grepcent public filings, reorganized for comparison

MAVYRET — FDA application NDA209394

Application NDA209394 · type NDA · FDA status: approved · original approval 2017-08-03

Listed sponsor: ABBVIE · ABBV 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
001MAVYRETGLECAPREVIR; PIBRENTASVIRTABLETORAL100MG;40MGPrescriptionnot 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 10028937001listed patent expiry date: 2030-06-10U-4206
Patent 10028937001listed patent expiry date: 2030-06-10U-2141
Patent 10028937001listed patent expiry date: 2030-06-10U-3237
Patent 10039754001listed patent expiry date: 2030-06-10U-2141
Patent 10039754001listed patent expiry date: 2030-06-10U-4206
Patent 10039754001listed patent expiry date: 2030-06-10U-3237
Patent 9586978001listed patent expiry date: 2030-11-06U-4206
Patent 9586978001listed patent expiry date: 2030-11-06U-3237
Patent 9586978001listed patent expiry date: 2030-11-06U-2141
Patent 10028937001listed patent expiry date: 2030-12-10pediatric extension
Patent 10039754001listed patent expiry date: 2030-12-10pediatric extension
Patent 9586978001listed patent expiry date: 2031-05-06pediatric extension
Patent 8648037001listed patent expiry date: 2032-01-19drug substance, drug product, U-2141
Patent 8648037001listed patent expiry date: 2032-01-19drug substance, drug product, U-4206
Patent 8648037001listed patent expiry date: 2032-01-19drug substance, drug product, U-3237
Patent 8937150001listed patent expiry date: 2032-05-18drug substance, drug product
Patent 8648037001listed patent expiry date: 2032-07-19pediatric extension
Patent 8937150001listed patent expiry date: 2032-11-18pediatric extension
Patent 10286029001listed patent expiry date: 2034-03-14U-4206
Patent 10286029001listed patent expiry date: 2034-03-14U-3237
Patent 11484534001listed patent expiry date: 2034-03-14U-4206
Patent 11484534001listed patent expiry date: 2034-03-14U-3237
Patent 10286029001listed patent expiry date: 2034-09-14pediatric extension
Patent 11484534001listed patent expiry date: 2034-09-14pediatric extension
Patent RE48923001listed patent expiry date: 2035-05-08drug substance
Patent 9321807001listed patent expiry date: 2035-06-05drug substance
Patent RE48923001listed patent expiry date: 2035-11-08pediatric extension
Patent 9321807001listed patent expiry date: 2035-12-05pediatric extension
Patent 11246866001listed patent expiry date: 2036-06-24drug product
Patent 11246866001listed patent expiry date: 2036-12-24pediatric extension
Exclusivity ODE-232001listed exclusivity date: 2026-04-30FDA code as listed
Exclusivity ODE-233001listed exclusivity date: 2026-04-30FDA code as listed
Exclusivity PED001listed exclusivity date: 2026-10-30FDA code as listed
Exclusivity PED001listed exclusivity date: 2026-10-30FDA code as listed
Exclusivity I-967001listed exclusivity date: 2028-06-10FDA code as listed
Exclusivity ODE-372001listed exclusivity date: 2028-06-10FDA code as listed
Exclusivity PED001listed exclusivity date: 2028-12-10FDA code as listed
NDA209394 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA209394 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA209394 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 marker0.001.002.00

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.