Acthar
Corticotropin
Sourced from the FDA Orange Book
Key dates
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Pharmaceutical detail
Active ingredient
CORTICOTROPIN
Strength
25 UNITS/VIAL
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 007504
Product number
002
Marketing status
Discontinued
Reference listed drug (RLD)
No
Reference standard (RS)
No
Other strengths in NDA 007504
Active-ingredient family
This is a brand (NDA) product. Other products sharing this active ingredient are listed below.
- —ActhBrand (NDA)
NDA 008317 · Parkedale
- —Acthar GelBrand (NDA)
NDA 008372 · Mallinckrodt Ireland
- —CorticotropinBrand (NDA)
NDA 010831 · Organics Lagrange
- —Purified Cortrophin GelBrand (NDA)
NDA 008975 · Ani Pharms
- 1984CorticotropinGeneric (ANDA)
ANDA 088772 · Watson Labs
Listed patents
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Acthar — frequently asked questions
Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.
Built directly from the FDA Orange Book data file. This product page links back to the Corticotropin active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsThe list of FDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 & Inspection DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
