HYDROCORTISONE ACETATE - Generic Drug Details

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

Hydrocortisone acetate is the generic ingredient in nineteen branded drugs marketed by Mylan Speciality Lp, Fougera Pharms, Able, Cenci, Imperium, Parke Davis, Purepac Pharm, Sebela Ireland Ltd, Taro, Pharmacia And Upjohn, Pfizer, Bel Mar, Epic Pharma Llc, Watson Labs, Merck, Ingram Pharm, Fera Pharms, Colgate, X Gen Pharms, Monarch Pharms, Genus, and Ferndale Labs, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for hydrocortisone acetate. Two suppliers are listed for this compound.

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 1
Orion Corporation, Orion Pharma	Phase 1
University Medical Center Groningen	Early Phase 1

Sponsor

Phase

Merck Sharp & Dohme LLC

Phase 1

Orion Corporation, Orion Pharma

Phase 1

University Medical Center Groningen

Early Phase 1

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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
Taro	U-CORT	hydrocortisone acetate	CREAM;TOPICAL	089472-001	Jun 13, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sebela Ireland Ltd	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	083778-001	Approved Prior to Jan 1, 1982		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	COR-OTICIN	hydrocortisone acetate; neomycin sulfate	SUSPENSION/DROPS;OPHTHALMIC	060188-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sebela Ireland Ltd	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	CREAM;TOPICAL	085368-001	Approved Prior to Jan 1, 1982		RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Colgate	ORABASE HCA	hydrocortisone acetate	PASTE;TOPICAL	083205-001	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:	0
Tradenames:	19
Applicants:	22
NDAs:	40
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	20
Patent Applications:	7,082
Drug Prices:	Drug price trends for HYDROCORTISONE ACETATE
What excipients (inactive ingredients) are in HYDROCORTISONE ACETATE?	HYDROCORTISONE ACETATE excipients list
DailyMed Link:	HYDROCORTISONE ACETATE at DailyMed

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists