Assyro AI

FDA Orange Book · active-ingredient family

Lorazepam

Lorazepam is approved as 3 brand and 69 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:LOREEV XR · NDA 214826

3

Brand (NDA)

69

Generics (ANDA)

1

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, concentrate, injectable, solution, tablet

ProductApplicantApplicationTEApproved
LOREEV XRRLD×4ALMATICANDA 214826—Aug 27, 2021
ATIVANRLD×2HIKMANDA 018140APApproved Prior to Jan 1, 1982
ATIVANRLD×3BAUSCHNDA 017794ABApproved Prior to Jan 1, 1982

Generic (ANDA) products (69)

ProductApplicantApplicationTEApproved
LORAZEPAM×3GRAVITI PHARMSANDA 218597ABJul 24, 2025
LORAZEPAMFRESENIUS KABI USAANDA 217598APNov 18, 2024
LORAZEPAM×3AUROBINDO PHARMAANDA 203572ABDec 22, 2017
LORAZEPAM×2RISINGANDA 200542—Apr 28, 2017
LORAZEPAM×2RISINGANDA 200217—Apr 04, 2017
LORAZEPAMLUPIN LTDANDA 091407—Feb 19, 2013
LORAZEPAMHIKMAANDA 200169—Jan 30, 2012
LORAZEPAM×3AMNEAL PHARMSANDA 078826—Jun 23, 2010
LORAZEPAMPHARM ASSOCANDA 090260AAJun 15, 2010
LORAZEPAMAMNEAL PHARMSANDA 091383AADec 23, 2009
LORAZEPAMCHARTWELL MOLECULARANDA 079244—Apr 28, 2009
LORAZEPAM×3LEADINGANDA 078203ABJul 30, 2007
LORAZEPAM×3ANI PHARMSANDA 077396ABDec 13, 2006
LORAZEPAM×3OXFORD PHARMSANDA 077754ABMay 10, 2006
LORAZEPAM×3RISINGANDA 077657—Mar 16, 2006
LORAZEPAM×2BEDFORDANDA 077076—Jul 13, 2005
LORAZEPAM PRESERVATIVE FREE×2BEDFORD LABSANDA 077074—Jul 13, 2005
LORAZEPAMINTL MEDICATION SYSANDA 076150APNov 15, 2004
LORAZEPAM×3SUN PHARM INDS LTDANDA 076045ABAug 29, 2001
LORAZEPAM×2PH HEALTHANDA 074793—Mar 16, 2000
LORAZEPAM×2HIKMAANDA 074496—Sep 28, 1998
LORAZEPAMEPIC PHARMA LLCANDA 074974—Jul 23, 1998
LORAZEPAMRISINGANDA 075025APJul 23, 1998
LORAZEPAMROXANEANDA 074648—Mar 18, 1997
LORAZEPAM×3CAPLINANDA 074551—Sep 12, 1996
LORAZEPAM×2PHARMOBEDIENTANDA 074535—Sep 12, 1996
LORAZEPAM×2HOSPIRAANDA 074280—May 27, 1994
LORAZEPAM×2HOSPIRAANDA 074282—May 27, 1994
LORAZEPAM×2WATSON LABSANDA 074276—Apr 15, 1994
LORAZEPAM×2HOSPIRAANDA 074243APApr 12, 1994
LORAZEPAM×2HOSPIRAANDA 074300—Apr 12, 1994
LORAZEPAMWATSON LABSANDA 072926ABOct 31, 1991
LORAZEPAMWATSON LABSANDA 072927ABOct 31, 1991
LORAZEPAMWATSON LABSANDA 072928ABOct 31, 1991
LORAZEPAM INTENSOLHIKMAANDA 072755AAJun 28, 1991
LORAZEPAM×3TP ANDA HOLDINGSANDA 072555—Mar 29, 1991
LORAZEPAMSANDOZANDA 071193—Apr 15, 1988
LORAZEPAMSANDOZANDA 071194—Apr 15, 1988
LORAZEPAMSANDOZANDA 071195—Apr 15, 1988
LORAZEPAMWARNER CHILCOTTANDA 071038—Jan 12, 1988
LORAZEPAMWARNER CHILCOTTANDA 071039—Jan 12, 1988
LORAZEPAM×3CHARTWELL RXANDA 071591—Oct 13, 1987
LORAZEPAMHALSEYANDA 071434—Sep 01, 1987
LORAZEPAMHALSEYANDA 071435—Sep 01, 1987
LORAZEPAMHALSEYANDA 071436—Sep 01, 1987
LORAZEPAM×3SANDOZANDA 071141ABApr 21, 1987
LORAZEPAMWATSON LABSANDA 071086—Mar 23, 1987
LORAZEPAMWATSON LABSANDA 071087—Mar 23, 1987
LORAZEPAMWATSON LABSANDA 071088—Mar 23, 1987
LORAZEPAMSUPERPHARMANDA 071245—Feb 09, 1987
LORAZEPAMSUPERPHARMANDA 071246—Feb 09, 1987
LORAZEPAMSUPERPHARMANDA 071247—Feb 09, 1987
LORAZEPAMUSL PHARMAANDA 070539—Dec 22, 1986
LORAZEPAMUSL PHARMAANDA 070540—Dec 22, 1986
LORAZEPAMPAR PHARMANDA 070675—Dec 01, 1986
LORAZEPAMPAR PHARMANDA 070676—Dec 01, 1986
LORAZEPAMPAR PHARMANDA 070677—Dec 01, 1986
LORAZEPAMWATSON LABSANDA 071117—Jul 24, 1986
LORAZEPAMWATSON LABSANDA 071118—Jul 24, 1986
LORAZEPAMWATSON LABSANDA 071110—Jul 24, 1986
LORAZEPAMAM THERAPANDA 070727—Mar 07, 1986
LORAZEPAMAM THERAPANDA 070728—Mar 07, 1986
LORAZEPAMAM THERAPANDA 070729—Mar 07, 1986
LORAZEPAMMUTUAL PHARMANDA 070472—Dec 10, 1985
LORAZEPAMMUTUAL PHARMANDA 070473—Dec 10, 1985
LORAZEPAMMUTUAL PHARMANDA 070474—Dec 10, 1985
LORAZQUANTUM PHARMICSANDA 070200—Aug 09, 1985
LORAZQUANTUM PHARMICSANDA 070201—Aug 09, 1985
LORAZQUANTUM PHARMICSANDA 070202—Aug 09, 1985

Listed patents (1)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8999393Jan 08, 2034in 7 yr 8 mo
ProductU-3210

Lorazepam — frequently asked questions

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

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