# PURIFIED CORTROPHIN GEL — FDA application NDA008975 Informational only - not investment advice. Application NDA008975 · type NDA · FDA status: approved · original approval 1954-06-16 Listed sponsor: ANI PHARMS · [ANIP company profile](/company/ANIP/) · exact_unique Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers. ## FDA application facts | Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD | | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 001 | PURIFIED CORTROPHIN GEL | CORTICOTROPIN | INJECTABLE | INJECTION | 40 UNITS/ML | Discontinued | not listed | No | | 002 | PURIFIED CORTROPHIN GEL | CORTICOTROPIN | INJECTABLE | INJECTION | 80 UNITS/ML | Prescription | not listed | Yes | ## Orange Book patent and exclusivity listings - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 11975047, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 001; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12102662, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12233105, product 002; listed patent expiry date: 2043-10-27. - Patent 12324787, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. - Patent 12440542, product 002; listed patent expiry date: 2043-10-27. 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 - CORTICOTROPIN · UNII K0U68Q2TXA · no lmmol compound match Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link. ## Related pages - [Sponsor company](/company/ANIP/) - [FDA-approved application index](/drug/) Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA008975. FDA data retrieved 2026-08-07. Regulatory listing data as published by FDA; not medical or investment advice.