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Last Updated: August 3, 2020

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Terbinafine - Generic Drug Details

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

Terbinafine is the generic ingredient in three branded drugs marketed by Glaxosmithkline Cons, Glaxosmithkline, Novartis, Taro, Aurobindo Pharma, Breckenridge Pharm, Chartwell, Cipla, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Heritage Pharma, Invagen Pharms, Mylan, Orchid Hlthcare, Roxane, and Wockhardt, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for terbinafine. There are four tentative approvals for this compound.

Drug Prices for terbinafine

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Drug Sales Revenue Trends for terbinafine

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Recent Clinical Trials for terbinafine

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

SponsorPhase
IQVIA BiotechPhase 2
Blueberry TherapeuticsPhase 2
United LaboratoriesPhase 2

See all terbinafine clinical trials

Generic filers with tentative approvals for TERBINAFINE
Applicant Application No. Strength Dosage Form
  Start Trial  Start TrialEQ 250MG BASETABLET; ORAL
  Start Trial  Start TrialEQ 250MG BASETABLET;ORAL
  Start Trial  Start TrialEQ 250MG BASETABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

US Patents and Regulatory Information for terbinafine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Inc TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076390-001 Jul 2, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077195-001 Jul 2, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharma TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076377-001 Jul 2, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Chartwell TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078199-001 Jul 2, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Roxane TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077223-001 Jul 2, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Glenmark Generics TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078157-001 Jul 2, 2007 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 terbinafine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006   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:

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