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)

3

Generics (ANDA)

69

Listed patents

1

Next patent expiry

Jan 08, 2034

in 7 yr 7 mo

Originator applications

Brand (NDA) products

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	—

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

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

Abbreviated applications

Generic (ANDA) products (69)

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

FRESENIUS KABI USAANDA 2175982024

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

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

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	—

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	—

LUPIN LTDANDA 0914072013

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

HIKMAANDA 2001692012

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

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	—

PHARM ASSOCANDA 0902602010

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

AMNEAL PHARMSANDA 0913832009

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

CHARTWELL MOLECULARANDA 0792442009

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

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

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

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

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	—

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	—

INTL MEDICATION SYSANDA 0761502004

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

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

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	—

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	—

EPIC PHARMA LLCANDA 0749741998

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

RISINGANDA 0750251998

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

ROXANEANDA 0746481997

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

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	—

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	—

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	—

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	—

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	—

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

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	—

WATSON LABSANDA 0729261991

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

WATSON LABSANDA 0729271991

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

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

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	—

SANDOZANDA 0711931988

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

SANDOZANDA 0711941988

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

SANDOZANDA 0711951988

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

WARNER CHILCOTTANDA 0710381988

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

WARNER CHILCOTTANDA 0710391988

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

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	—

HALSEYANDA 0714341987

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

HALSEYANDA 0714351987

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

HALSEYANDA 0714361987

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

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

WATSON LABSANDA 0710861987

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

WATSON LABSANDA 0710871987

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

WATSON LABSANDA 0710881987

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

SUPERPHARMANDA 0712451987

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

SUPERPHARMANDA 0712461987

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

SUPERPHARMANDA 0712471987

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

USL PHARMAANDA 0705391986

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

USL PHARMAANDA 0705401986

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

PAR PHARMANDA 0706751986

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

PAR PHARMANDA 0706761986

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

PAR PHARMANDA 0706771986

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

WATSON LABSANDA 0711171986

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

WATSON LABSANDA 0711181986

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

WATSON LABSANDA 0711101986

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

AM THERAPANDA 0707271986

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

AM THERAPANDA 0707281986

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

AM THERAPANDA 0707291986

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

MUTUAL PHARMANDA 0704721985

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

MUTUAL PHARMANDA 0704731985

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

MUTUAL PHARMANDA 0704741985

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

QUANTUM PHARMICSANDA 0702001985

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

QUANTUM PHARMICSANDA 0702011985

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

QUANTUM PHARMICSANDA 0702021985

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

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Orange Book patent file

Listed patents

Listed patents (1)

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 7 mo	ProductU-3210

FDA approval span

Approval history

First approval

Aug 09, 1985

41 yr 6 mo ago

Most recent approval

Jul 24, 2025

1 yr 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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