PURIFIED CORTROPHIN GEL — FDA application NDA008975
Listed sponsor: ANI PHARMS · ANIP 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
| 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 |
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
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3904 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3905 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3906 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3907 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3908 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3909 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3910 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3911 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3912 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3913 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3914 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3915 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3916 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3917 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3918 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3919 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3920 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3921 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3922 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3923 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3924 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3925 |
| Patent 11975047 | 002 | listed patent expiry date: 2043-10-27 | U-3926 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3917 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3918 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3919 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3920 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3921 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3922 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3923 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3924 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3925 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3926 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3904 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3905 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3906 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3907 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3908 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3909 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3910 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3911 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3912 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3913 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3914 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3915 |
| Patent 12102662 | 001 | listed patent expiry date: 2043-10-27 | U-3916 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3916 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3917 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3918 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3919 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3920 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3921 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3922 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3923 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3924 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3925 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3926 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3904 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3905 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3906 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3907 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3908 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3909 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3910 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3911 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3912 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3913 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3914 |
| Patent 12102662 | 002 | listed patent expiry date: 2043-10-27 | U-3915 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3912 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3913 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3914 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3915 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3916 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3917 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3918 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3919 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3920 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3921 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3922 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3923 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3924 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3925 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3926 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3904 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3905 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3906 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3907 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3908 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3909 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3910 |
| Patent 12233105 | 002 | listed patent expiry date: 2043-10-27 | U-3911 |
| Patent 12324787 | 002 | listed patent expiry date: 2043-10-27 | drug product |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3910 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3911 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3904 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3905 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3906 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3907 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3908 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3909 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3912 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3913 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3914 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3915 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3916 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3917 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3918 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3919 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3920 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3921 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3922 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3923 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3924 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3925 |
| Patent 12440542 | 002 | listed patent expiry date: 2043-10-27 | drug product, U-3926 |
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 · 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.