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Last Updated: March 28, 2024

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 Haleon Us Holdings, Novartis, Taro, Aurobindo Pharma, Breckenridge Pharm, Chartwell, Cipla, Dr Reddys Labs Inc, Emed Medcl, Gedeon Richter Usa, Glenmark Generics, Heritage Pharma Avet, Invagen Pharms, Mylan, Orbion Pharms, 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

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SponsorPhase
Dhaka Medical CollegePhase 2/Phase 3
Moberg Pharma ABPhase 3
IQVIA BiotechPhase 3

See all terbinafine clinical trials

Generic filers with tentative approvals for TERBINAFINE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a TrialEQ 250MG BASETABLET; ORAL
⤷  Try a Trial⤷  Try a TrialEQ 250MG BASETABLET;ORAL
⤷  Try a Trial⤷  Try a 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
Wockhardt TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078229-001 Jul 2, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heritage Pharma Avet TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076377-001 Jul 2, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077195-001 Jul 2, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071-001 Sep 28, 2007 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Invagen Pharms TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077533-001 Jul 2, 2007 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980-001 Mar 9, 1999 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Haleon Us Holdings LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings LAMISIL AT terbinafine GEL;TOPICAL 021958-001 Jul 24, 2006 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings LAMISIL terbinafine GEL;TOPICAL 020846-001 Apr 29, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.