediatric extension
Patent 7807715002listed patent expiry date: 2027-12-07pediatric extension
Patent 8088398001listed patent expiry date: 2027-12-07pediatric extension
Patent 8088398002listed patent expiry date: 2027-12-07pediatric extension
Patent 8501723001listed patent expiry date: 2027-12-07pediatric extension
Patent 8501723002listed patent expiry date: 2027-12-07pediatric extension
NDA022030 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA022030 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA022030 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 marker0.001.002.002008-10-311.002027-06-071.002027-12-071.00

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.