grepcent public filings, reorganized for comparison

VIVITROL — FDA application NDA021897

Application NDA021897 · type NDA · FDA status: approved · original approval 2006-04-13

Listed sponsor: ALKERMES · ALKS 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
001VIVITROLNALTREXONEFOR SUSPENSION, EXTENDED RELEASEINTRAMUSCULAR380MG/VIALPrescriptionnot 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 7919499001listed patent expiry date: 2029-10-15U-1124
Patent 7919499001listed patent expiry date: 2029-10-15U-1123
NDA021897 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA021897 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA021897 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 marker0.001.002.002006-04-131.002029-10-151.00

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: No published peer-cluster link for this sponsor.

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.