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Last Updated: July 6, 2020

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Terbinafine hydrochloride - Generic Drug Details

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

Terbinafine hydrochloride is the generic ingredient in three branded drugs marketed by Glaxosmithkline, Novartis, Taro, Glaxosmithkline Cons, 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-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for terbinafine hydrochloride. Thirty-six suppliers are listed for this compound. There are four tentative approvals for this compound.

Recent Clinical Trials for terbinafine hydrochloride

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

SponsorPhase
IQVIA BiotechPhase 2
Blueberry TherapeuticsPhase 2
United LaboratoriesPhase 2

See all terbinafine hydrochloride clinical trials

Generic filers with tentative approvals for TERBINAFINE HYDROCHLORIDE
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.

Pharmacology for terbinafine hydrochloride
Paragraph IV (Patent) Challenges for TERBINAFINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
LAMISIL TABLET;ORAL terbinafine hydrochloride 020539

US Patents and Regulatory Information for terbinafine hydrochloride

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
Novartis LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071-001 Sep 28, 2007 DISCN Yes No   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 OTC Yes Yes   Start Trial   Start Trial   Start Trial
Gedeon Richter Usa TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077065-001 Jul 2, 2007 DISCN No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078297-001 Jul 2, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Breckenridge Pharm TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077714-001 Jun 4, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Novartis LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071-002 Sep 28, 2007 DISCN Yes 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 hydrochloride

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Serving leading biopharmaceutical companies globally:

Dow
Express Scripts
McKesson
Merck
Boehringer Ingelheim
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.