LORAZEPAM - Generic Drug Details

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

Lorazepam is the generic ingredient in six branded drugs marketed by Almatica, Amneal Pharms, Chartwell Molecular, Hikma, Lupin Ltd, Pharm Assoc, Bedford, Dr Reddys, Endo Operations, Epic Pharma Llc, Hospira, Intl Medication Sys, Rising, Watson Labs, Bedford Labs, Roxane, Bausch, Quantum Pharmics, Am Therap, Anda Repository, Ani Pharms, Aurolife Pharma Llc, Chartwell Rx, Halsey, Leading, Mutual Pharm, Oxford Pharms, Par Pharm, Sandoz, Sun Pharm Inds Ltd, Superpharm, Usl Pharma, and Warner Chilcott, and is included in seventy NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Lorazepam has thirty-five patent family members in thirty countries.

There are eleven drug master file entries for lorazepam. Thirty-seven suppliers are listed for this compound.

Summary for LORAZEPAM

International Patents:	35
US Patents:	1
Tradenames:	6
Applicants:	33
NDAs:	70
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	196
Patent Applications:	6,930
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for LORAZEPAM
Drug Sales Revenues:	Drug sales revenues for LORAZEPAM
What excipients (inactive ingredients) are in LORAZEPAM?	LORAZEPAM excipients list
DailyMed Link:	LORAZEPAM at DailyMed

See drug prices for LORAZEPAM

See drug sales revenues for LORAZEPAM

Recent Clinical Trials for LORAZEPAM

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

Sponsor	Phase
Children's Hospital Los Angeles	Phase 2
University of Colorado, Denver	Phase 2
University of Calgary	Phase 2

See all LORAZEPAM clinical trials

Pharmacology for LORAZEPAM

Drug Class

Benzodiazepine

Medical Subject Heading (MeSH) Categories for LORAZEPAM

Anti-Anxiety Agents

Anticonvulsants

Antiemetics

GABA Modulators

Hypnotics and Sedatives

Anatomical Therapeutic Chemical (ATC) Classes for LORAZEPAM

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for LORAZEPAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Am Therap	LORAZEPAM	lorazepam	TABLET;ORAL	070729-001	Mar 7, 1986		DISCN	No	No
Almatica	LOREEV XR	lorazepam	CAPSULE, EXTENDED RELEASE;ORAL	214826-004	Feb 16, 2022		RX	Yes	No			Y
Intl Medication Sys	LORAZEPAM	lorazepam	INJECTABLE;INJECTION	076150-001	Nov 15, 2004	AP	RX	No	No
Mutual Pharm	LORAZEPAM	lorazepam	TABLET;ORAL	070473-001	Dec 10, 1985		DISCN	No	No
Hospira	LORAZEPAM	lorazepam	INJECTABLE;INJECTION	074300-003	Mar 19, 1997		DISCN	No	No
Watson Labs	LORAZEPAM	lorazepam	TABLET;ORAL	072927-001	Oct 31, 1991	AB	RX	No	No
Ani Pharms	LORAZEPAM	lorazepam	TABLET;ORAL	077396-002	Dec 13, 2006		DISCN	No	No

Expired US Patents for LORAZEPAM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-001	Approved Prior to Jan 1, 1982
Hikma	ATIVAN	lorazepam	INJECTABLE;INJECTION	018140-002	Approved Prior to Jan 1, 1982

International Patents for LORAZEPAM

Country	Patent Number	Title	Estimated Expiration
Australia	2014205440	Sustained release formulations of lorazepam
Portugal	2943185
Poland	2943185
Cyprus	1123933
Hungary	E054005
Slovenia	2943185
Israel	239777	תכשירים רוקחיים בעלי שחרור מושהה של לוראזפאם (Sustained release formulations of lorazepam)