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Last Updated: June 23, 2024

Lidocaine; prilocaine - Generic Drug Details


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Summary for lidocaine; prilocaine
Recent Clinical Trials for lidocaine; prilocaine

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

SponsorPhase
Indonesia Endowment Fund for EducationPhase 4
Universitas Sebelas MaretPhase 4
Cairo UniversityN/A

See all lidocaine; prilocaine clinical trials

Pharmacology for lidocaine; prilocaine

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
Pai Holdings Pharm LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 205887-001 Jun 29, 2018 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dentsply Pharm ORAQIX lidocaine; prilocaine GEL;PERIODONTAL 021451-001 Dec 19, 2003 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Fougera Pharms LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 076453-001 Aug 18, 2003 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Encube LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 076320-001 Aug 27, 2003 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 076290-001 Sep 25, 2003 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic LIDOCAINE AND PRILOCAINE lidocaine; prilocaine CREAM;TOPICAL 213923-001 Apr 8, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Dentsply Pharm ORAQIX lidocaine; prilocaine GEL;PERIODONTAL 021451-001 Dec 19, 2003 ⤷  Sign Up ⤷  Sign Up
Teva Branded Pharm EMLA lidocaine; prilocaine CREAM;TOPICAL 019941-001 Dec 30, 1992 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for lidocaine; prilocaine

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Recordati Ireland Ltd. Fortacin lidocaine, prilocaine EMEA/H/C/002693
Treatment of primary premature ejaculation in adult men.
Authorised no no no 2013-11-15
Plethora Pharma Solutions Limited Senstend lidocaine, prilocaine EMEA/H/C/005298
Senstend is indicated for the treatment of primary premature ejaculation in adult men.
Withdrawn no no no 2019-11-14
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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