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Last Updated: November 22, 2024

TERBINAFINE HYDROCHLORIDE - Generic Drug Details


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

Terbinafine hydrochloride is the generic ingredient in three branded drugs marketed by Karo Hlthcare, Novartis, Taro, Aurobindo Pharma, Breckenridge Pharm, Chartwell, Cipla, Dr Reddys Labs Inc, Emed Medcl, Gedeon Richter Usa, Glenmark Pharms Ltd, Heritage Pharma Avet, Invagen Pharms, Mylan, Natco Pharma, 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-five suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for TERBINAFINE HYDROCHLORIDE
US Patents:0
Tradenames:3
Applicants:18
NDAs:22
Drug Master File Entries: 25
Finished Product Suppliers / Packagers: 45
Raw Ingredient (Bulk) Api Vendors: 115
Clinical Trials: 45
Patent Applications: 2,563
What excipients (inactive ingredients) are in TERBINAFINE HYDROCHLORIDE?TERBINAFINE HYDROCHLORIDE excipients list
DailyMed Link:TERBINAFINE HYDROCHLORIDE at DailyMed
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
⤷  Sign Up⤷  Sign UpEQ 250MG BASETABLET; ORAL
⤷  Sign Up⤷  Sign UpEQ 250MG BASETABLET;ORAL
⤷  Sign Up⤷  Sign UpEQ 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
Breckenridge Pharm TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077714-001 Jun 4, 2010 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Glenmark Pharms Ltd TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 078157-001 Jul 2, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Heritage Pharma Avet TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 076377-001 Jul 2, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis LAMISIL terbinafine hydrochloride GRANULE;ORAL 022071-001 Sep 28, 2007 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gedeon Richter Usa TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077065-001 Jul 2, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cipla TERBINAFINE HYDROCHLORIDE terbinafine hydrochloride TABLET;ORAL 077137-001 Jul 2, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis LAMISIL terbinafine hydrochloride TABLET;ORAL 020539-001 May 10, 1996 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Karo Hlthcare LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 ⤷  Sign Up ⤷  Sign Up
Karo Hlthcare LAMISIL AT terbinafine hydrochloride SPRAY;TOPICAL 021124-002 Mar 17, 2000 ⤷  Sign Up ⤷  Sign Up
Karo Hlthcare LAMISIL terbinafine hydrochloride CREAM;TOPICAL 020980-001 Mar 9, 1999 ⤷  Sign Up ⤷  Sign Up
Karo Hlthcare LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997 ⤷  Sign Up ⤷  Sign Up
Karo Hlthcare LAMISIL terbinafine hydrochloride SOLUTION;TOPICAL 020749-001 Oct 17, 1997 ⤷  Sign Up ⤷  Sign Up
Karo Hlthcare LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 ⤷  Sign Up ⤷  Sign Up
Karo Hlthcare LAMISIL AT terbinafine hydrochloride SOLUTION;TOPICAL 021124-001 Mar 17, 2000 ⤷  Sign Up ⤷  Sign Up
>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.