Is there a generic for Corticotropin?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Corticotropin, referencing the brand ACTHAR GEL. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Corticotropin?

ACTHAR GEL (NDA 008372, MALLINCKRODT IRELAND) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Corticotropin?

The Orange Book lists 6 patents against Corticotropin products, with the earliest listed expiry in 2041. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Corticotropin are approved?

Corticotropin is approved in the following dosage form: injectable.

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 Jul 18, 2041

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jul 18, 2041

in 14 yr 11 mo

Brand (NDA) products

Originator applications

Ask AI

ACTHAR GELRLDRS

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	-

PURIFIED CORTROPHIN GELRLDRS
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 -
ACTH
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 -
ACTHAR
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 -
CORTICOTROPIN
ORGANICS 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 -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40 UNITS/ML	INJECTABLE	INJECTION	Discontinued	-
80 UNITS/ML	INJECTABLE	INJECTION	Rx	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25 UNITS/VIAL	INJECTABLE	INJECTION	Discontinued	-
40 UNITS/VIAL	INJECTABLE	INJECTION	Discontinued	-

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
25 UNITS/VIAL	INJECTABLE	INJECTION	Discontinued	-
40 UNITS/VIAL	INJECTABLE	INJECTION	Discontinued	-

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

Ask AI

CORTICOTROPIN
WATSON LABSANDA 0887721984
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
40 UNITS/VIAL INJECTABLE INJECTION Discontinued -

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
40 UNITS/VIAL	INJECTABLE	INJECTION	Discontinued	-

Patent & exclusivity timeline

Protection horizon

Ask AI

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Ask AI

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11752199	Jul 18, 2041	in 14 yr 11 mo	U-3686
12102662	Oct 27, 2043	in 17 yr 3 mo	U-3917
12440542	Oct 27, 2043	in 17 yr 3 mo	ProductU-3910
12233105	Oct 27, 2043	in 17 yr 3 mo	U-3912
11975047	Oct 27, 2043	in 17 yr 3 mo	U-3904
12324787	Oct 27, 2043	in 17 yr 3 mo	Product

Approval history

FDA approval span

Ask AI

First approval

Nov 21, 1984

42 yr 6 mo ago

Most recent approval

Feb 29, 2024

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

Assyro Intelligence

Ask anything about Corticotropin

Cited answers from FDA, EMA, Health Canada, PubMed and ClinicalTrials.gov, in seconds. Free, no sign-up.

Evaluating for a team? Book a demo