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Last Updated: December 5, 2019

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Lidocaine; prilocaine - Generic Drug Details

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

Lidocaine; prilocaine is the generic ingredient in three branded drugs marketed by Teva Branded Pharm, Fougera Pharms, Hi Tech Pharma, Teligent Pharma Inc, Tolmar, Astrazeneca, and Dentsply Pharm, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-nine drug master file entries for lidocaine; prilocaine. Seventeen suppliers are listed for this compound.

Recent Clinical Trials for lidocaine; prilocaine

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SponsorPhase
Stanford UniversityPhase 3
Aalborg UniversityN/A
Aga Khan UniversityN/A

See all lidocaine; prilocaine clinical trials

Recent Litigation for lidocaine; prilocaine

Identify potential future generic entrants

District Court Litigation
Case NameDate
Reckitt Benckiser Pharmaceuticals Inc. v. Watson Laboratories Inc.2013-10-08

See all lidocaine; prilocaine litigation

Pharmacology for lidocaine; prilocaine
Synonyms for lidocaine; prilocaine
101362-25-8
C14H22N2O.C13H20N2O
Lidocaine - prilocaine mixt.
Lidocaine and prilocaine
Lidocaine mixture with Prilocaine
Lidocaine prilocaine spray
Lidocaine-prilocaine mixt.
Lidocaine/prilocaine
LS-178543
Medicaina
Propanamide, N-(2-methylphenyl)-2-(propylamino)-, mixt. with 2-(diethylamino)-N-(2,6-dimethylphenyl)acetamide
PSD 502
PSD502
SCHEMBL2019133

US Patents and Regulatory Information for lidocaine; prilocaine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca EMLA lidocaine; prilocaine DISC;TOPICAL 020962-001 Feb 4, 1998 DISCN No 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
Fougera Pharms LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 076453-001 Aug 18, 2003 AB RX No No   Start Trial   Start Trial   Start Trial
Dentsply Pharm ORAQIX lidocaine; prilocaine GEL;PERIODONTAL 021451-001 Dec 19, 2003 RX Yes Yes   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; prilocaine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Teva Branded Pharm EMLA lidocaine; prilocaine CREAM;TOPICAL 019941-001 Dec 30, 1992   Start Trial   Start Trial
Dentsply Pharm ORAQIX lidocaine; prilocaine GEL;PERIODONTAL 021451-001 Dec 19, 2003   Start Trial   Start Trial
Teva Branded Pharm EMLA lidocaine; prilocaine CREAM;TOPICAL 019941-001 Dec 30, 1992   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Johnson and Johnson
McKesson
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Merck

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