Assyro AI

FDA Orange Book · active-ingredient family

Corticotropin

Corticotropin is approved as 5 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ACTHAR GEL · NDA 008372

5

Brand (NDA)

1

Generics (ANDA)

6

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable

ProductApplicantApplicationTEApproved
ACTHAR GELRLD×4MALLINCKRODT IRELANDNDA 008372—Approved Prior to Jan 1, 1982
PURIFIED CORTROPHIN GELRLD×2ANI PHARMSNDA 008975—Approved Prior to Jan 1, 1982
ACTH×2PARKEDALENDA 008317—Approved Prior to Jan 1, 1982
ACTHAR×2SANOFI AVENTIS USNDA 007504—Approved Prior to Jan 1, 1982
CORTICOTROPIN×2ORGANICS LAGRANGENDA 010831—Approved Prior to Jan 1, 1982

Generic (ANDA) products (1)

ProductApplicantApplicationTEApproved
CORTICOTROPINWATSON LABSANDA 088772—Nov 21, 1984

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
11752199Jul 18, 2041in 15 yr 4 mo
U-3686
12102662Oct 27, 2043in 17 yr 7 mo
U-3917
12440542Oct 27, 2043in 17 yr 7 mo
ProductU-3910
12233105Oct 27, 2043in 17 yr 7 mo
U-3912
11975047Oct 27, 2043in 17 yr 7 mo
U-3904
12324787Oct 27, 2043in 17 yr 7 mo
Product

Corticotropin — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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