ESTAZOLAM - Generic Drug Details

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

Estazolam is the generic ingredient in two branded drugs marketed by Dr Reddys Labs Sa, Novitium Pharma, Watson Labs, and Abbott, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for estazolam. Four suppliers are listed for this compound.

Summary for ESTAZOLAM

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	5
Patent Applications:	6,107
Drug Prices:	Drug price trends for ESTAZOLAM
What excipients (inactive ingredients) are in ESTAZOLAM?	ESTAZOLAM excipients list
DailyMed Link:	ESTAZOLAM at DailyMed

See drug prices for ESTAZOLAM

Recent Clinical Trials for ESTAZOLAM

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

Sponsor	Phase
The First Affiliated Hospital with Nanjing Medical University	N/A
The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine	Phase 4
Haitao Tu	Phase 4

See all ESTAZOLAM clinical trials

Pharmacology for ESTAZOLAM

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for ESTAZOLAM

Anti-Anxiety Agents

Anticonvulsants

GABA Modulators

Anatomical Therapeutic Chemical (ATC) Classes for ESTAZOLAM

N05CD	Benzodiazepine derivatives
N05C	HYPNOTICS AND SEDATIVES
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for ESTAZOLAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novitium Pharma	ESTAZOLAM	estazolam	TABLET;ORAL	074826-002	Jul 3, 1997	AB	RX	No	No
Watson Labs	ESTAZOLAM	estazolam	TABLET;ORAL	074818-002	Aug 19, 1997	AB	RX	No	No
Dr Reddys Labs Sa	ESTAZOLAM	estazolam	TABLET;ORAL	074921-002	Jul 10, 1997	AB	RX	No	Yes
Novitium Pharma	ESTAZOLAM	estazolam	TABLET;ORAL	074826-001	Jul 3, 1997	AB	RX	No	No
Dr Reddys Labs Sa	ESTAZOLAM	estazolam	TABLET;ORAL	074921-001	Jul 10, 1997	AB	RX	No	No
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-001	Dec 26, 1990		DISCN	Yes	No

Expired US Patents for ESTAZOLAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-001	Dec 26, 1990
Abbott	PROSOM	estazolam	TABLET;ORAL	019080-002	Dec 26, 1990