Is there a generic for Lorazepam?

Yes. The FDA Orange Book lists 69 approved generic (ANDA) applications for Lorazepam, referencing the brand LOREEV XR. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lorazepam?

LOREEV XR (NDA 214826, ALMATICA) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Lorazepam?

The Orange Book lists 1 patent against Lorazepam products, with the earliest listed expiry in 2034. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Lorazepam are approved?

Lorazepam is approved in the following dosage forms: capsule, extended release, concentrate, injectable, solution, tablet.

FDA Orange Book · active-ingredient family

Lorazepam

Lorazepam: 3 brands, 69 generics; first approved Aug 09, 1985; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 69 ANDA applications approved.

Earliest patent expiry Jan 08, 2034

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 08, 2034

in 7 yr 4 mo

Brand (NDA) products

Originator applications

LOREEV XRRLD

ALMATICANDA 21482620214 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	—
2MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	—
3MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	—
1.5MG	CAPSULE, EXTENDED RELEASE	ORAL	Rx	—

ATIVANRLDRS
HIKMANDA 018140—2 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Rx AP
4MG/ML INJECTABLE INJECTION Rx AP
ATIVANRLD
BAUSCHNDA 017794—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	INJECTABLE	INJECTION	Rx	AP
4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Generic (ANDA) products (69)

Abbreviated applications

LORAZEPAM
GRAVITI PHARMSANDA 21859720253 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
LORAZEPAM
FRESENIUS KABI USAANDA 2175982024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Rx AP
LORAZEPAM
AUROBINDO PHARMAANDA 20357220173 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
LORAZEPAM
RISINGANDA 20054220172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
RISINGANDA 20021720172 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
LUPIN LTDANDA 0914072013
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML CONCENTRATE ORAL Discontinued —
LORAZEPAM
HIKMAANDA 2001692012
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML CONCENTRATE ORAL Discontinued —
LORAZEPAM
AMNEAL PHARMSANDA 07882620103 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
1MG TABLET ORAL Discontinued —
2MG TABLET ORAL Discontinued —
LORAZEPAM
PHARM ASSOCANDA 0902602010
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML CONCENTRATE ORAL Rx AA
LORAZEPAM
AMNEAL PHARMSANDA 0913832009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML CONCENTRATE ORAL Rx AA
LORAZEPAM
CHARTWELL MOLECULARANDA 0792442009
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML CONCENTRATE ORAL Discontinued —
LORAZEPAM
LEADINGANDA 07820320073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
LORAZEPAM
ANI PHARMSANDA 07739620063 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
LORAZEPAM
OXFORD PHARMSANDA 07775420063 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
LORAZEPAM
RISINGANDA 07765720063 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
1MG TABLET ORAL Discontinued —
2MG TABLET ORAL Discontinued —
LORAZEPAM
BEDFORDANDA 07707620052 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM PRESERVATIVE FREE
BEDFORD LABSANDA 07707420052 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
INTL MEDICATION SYSANDA 0761502004
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Rx AP
LORAZEPAM
SUN PHARM INDS LTDANDA 07604520013 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
2MG TABLET ORAL Rx AB
LORAZEPAM
PH HEALTHANDA 07479320002 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
HIKMAANDA 07449619982 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
EPIC PHARMA LLCANDA 0749741998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
RISINGANDA 0750251998
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Rx AP
LORAZEPAM
ROXANEANDA 0746481997
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG/5ML SOLUTION ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	CONCENTRATE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	CONCENTRATE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	CONCENTRATE	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	CONCENTRATE	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	CONCENTRATE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—
1MG	TABLET	ORAL	Discontinued	—
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG/5ML	SOLUTION	ORAL	Discontinued	—

LORAZEPAM

CAPLINANDA 07455119963 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	INJECTABLE	INJECTION	Discontinued	—
4MG/ML	INJECTABLE	INJECTION	Discontinued	—
1MG/0.5ML	INJECTABLE	INJECTION	Discontinued	—

LORAZEPAM
PHARMOBEDIENTANDA 07453519962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
HOSPIRAANDA 07428019942 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
HOSPIRAANDA 07428219942 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
WATSON LABSANDA 07427619942 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
HOSPIRAANDA 07424319942 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Rx AP
4MG/ML INJECTABLE INJECTION Rx AP
LORAZEPAM
HOSPIRAANDA 07430019942 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML INJECTABLE INJECTION Discontinued —
4MG/ML INJECTABLE INJECTION Discontinued —
LORAZEPAM
WATSON LABSANDA 0729261991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Rx AB
LORAZEPAM
WATSON LABSANDA 0729271991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Rx AB
LORAZEPAM
WATSON LABSANDA 0729281991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Rx AB
LORAZEPAM INTENSOLRS
HIKMAANDA 0727551991
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG/ML CONCENTRATE ORAL Rx AA
LORAZEPAM
TP ANDA HOLDINGSANDA 07255519913 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
0.5MG TABLET ORAL Discontinued —
1MG TABLET ORAL Discontinued —
LORAZEPAM
SANDOZANDA 0711931988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
LORAZEPAM
SANDOZANDA 0711941988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZEPAM
SANDOZANDA 0711951988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
LORAZEPAM
WARNER CHILCOTTANDA 0710381988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZEPAM
WARNER CHILCOTTANDA 0710391988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
LORAZEPAM
CHARTWELL RXANDA 07159119873 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
0.5MG TABLET ORAL Discontinued —
1MG TABLET ORAL Discontinued —
LORAZEPAM
HALSEYANDA 0714341987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
LORAZEPAM
HALSEYANDA 0714351987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZEPAM
HALSEYANDA 0714361987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
LORAZEPAM
SANDOZANDA 07114119873 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Rx AB
0.5MG TABLET ORAL Rx AB
1MG TABLET ORAL Rx AB
LORAZEPAM
WATSON LABSANDA 0710861987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
LORAZEPAM
WATSON LABSANDA 0710871987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZEPAM
WATSON LABSANDA 0710881987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
LORAZEPAM
SUPERPHARMANDA 0712451987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
LORAZEPAM
SUPERPHARMANDA 0712461987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZEPAM
SUPERPHARMANDA 0712471987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
LORAZEPAM
USL PHARMAANDA 0705391986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZEPAM
USL PHARMAANDA 0705401986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
LORAZEPAM
PAR PHARMANDA 0706751986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
LORAZEPAM
PAR PHARMANDA 0706761986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZEPAM
PAR PHARMANDA 0706771986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
LORAZEPAM
WATSON LABSANDA 0711171986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
LORAZEPAM
WATSON LABSANDA 0711181986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZEPAM
WATSON LABSANDA 0711101986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
LORAZEPAM
AM THERAPANDA 0707271986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
LORAZEPAM
AM THERAPANDA 0707281986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZEPAM
AM THERAPANDA 0707291986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
LORAZEPAM
MUTUAL PHARMANDA 0704721985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
LORAZEPAM
MUTUAL PHARMANDA 0704731985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZEPAM
MUTUAL PHARMANDA 0704741985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —
LORAZ
QUANTUM PHARMICSANDA 0702001985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.5MG TABLET ORAL Discontinued —
LORAZ
QUANTUM PHARMICSANDA 0702011985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG TABLET ORAL Discontinued —
LORAZ
QUANTUM PHARMICSANDA 0702021985
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
2MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	INJECTABLE	INJECTION	Rx	AP
4MG/ML	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG/ML	CONCENTRATE	ORAL	Rx	AA

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—
0.5MG	TABLET	ORAL	Discontinued	—
1MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—
0.5MG	TABLET	ORAL	Discontinued	—
1MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
2MG	TABLET	ORAL	Rx	AB
0.5MG	TABLET	ORAL	Rx	AB
1MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.5MG	TABLET	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8999393	Jan 08, 2034	in 7 yr 4 mo	ProductU-3210

Approval history

FDA approval span

First approval

Aug 09, 1985

41 yr 9 mo ago

Most recent approval

Jul 24, 2025

1 yr 3 mo ago

Approvals span 1985–2025 across 72 FDA applications.

Brand (NDA) 34%

Generic (ANDA) 6996%

Lorazepam: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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