Hydrocortisone valerate - Generic Drug Details

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

Hydrocortisone valerate is the generic ingredient in two branded drugs marketed by Cosette, Encube Ethicals, Glenmark Pharms Ltd, Lupin Ltd, Padagis Israel, Taro, Sun Pharm Inds Inc, and Fougera Pharms, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for hydrocortisone valerate. Six suppliers are listed for this compound.

Summary for hydrocortisone valerate

US Patents:	0
Tradenames:	2
Applicants:	8
NDAs:	13
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	51
Patent Applications:	6,782
Drug Prices:	Drug price trends for hydrocortisone valerate
What excipients (inactive ingredients) are in hydrocortisone valerate?	hydrocortisone valerate excipients list
DailyMed Link:	hydrocortisone valerate at DailyMed

See drug prices for hydrocortisone valerate

Pharmacology for hydrocortisone valerate

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for hydrocortisone valerate

A01AC	Corticosteroids for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AA	Corticosteroids, weak (group I)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XA	Corticosteroids, weak, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01CB	Corticosteroids/antiinfectives/mydriatics in combination
S01C	ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02BA	Corticosteroids
S02B	CORTICOSTEROIDS
S02	OTOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for hydrocortisone valerate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cosette	HYDROCORTISONE VALERATE	hydrocortisone valerate	OINTMENT;TOPICAL	211764-001	Mar 4, 2020	AB	RX	No	No
Glenmark Pharms Ltd	HYDROCORTISONE VALERATE	hydrocortisone valerate	OINTMENT;TOPICAL	211750-001	Dec 14, 2018	AB	RX	No	No
Sun Pharm Inds Inc	WESTCORT	hydrocortisone valerate	OINTMENT;TOPICAL	018726-001	Aug 8, 1983		DISCN	Yes	No
Sun Pharm Inds Inc	WESTCORT	hydrocortisone valerate	CREAM;TOPICAL	017950-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Cosette	HYDROCORTISONE VALERATE	hydrocortisone valerate	CREAM;TOPICAL	213724-001	Feb 11, 2021	AB	RX	No	No