FDA Orange Book · active-ingredient family
Corticotropin
Corticotropin: 5 brands, 1 generic; first approved Nov 21, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 1 ANDA application approved.
Earliest patent expiry
Brands (NDA)
5
Generics (ANDA)
1
Listed patents
6
Next patent expiry
Jul 18, 2041
in 15 yr
Brand (NDA) products
Originator applications
- MALLINCKRODT IRELANDNDA 008372—4 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40 UNITS/0.5ML INJECTABLE INJECTION Rx — 80 UNITS/ML INJECTABLE INJECTION Rx — 40 UNITS/ML INJECTABLE INJECTION Discontinued — 80 UNITS/ML INJECTABLE INJECTION Rx — - ANI PHARMSNDA 008975—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40 UNITS/ML INJECTABLE INJECTION Discontinued — 80 UNITS/ML INJECTABLE INJECTION Rx — - PARKEDALENDA 008317—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25 UNITS/VIAL INJECTABLE INJECTION Discontinued — 40 UNITS/VIAL INJECTABLE INJECTION Discontinued — - SANOFI AVENTIS USNDA 007504—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 25 UNITS/VIAL INJECTABLE INJECTION Discontinued — 40 UNITS/VIAL INJECTABLE INJECTION Discontinued — - CORTICOTROPINORGANICS LAGRANGENDA 010831—2 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40 UNITS/ML INJECTABLE INJECTION Discontinued — 80 UNITS/ML INJECTABLE INJECTION Discontinued —
Generic (ANDA) products (1)
Abbreviated applications
- CORTICOTROPINWATSON LABSANDA 0887721984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 40 UNITS/VIAL INJECTABLE INJECTION Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 11752199 | in 15 yr | U-3686 | |
| 12102662 | in 17 yr 4 mo | U-3917 | |
| 12440542 | in 17 yr 4 mo | ProductU-3910 | |
| 12233105 | in 17 yr 4 mo | U-3912 | |
| 11975047 | in 17 yr 4 mo | U-3904 | |
| 12324787 | in 17 yr 4 mo | Product |
Approval history
FDA approval span
First approval
42 yr 6 mo ago
Most recent approval
2 yr 8 mo ago
Approvals span 1984–2024 across 6 FDA applications.
Brand (NDA) 583%
Generic (ANDA) 117%
Corticotropin: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
