grepcent public filings, reorganized for comparison

DAKLINZA — FDA application NDA206843

Application NDA206843 · type NDA · FDA status: approved · original approval 2015-07-24

Listed sponsor: BRISTOL-MYERS SQUIBB · BMY 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
001DAKLINZADACLATASVIR DIHYDROCHLORIDETABLETORALEQ 30MG BASEDiscontinuednot listedYes
002DAKLINZADACLATASVIR DIHYDROCHLORIDETABLETORALEQ 60MG BASEDiscontinuednot listedYes
003DAKLINZADACLATASVIR DIHYDROCHLORIDETABLETORALEQ 90MG BASEDiscontinuednot 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 8900566001listed patent expiry date: 2027-08-08U-1725
Patent 8900566001listed patent expiry date: 2027-08-08U-1724
Patent 8900566002listed patent expiry date: 2027-08-08U-1725
Patent 8900566002listed patent expiry date: 2027-08-08U-1724
Patent 9421192001listed patent expiry date: 2027-08-08drug substance, U-1725
Patent 9421192001listed patent expiry date: 2027-08-08drug substance, U-1724
Patent 9421192002listed patent expiry date: 2027-08-08drug substance, U-1725
Patent 9421192002listed patent expiry date: 2027-08-08drug substance, U-1724
Patent 9421192003listed patent expiry date: 2027-08-08drug substance, U-1725
Patent 9421192003listed patent expiry date: 2027-08-08drug substance, U-1724
Patent 8642025001listed patent expiry date: 2027-08-11drug substance, drug product, U-1724
Patent 8642025001listed patent expiry date: 2027-08-11drug substance, drug product, U-1725
Patent 8642025002listed patent expiry date: 2027-08-11drug substance, drug product, U-1724
Patent 8642025002listed patent expiry date: 2027-08-11drug substance, drug product, U-1725
Patent 8329159001listed patent expiry date: 2029-07-24drug substance
Patent 8329159002listed patent expiry date: 2029-07-24drug substance
Patent 8629171001listed patent expiry date: 2031-06-13drug substance, drug product, U-1724
Patent 8629171002listed patent expiry date: 2031-06-13drug substance, drug product, U-1724
NDA206843 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA206843 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA206843 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 marker0.001.002.002015-07-241.002027-08-081.002027-08-111.002029-07-241.002031-06-131.00

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.