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Last Updated: September 27, 2020

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LIDOCAINE HYDROCHLORIDE - Generic Drug Details

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

Lidocaine hydrochloride is the generic ingredient in thirty-five branded drugs marketed by Akorn, Carlisle, Abbott, Abraxis Pharm, Am Regent, Aurobindo Pharma Ltd, B Braun Medical Inc, Bel Mar, Belmora Llc, 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, Astrazeneca, Dentsply Pharm, Bionpharma Inc, Sagent Pharms Inc, Cosette, Watson Labs Inc, Oak Pharms, Hi Tech Pharma, Wockhardt Bio Ag, Actavis Mid Atlantic, Lannett Co Inc, Hikma, Kendall Il, Paco, Teligent Pharma Inc, Powder Pharms, and Pfizer, and is included in one hundred and two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Lidocaine hydrochloride has nineteen patent family members in ten countries.

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

Summary for LIDOCAINE HYDROCHLORIDE
Recent Clinical Trials for LIDOCAINE HYDROCHLORIDE

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

SponsorPhase
St. Joseph's Healthcare HamiltonPhase 2
Mayo ClinicPhase 2/Phase 3
Pain Management Institute Bethesda-Washington-MarylandN/A

See all LIDOCAINE HYDROCHLORIDE clinical trials

US Patents and Regulatory Information for LIDOCAINE HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aurobindo Pharma Ltd LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 203040-001 Mar 14, 2013 AP RX No No   Start Trial   Start Trial   Start Trial
Oak Pharms XYLOCAINE lidocaine hydrochloride JELLY;TOPICAL 008816-001 Approved Prior to Jan 1, 1982 AT RX Yes Yes   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride INJECTABLE;INJECTION 080404-002 Approved Prior to Jan 1, 1982 AP RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa XYLOCAINE PRESERVATIVE FREE lidocaine hydrochloride INJECTABLE;INJECTION 016801-002 Approved Prior to Jan 1, 1982 DISCN Yes 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 HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Powder Pharms ZINGO lidocaine hydrochloride SYSTEM;INTRADERMAL 022114-001 Aug 16, 2007   Start Trial   Start Trial
Powder Pharms ZINGO lidocaine hydrochloride SYSTEM;INTRADERMAL 022114-001 Aug 16, 2007   Start Trial   Start Trial
Powder Pharms ZINGO lidocaine hydrochloride SYSTEM;INTRADERMAL 022114-001 Aug 16, 2007   Start Trial   Start Trial
Powder Pharms ZINGO lidocaine hydrochloride SYSTEM;INTRADERMAL 022114-001 Aug 16, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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