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Last Updated: March 29, 2024

Lidocaine - Generic Drug Details


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What are the generic drug sources for lidocaine and what is the scope of patent protection?

Lidocaine is the generic ingredient in forty-five branded drugs marketed by Astrazeneca, Noven, Carlisle, Ailex Pharms Llc, Alembic, Alkem Labs Ltd, Amneal Pharms, Belmora Llc, Cosette, Dr Reddys, Encube, Fougera Pharms Inc, Glenmark Pharms Ltd, Macleods Pharms Ltd, Quagen, Rising, Septodont Inc, Strides Pharma, Taro, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Amneal, Ibsa, Mylan Technologies, Nal Pharm, Noven Pharms Inc, Teikoku Pharma Usa, Scilex Pharms, Thea Pharma, Abbott, Abraxis Pharm, Afaxys, Am Regent, Aspiro, B Braun Medical Inc, Bel Mar, Dell Labs, Elkins Sinn, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Mankind Pharma, Miles, Sintetica Us, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Baxter Hlthcare, B Braun, Mylan Labs Ltd, Pharmaton, Meridian Medcl Techn, Dentsply Pharm, Bionpharma, Sagent Pharms Inc, Sentiss, Watson Labs Inc, Hikma, Rubicon, Wockhardt Bio Ag, Actavis Mid Atlantic, Chartwell Molecular, Kendall Il, Lannett Co Inc, Novitium Pharma, Paco, Pai Holdings Pharm, Powder Pharms, Pfizer, Teva Branded Pharm, Fougera Pharms, Padagis Us, Rhodes Pharms, and Galen Specialty, and is included in one hundred and fifty-eight NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lidocaine has thirty-seven patent family members in eighteen countries.

There are twenty-nine drug master file entries for lidocaine. Forty-five suppliers are listed for this compound.

Drug Prices for lidocaine

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Drug Sales Revenue Trends for lidocaine

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Recent Clinical Trials for lidocaine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Arkansas Children's Hospital Research InstitutePhase 4
Indonesia Endowment Fund for EducationPhase 4
Universitas Sebelas MaretPhase 4

See all lidocaine clinical trials

Pharmacology for lidocaine
Medical Subject Heading (MeSH) Categories for lidocaine
Paragraph IV (Patent) Challenges for LIDOCAINE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ZTLIDO Topical Patch lidocaine 1.80% 207962 1 2022-03-17
LIDODERM Topical Patch lidocaine 5% 020612 1 2009-11-13

US Patents and Regulatory Information for lidocaine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fougera Pharms Inc LIDOCAINE lidocaine OINTMENT;TOPICAL 080198-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Scilex Pharms ZTLIDO lidocaine PATCH;TOPICAL 207962-001 Feb 28, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Fresenius Kabi Usa XYLOCAINE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 016801-001 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Paco LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride SOLUTION;TOPICAL 089688-001 Jun 30, 1989 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Septodont Inc LIDOCAINE lidocaine OINTMENT;TOPICAL 040911-001 May 23, 2011 AT RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca EMLA lidocaine; prilocaine DISC;TOPICAL 020962-001 Feb 4, 1998 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eugia Pharma LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 203040-002 Mar 14, 2013 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for lidocaine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999 ⤷  Try a Trial ⤷  Try a Trial
Noven DENTIPATCH lidocaine FILM, EXTENDED RELEASE;BUCCAL 020575-001 May 21, 1996 ⤷  Try a Trial ⤷  Try a Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999 ⤷  Try a Trial ⤷  Try a Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999 ⤷  Try a Trial ⤷  Try a Trial
Noven DENTIPATCH lidocaine PATCH;TOPICAL 020575-002 May 21, 1996 ⤷  Try a Trial ⤷  Try a Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999 ⤷  Try a Trial ⤷  Try a Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for lidocaine

Country Patent Number Title Estimated Expiration
Croatia P20181230 ⤷  Try a Trial
European Patent Office 2708229 TIMBRE NON AQUEUX (NON-AQUEOUS PATCH) ⤷  Try a Trial
Mexico 2014003688 PARCHE NO ACUOSO. (NON-AQUEOUS PATCH.) ⤷  Try a Trial
Taiwan 201318652 Non-aqueous patch ⤷  Try a Trial
Mexico 2013013121 PARCHE NO ACUOSO. (NON-AQUEOUS PATCH.) ⤷  Try a Trial
Serbia 57451 NE-VODENA OBLOGA (NON-AQUEOUS PATCH) ⤷  Try a Trial
Brazil 112014006719 emplastro não aquoso ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.