CORTICOTROPIN - Generic Drug Details

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What are the generic sources for corticotropin and what is the scope of patent protection?

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

There are ten drug master file entries for corticotropin. Two suppliers are listed for this compound.

Sponsor	Phase
Rutgers, The State University of New Jersey	Phase 2
Yangzhou University	N/A
Feinstein Institute for Medical Research	Phase 2

Sponsor

Phase

Rutgers, The State University of New Jersey

Phase 2

Yangzhou University

N/A

Feinstein Institute for Medical Research

Phase 2

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organics Lagrange	CORTICOTROPIN	corticotropin	INJECTABLE;INJECTION	010831-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mallinckrodt Ard	ACTHAR GEL (AUTOINJECTOR)	corticotropin	INJECTABLE;INJECTION	008372-003	Feb 29, 2024		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	CORTROPHIN-ZINC	corticotropin-zinc hydroxide	INJECTABLE;INJECTION	009854-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Parkedale	ACTH	corticotropin	INJECTABLE;INJECTION	008317-004	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mallinckrodt Ard	ACTHAR GEL	corticotropin	INJECTABLE;INJECTION	008372-008	Approved Prior to Jan 1, 1982		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organics Lagrange	CORTICOTROPIN	corticotropin	INJECTABLE;INJECTION	010831-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	2
Tradenames:	7
Applicants:	6
NDAs:	7
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	19
Clinical Trials:	57
Patent Applications:	6,827
DailyMed Link:	CORTICOTROPIN at DailyMed