Assyro AI

FDA Orange Book · active-ingredient family

Lidocaine hydrochloride

Lidocaine hydrochloride is approved as 22 brand and 94 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:AKTEN · NDA 022221

22

Brand (NDA)

94

Generics (ANDA)

4

Listed patents

0

Exclusivity periods

Brand (NDA) products · gel, injectable, jelly, solution, system

ProductApplicantApplicationTEApproved
AKTENRLDTHEA PHARMANDA 022221—Oct 07, 2008
XYLOCAINE PRESERVATIVE FREERLD×5FRESENIUS KABI USANDA 016801—Jan 19, 1988
XYLOCAINERLD×4FRESENIUS KABI USANDA 006488APApproved Prior to Jan 1, 1982
XYLOCAINE 4% PRESERVATIVE FREERLD×2FRESENIUS KABI USANDA 010417—Approved Prior to Jan 1, 1982
XYLOCAINERLDEPIC PHARMA LLCNDA 008816—Approved Prior to Jan 1, 1982
XYLOCAINE VISCOUSRLDFRESENIUS KABI USANDA 009470—Approved Prior to Jan 1, 1982
ZINGOPOWDER PHARMSNDA 022114—Aug 16, 2007
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER×3B BRAUNNDA 019830APApr 08, 1992
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINERABBOTTNDA 018954—Jul 09, 1985
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER×3B BRAUNNDA 018967—Mar 30, 1984
XYLOCAINE 5% W/ GLUCOSE 7.5%ASTRAZENECANDA 010496—Jul 07, 1982
LIDOCAINE HYDROCHLORIDE×3ABRAXIS PHARMNDA 017508—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2INTL MEDICATIONNDA 017701—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2INTL MEDICATIONNDA 018543—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER×4BAXTER HLTHCARENDA 018461—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER×3HOSPIRANDA 018388—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE×2FRESENIUS KABI USANDA 017584APApproved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE×2INTL MEDICATIONNDA 017702—Approved Prior to Jan 1, 1982
LIDOPENMERIDIAN MEDCL TECHNNDA 017549—Approved Prior to Jan 1, 1982
XYLOCAINE×3ASTRAZENECANDA 010418—Approved Prior to Jan 1, 1982
XYLOCAINE DENTALDENTSPLY PHARMNDA 021380—Approved Prior to Jan 1, 1982
XYLOCAINE 1.5% W/ DEXTROSE 7.5%FRESENIUS KABI USANDA 016297—Approved Prior to Jan 1, 1982

Generic (ANDA) products (94)

ProductApplicantApplicationTEApproved
LIDOCAINE HYDROCHLORIDEQUAGENANDA 218676ATMar 20, 2026
LIDOCAINE HYDROCHLORIDE×2VIWIT PHARMANDA 220071APMar 19, 2026
LIDOCAINE HYDROCHLORIDEAUROBINDO PHARMA LTDANDA 219759ATJul 29, 2025
LIDOCAINE HYDROCHLORIDE×2ANTHEA PHARMAANDA 219535APApr 02, 2025
LIDOCAINE HYDROCHLORIDETHE J MOLNERANDA 218411ATApr 29, 2024
LIDOCAINE HYDROCHLORIDE VISCOUSPAI HOLDINGS PHARMANDA 218138ATFeb 20, 2024
LIDOCAINE HYDROCHLORIDESUN PHARMA CANADAANDA 218182ATDec 07, 2023
LIDOCAINE HYDROCHLORIDE×2MANKIND PHARMAANDA 217693APJul 11, 2023
LIDOCAINE HYDROCHLORIDE×3MANKIND PHARMAANDA 217692APJun 16, 2023
LIDOCAINE HYDROCHLORIDERUBICON RESEARCHANDA 216780ATMar 28, 2023
LIDOCAINE HYDROCHLORIDE×2YILINGANDA 214267APSep 19, 2022
LIDOCAINE HYDROCHLORIDEAFAXYSANDA 215132APJun 09, 2022
LIDOCAINE HYDROCHLORIDEYILINGANDA 214269APMay 05, 2022
LIDOCAINE HYDROCHLORIDENOVITIUM PHARMAANDA 216250ATMar 23, 2022
LIDOCAINE HYDROCHLORIDE×2ASPIROANDA 214336APNov 08, 2021
LIDOCAINE HYDROCHLORIDE×2ASPIROANDA 214339APNov 08, 2021
LIDOCAINE HYDROCHLORIDE×2HUONSANDA 212821APMay 07, 2020
LIDOCAINE HYDROCHLORIDEB BRAUN MEDICALANDA 208474APAug 03, 2018
LIDOCAINE HYDROCHLORIDESPECTRA MDCL DEVICESANDA 208017APApr 18, 2018
LIDOCAINE HYDROCHLORIDE×2EUGIA PHARMAANDA 207182APOct 30, 2017
LIDOCAINE HYDROCHLORIDEAM REGENTANDA 091564—Aug 14, 2015
GLYDOSAGENT PHARMS INCANDA 201094ATApr 28, 2014
LIDOCAINE HYDROCHLORIDERISINGANDA 202242—Apr 11, 2014
LIDOCAINE HYDROCHLORIDEPAI HOLDINGS PHARMANDA 204494ATMar 12, 2014
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE×2EUGIA PHARMAANDA 203040—Mar 14, 2013
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE×2EUGIA PHARMAANDA 203082APMar 14, 2013
LIDOCAINE HYDROCHLORIDEWATSON LABS INCANDA 040837—Mar 23, 2011
LIDOCAINE HYDROCHLORIDE×2RISINGANDA 091056—Dec 08, 2010
LIDOCAINE HYDROCHLORIDE×2RISINGANDA 091058—Sep 30, 2010
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREECHARTWELL RXANDA 090665—Sep 27, 2010
LIDOCAINE HYDROCHLORIDE VISCOUSCHARTWELL MOLECULARANDA 040708ATFeb 27, 2007
LIDOCAINE HYDROCHLORIDELANNETT CO INCANDA 040710ATFeb 27, 2007
LIDOCAINE HYDROCHLORIDESENTISSANDA 040433ATFeb 12, 2003
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER×2HOSPIRAANDA 040302APSep 28, 1998
LIDOCAINE HYDROCHLORIDEHIKMAANDA 040014—Jul 10, 1995
LIDOCAINE HYDROCHLORIDEHOSPIRAANDA 040013—Jun 23, 1995
LIDOCAINE HYDROCHLORIDEHOSPIRAANDA 040078APJun 23, 1995
LIDOCAINE HYDROCHLORIDECOSETTEANDA 081318—Apr 29, 1993
LIDOCAINE HYDROCHLORIDEPACOANDA 089688—Jun 30, 1989
LIDOCAINE HYDROCHLORIDEABBOTTANDA 089362—May 25, 1988
LIDOCAINE VISCOUSHIKMAANDA 088802ATApr 26, 1985
LIDOCAINE HYDROCHLORIDEHIKMAANDA 088803ATApr 03, 1985
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERHOSPIRAANDA 088325APJul 31, 1984
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERHOSPIRAANDA 088299APJul 31, 1984
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERHOSPIRAANDA 088326—Jul 31, 1984
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERHOSPIRAANDA 088327APJul 31, 1984
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERHOSPIRAANDA 088367—Jul 31, 1984
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINERHOSPIRAANDA 088368—Jul 31, 1984
LTA II KITHOSPIRAANDA 088542—Jul 31, 1984
PEDIATRIC LTA KITABBOTTANDA 088572—Jul 31, 1984
LIDOCAINE HYDROCHLORIDEHOSPIRAANDA 088328APMay 17, 1984
LIDOCAINE HYDROCHLORIDEHOSPIRAANDA 088329APMay 17, 1984
LIDOCAINE HYDROCHLORIDEHOSPIRAANDA 088330—May 17, 1984
LIDOCAINE HYDROCHLORIDEHOSPIRAANDA 088294APMay 17, 1984
LIDOCAINE HYDROCHLORIDEHOSPIRAANDA 088331—May 17, 1984
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREEHOSPIRAANDA 088295APMay 17, 1984
LIDOCATONPHARMATONANDA 084727—Aug 17, 1983
LARYNGOTRACHEAL ANESTHESIA KITKENDALL ILANDA 087931—Jun 10, 1983
LIDOCAINE HYDROCHLORIDEABBOTTANDA 087980—Feb 02, 1983
LIDOCAINE HYDROCHLORIDEPHARMOBEDIENTANDA 087872ATNov 18, 1982
LIDOCAINE HYDROCHLORIDEPHARMOBEDIENTANDA 087881ATNov 18, 1982
LIDOCAINE HYDROCHLORIDE VISCOUSINTL MEDICATIONANDA 086389—Feb 02, 1982
ALPHACAINE HYDROCHLORIDECARLISLEANDA 084721—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×4ABRAXIS PHARMANDA 080420—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2ABRAXIS PHARMANDA 086761—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDEAM REGENTANDA 080850—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDEBEL MARANDA 080710—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDEBEL MARANDA 080760—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDEBELMORA LLCANDA 080504—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDEDELL LABSANDA 083387—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDEDELL LABSANDA 083388—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDEELKINS SINNANDA 085131—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDEELKINS SINNANDA 084626—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2EPIC PHARMA LLCANDA 085037—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×3FRESENIUS KABI USAANDA 088586APApproved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2GD SEARLE LLCANDA 083135—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDERLD×5HOSPIRAANDA 083158—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDERLD×2INTL MEDICATIONANDA 083173APApproved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDELUITPOLDANDA 083198—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2LYPHOMEDANDA 080390—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2MILESANDA 080414—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2WATSON LABSANDA 080377—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2WATSON LABSANDA 083627—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2WEST-WARD PHARMS INTANDA 080407APApproved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE×2WYETH AYERSTANDA 083083—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE×2HIKMAANDA 084625APApproved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE×2HOSPIRAANDA 080408APApproved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%RLDHOSPIRAANDA 083914—Approved Prior to Jan 1, 1982
ANESTACONBIONPHARMAANDA 080429—Approved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDEINTL MEDICATIONANDA 086283ATApproved Prior to Jan 1, 1982
LIDOCAINE HYDROCHLORIDE VISCOUSACTAVIS MID ATLANTICANDA 086578—Approved Prior to Jan 1, 1982
LARYNG-O-JET KITINTL MEDICATIONANDA 086364ATApproved Prior to Jan 1, 1982
LTA II KITHOSPIRAANDA 080409—Approved Prior to Jan 1, 1982
PEDIATRIC LTA KITHOSPIRAANDA 085995—Approved Prior to Jan 1, 1982

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8759401Jul 24, 2026in 1 mo
ProductU-1523
8540665Oct 22, 2029in 3 yr 5 mo
U-1438
9358338Apr 27, 2035in 9 yr
U-1870
9370622Sep 28, 2035in 9 yr 5 mo
U-1870

Lidocaine hydrochloride — frequently asked questions

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

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