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
University Medical Center Groningen	Early Phase 1
Feinstein Institute for Medical Research	Phase 2
University of Michigan	Phase 2

Sponsor

Phase

University Medical Center Groningen

Early Phase 1

Feinstein Institute for Medical Research

Phase 2

University of Michigan

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
Mylan Speciality Lp	PROCTOFOAM HC	hydrocortisone acetate; pramoxine hydrochloride	AEROSOL, METERED;TOPICAL	086195-001	Approved Prior to Jan 1, 1982	BX	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	HYDROCORTISONE ACETATE	hydrocortisone acetate	INJECTABLE;INJECTION	083759-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	CORTRIL	hydrocortisone acetate	INJECTABLE;INJECTION	009164-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Merck	HYDROCORTONE	hydrocortisone acetate	OINTMENT;OPHTHALMIC, OTIC	009018-003	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pharmacia And Upjohn	NEO-CORTEF	hydrocortisone acetate; neomycin sulfate	OINTMENT;OPHTHALMIC	060610-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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:	19
Patent Applications:	6,486
Formulation / Manufacturing:	see details
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