Dexamethasone acetate - Generic Drug Details

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

Dexamethasone acetate is the generic ingredient in two branded drugs marketed by Merck, Watson Labs, and Watson Labs Teva, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for dexamethasone acetate.

Summary for dexamethasone acetate

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	7
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	81
Patent Applications:	4,680
Formulation / Manufacturing:	see details
DailyMed Link:	dexamethasone acetate at DailyMed

Recent Clinical Trials for dexamethasone acetate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Assiut University	N/A
Antengene Corporation	Phase 1/Phase 2
Xia Zhongjun	Phase 1/Phase 2

See all dexamethasone acetate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for dexamethasone acetate

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

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

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XB	Corticosteroids, moderately potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D10AA	Corticosteroids, combinations for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE 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

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

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

S03BA	Corticosteroids
S03B	CORTICOSTEROIDS
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for dexamethasone acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	DEXAMETHASONE ACETATE	dexamethasone acetate	INJECTABLE;INJECTION	084315-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs Teva	DEXAMETHASONE ACETATE	dexamethasone acetate	INJECTABLE;INJECTION	087711-001	May 24, 1982		DISCN	No	No
Merck	DECADRON-LA	dexamethasone acetate	INJECTABLE;INJECTION	016675-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No