You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 29, 2024

Terbinafine hydrochloride - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug sources for terbinafine hydrochloride and what is the scope of freedom to operate?

Terbinafine hydrochloride 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-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-five drug master file entries for terbinafine hydrochloride. Forty-two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for terbinafine hydrochloride
Recent Clinical Trials for terbinafine hydrochloride

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

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

See all terbinafine hydrochloride clinical trials

Generic filers with tentative approvals for TERBINAFINE HYDROCHLORIDE
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.

Pharmacology for terbinafine hydrochloride

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 ⤷  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
Breckenridge Pharm TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077714-001 Jun 4, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis LAMISIL terbinafine hydrochloride TABLET;ORAL 020539-001 May 10, 1996 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Wockhardt TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078229-001 Jul 2, 2007 DISCN 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
Emed Medcl TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077919-001 Jul 2, 2007 AB RX No No ⤷  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 hydrochloride

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

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.