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Last Updated: July 4, 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
Blueberry TherapeuticsPhase 2
IQVIA BiotechPhase 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
Mylan TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077195-001 Jul 2, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Novartis LAMISIL terbinafine hydrochloride TABLET;ORAL 020539-001 May 10, 1996 AB 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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Johnson and Johnson
Baxter
McKinsey
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.