grepcent public filings, reorganized for comparison

VIEKIRA XR — FDA application NDA208624

Application NDA208624 · type NDA · FDA status: approved · original approval 2016-07-22

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
001VIEKIRA XRDASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIRTABLET, EXTENDED RELEASEORALEQ 200MG BASE;8.33MG;50MG;33.33MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**Discontinuednot listedYes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 8501238001listed patent expiry date: 2028-09-17drug substance, drug product, U-1636
Patent 9139536001listed patent expiry date: 2028-11-09U-1753
Patent 8188104001listed patent expiry date: 2029-05-17drug substance, drug product, U-1636
Patent 8642538001listed patent expiry date: 2029-09-10drug substance, drug product, U-1638
Patent 9006387001listed patent expiry date: 2030-06-10U-1687
Patent 8420596001listed patent expiry date: 2031-04-10drug substance, drug product
Patent 9044480001listed patent expiry date: 2031-04-10U-1638
Patent 8686026001listed patent expiry date: 2031-06-09drug product
Patent 8691938001listed patent expiry date: 2032-04-13drug substance, drug product
Patent 10201541001listed patent expiry date: 2032-05-17drug product
Patent 10201584001listed patent expiry date: 2032-05-17U-1889
Patent 8466159001listed patent expiry date: 2032-09-04U-1637
Patent 8492386001listed patent expiry date: 2032-09-04U-1840
Patent 8680106001listed patent expiry date: 2032-09-04U-1637
Patent 8685984001listed patent expiry date: 2032-09-04U-1840
Patent 10105365001listed patent expiry date: 2035-01-02drug product, U-1889
Patent 9333204001listed patent expiry date: 2035-01-02drug product, U-1889
Patent 9744170001listed patent expiry date: 2035-01-02drug product, U-1889
NDA208624 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208624 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA208624 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 marker0.001.002.002016-07-221.002028-09-171.002028-11-091.002029-05-171.002029-09-101.002030-06-101.002031-04-101.002031-06-091.002032-04-131.002032-05-171.002032-09-041.002035-01-021.00

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.