Corticotropin - Generic Drug Details

What are the generic sources for corticotropin and what is the scope of freedom to operate?

Corticotropin is the generic ingredient in seven branded drugs marketed by Parkedale, Sanofi Aventis Us, Mallinckrodt Ireland, Organics Lagrange, Watson Labs, and Ani Pharms, and is included in seven NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for corticotropin

US Patents:	6
Tradenames:	7
Applicants:	6
NDAs:	7
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	58
Patent Applications:	5,388
DailyMed Link:	corticotropin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for corticotropin

Constraining patent/regulatory exclusivity:

11,752,199

Dosage:

INJECTABLE;INJECTION

Constraining patent/regulatory exclusivity:

12,324,787

Dosage:

INJECTABLE;INJECTION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for corticotropin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Corteria Pharmaceuticals	PHASE2
Worldwide Clinical Trials	PHASE2
Rutgers, The State University of New Jersey	Phase 2

See all corticotropin clinical trials

Pharmacology for corticotropin

Drug Class

Adrenocorticotropic Hormone

Anatomical Therapeutic Chemical (ATC) Classes for corticotropin

H01AA	ACTH
H01A	ANTERIOR PITUITARY LOBE HORMONES AND ANALOGUES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for corticotropin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes	12,102,662
Ani Pharms	PURIFIED CORTROPHIN GEL	corticotropin	INJECTABLE;INJECTION	008975-001	Approved Prior to Jan 1, 1982		DISCN	No	No	12,102,662
Parkedale	ACTH	corticotropin	INJECTABLE;INJECTION	008317-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Sanofi Aventis Us	ACTHAR	corticotropin	INJECTABLE;INJECTION	007504-003	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt Ireland	ACTHAR GEL (AUTOINJECTOR)	corticotropin	INJECTABLE;INJECTION	008372-004	Feb 29, 2024		RX	Yes	Yes	11,752,199
Sanofi Aventis Us	ACTHAR	corticotropin	INJECTABLE;INJECTION	007504-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Mallinckrodt Ireland	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372-008	Approved Prior to Jan 1, 1982		RX	Yes	Yes	11,752,199