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Last Updated: August 12, 2020

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LIDOCAINE - Generic Drug Details

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What are the generic sources for lidocaine and what is the scope of freedom to operate?

Lidocaine is the generic ingredient in forty-five branded drugs marketed by Astrazeneca, Noven, Carlisle, Aleor Dermaceuticals, Alkem Labs Ltd, Amneal Pharms, Belmora Llc, Cosette, Fougera Pharms Inc, Glenmark Pharms Ltd, Macleods Pharms Ltd, Novast Labs, Septodont Inc, Strides Pharma, Sungen Pharma, Taro, Teligent Pharma Inc, Teva Pharms Usa, Vitruvias Therap, Actavis Labs Ut Inc, Mylan Technologies, Rhodes Pharms, Teikoku Pharma Usa, Scilex Pharms Inc, Akorn, Abbott, Abraxis Pharm, Am Regent, Aurobindo Pharma Ltd, B Braun Medical Inc, Bel Mar, Dell Labs, Elkins Sinn, Fresenius Kabi Usa, Gd Searle Llc, Hospira, Huons, Intl Medication, Luitpold, Lyphomed, Miles, Mylan Labs Ltd, Spectra Mdcl Devices, Watson Labs, West-ward Pharms Int, Wyeth Ayerst, Baxter Hlthcare, B Braun, Pharmaton, Meridian Medcl Techn, Dentsply Pharm, Bionpharma Inc, Sagent Pharms Inc, Watson Labs Inc, Oak Pharms, Hi Tech Pharma, Wockhardt Bio Ag, Actavis Mid Atlantic, Lannett Co Inc, Hikma, Kendall Il, Paco, Powder Pharms, Pfizer, Teva Branded Pharm, Fougera Pharms, Tolmar, Taro Pharms, and Galen Specialty, and is included in one hundred and forty NDAs. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lidocaine has thirteen patent family members in eight countries.

There are twenty-nine drug master file entries for lidocaine. Forty-one 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

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SponsorPhase
St. Joseph's Healthcare HamiltonPhase 2
Washington D.C. Veterans Affairs Medical CenterN/A
Pain Management Institute Bethesda-Washington-MarylandN/A

See all LIDOCAINE clinical trials

Pharmacology for LIDOCAINE
Medical Subject Heading (MeSH) Categories for LIDOCAINE
Paragraph IV (Patent) Challenges for LIDOCAINE
Tradename Dosage Ingredient NDA Submissiondate
LIDODERM PATCH;TOPICAL lidocaine 020612 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
Bionpharma Inc ANESTACON lidocaine hydrochloride JELLY;TOPICAL 080429-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma LIDOCAINE VISCOUS lidocaine hydrochloride SOLUTION;ORAL 088802-001 Apr 26, 1985 AT RX No No   Start Trial   Start Trial   Start Trial
Astrazeneca XYLOCAINE lidocaine OINTMENT;TOPICAL 008048-001 Approved Prior to Jan 1, 1982 DISCN Yes No   Start Trial   Start Trial   Start Trial
Teligent Pharma Inc LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 205887-001 Jun 29, 2018 AB RX No No   Start Trial   Start Trial   Start 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
Noven DENTIPATCH lidocaine PATCH;TOPICAL 020575-002 May 21, 1996   Start Trial   Start Trial
Noven DENTIPATCH lidocaine FILM, EXTENDED RELEASE;BUCCAL 020575-001 May 21, 1996   Start Trial   Start Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999   Start Trial   Start Trial
Teikoku Pharma Usa LIDODERM lidocaine PATCH;TOPICAL 020612-001 Mar 19, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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