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FDA Orange Book · active-ingredient family

Lidocaine

Lidocaine is approved as 8 brand and 31 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BONDLIDO · NDA 215029

8

Brand (NDA)

31

Generics (ANDA)

8

Listed patents

1

Exclusivity periods

Brand (NDA) products · aerosol, film, extended release, ointment, patch, solution, suppository, system

ProductApplicantApplicationTEApproved
BONDLIDORLDMEDRX USANDA 215029—Sep 24, 2025
ZTLIDORLDSCILEX PHARMSNDA 207962ABFeb 28, 2018
LIDODERMRLDTEIKOKU PHARMA USANDA 020612ABMar 19, 1999
XYLOCAINERLDASTRAZENECANDA 008048—Approved Prior to Jan 1, 1982
DENTIPATCH×2NOVENNDA 020575—May 21, 1996
XYLOCAINEASTRAZENECANDA 014394—Approved Prior to Jan 1, 1982
XYLOCAINEASTRAZENECANDA 014127—Approved Prior to Jan 1, 1982
XYLOCAINEASTRAZENECANDA 013077—Approved Prior to Jan 1, 1982

Generic (ANDA) products (31)

ProductApplicantApplicationTEApproved
LIDOCAINEUSPHARMAANDA 207059ABFeb 09, 2026
LIDOCAINEALKEM LABS LTDANDA 216484ABOct 06, 2025
LIDOCAINEDIFGEN PHARMSANDA 217221ABMar 25, 2025
LIDOCAINEAUROBINDO PHARMA LTDANDA 217117ATJun 18, 2024
LIDOCAINENAL PHARMANDA 205882ABApr 29, 2021
LIDOCAINEQUAGENANDA 212695ATApr 20, 2021
LIDOCAINECHARTWELL RXANDA 208660ATJan 05, 2021
LIDOCAINENOVEN PHARMS INCANDA 203265—Dec 01, 2020
LIDOCAINEAMNEALANDA 206463ABAug 24, 2020
LIDOCAINEIBSAANDA 209190ABApr 30, 2020
LIDOCAINEMACLEODS PHARMS LTDANDA 211697ATMar 16, 2020
LIDOCAINEGENEYORK PHARMSANDA 212486—Oct 17, 2019
LIDOCAINECOSETTEANDA 211019—Dec 12, 2018
LIDOCAINESTRIDES PHARMAANDA 210958ATDec 11, 2018
LIDOCAINEALEMBICANDA 211469ATNov 23, 2018
LIDOCAINETEVA PHARMS USAANDA 210256—Jan 16, 2018
LIDOCAINEVITRUVIAS THERAPANDA 208822—Sep 25, 2017
LIDOCAINERISINGANDA 208604—Sep 20, 2017
LIDOCAINEALKEM LABS LTDANDA 207810ATMar 10, 2017
LIDOCAINEGLENMARK PHARMS LTDANDA 206498ATSep 09, 2016
LIDOCAINEENCUBEANDA 205318—Feb 01, 2016
LIDOCAINEAMNEAL PHARMSANDA 206297ATAug 07, 2015
LIDOCAINEPHARMOBEDIENTANDA 202346ABAug 07, 2015
LIDOCAINEACTAVIS LABS UT INCANDA 200675ABAug 23, 2012
LIDOCAINESEPTODONT INCANDA 040911ATMay 23, 2011
ALPHACAINECARLISLEANDA 084944—Approved Prior to Jan 1, 1982
ALPHACAINECARLISLEANDA 084946—Approved Prior to Jan 1, 1982
ALPHACAINECARLISLEANDA 084947—Approved Prior to Jan 1, 1982
LIDOCAINEBELMORA LLCANDA 080210—Approved Prior to Jan 1, 1982
LIDOCAINERLDFOUGERA PHARMS INCANDA 080198ATApproved Prior to Jan 1, 1982
LIDOCAINESUN PHARMA CANADAANDA 086724ATApproved Prior to Jan 1, 1982

Marketing exclusivity (1)

  • NPNew product exclusivity (3 years)

    Sep 24, 2028

    in 2 yr 4 mo

Listed patents (8)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9925264May 10, 2031in 5 yr
ProductU-2267
11786455May 10, 2031in 5 yr
ProductU-2267
11793766May 10, 2031in 5 yr
U-2267
9283174May 10, 2031in 5 yr
Product
10765749May 10, 2031in 5 yr
Product
9931403May 10, 2031in 5 yr
Product
11278623May 10, 2031in 5 yr
Product
10765640May 10, 2031in 5 yr
Product

Lidocaine — frequently asked questions

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

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