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
Pharmacia And Upjohn	NEO-CORTEF	hydrocortisone acetate; neomycin sulfate	OINTMENT;TOPICAL	060751-003	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ferndale Labs	PRAMOSONE	hydrocortisone acetate; pramoxine hydrochloride	LOTION;TOPICAL	083213-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ingram Pharm	DRICORT	hydrocortisone acetate	LOTION;TOPICAL	086207-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Monarch Pharms	CORTISPORIN	hydrocortisone acetate; neomycin sulfate; polymyxin b sulfate	CREAM;TOPICAL	050218-001	Aug 9, 1985		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pfizer	CORTRIL	hydrocortisone acetate	INJECTABLE;INJECTION	009164-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bel Mar	HYDROCORTISONE ACETATE	hydrocortisone acetate	INJECTABLE;INJECTION	083739-001	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