Terbinafine hydrochloride - Generic Drug Details

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 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

Sponsor	Phase
Dhaka Medical College	Phase 2/Phase 3
IQVIA Biotech	Phase 3
Moberg Pharma AB	Phase 3

See all terbinafine hydrochloride clinical trials

Generic filers with tentative approvals for TERBINAFINE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 250MG BASE	TABLET; ORAL
		EQ 250MG BASE	TABLET;ORAL
		EQ 250MG BASE	TABLET;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

Drug Class

Allylamine Antifungal

Anatomical Therapeutic Chemical (ATC) Classes for terbinafine hydrochloride

D01AE	Other antifungals for topical use
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

D01BA	Antifungals for systemic use
D01B	ANTIFUNGALS FOR SYSTEMIC USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

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
Aurobindo Pharma	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078297-001	Jul 2, 2007	AB	RX	No	Yes
Novartis	LAMISIL	terbinafine hydrochloride	TABLET;ORAL	020539-001	May 10, 1996		DISCN	Yes	No
Karo Hlthcare	LAMISIL	terbinafine hydrochloride	SOLUTION;TOPICAL	020749-001	Oct 17, 1997		DISCN	No	No
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000		OTC	Yes	Yes
Novartis	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020192-001	Dec 30, 1992		DISCN	No	No
Invagen Pharms	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077533-001	Jul 2, 2007	AB	RX	No	No
Orbion Pharms	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078163-001	Jul 2, 2007	AB	RX	No	No

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
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SPRAY;TOPICAL	021124-002	Mar 17, 2000
Karo Hlthcare	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020980-001	Mar 9, 1999
Karo Hlthcare	LAMISIL	terbinafine hydrochloride	SOLUTION;TOPICAL	020749-001	Oct 17, 1997
Karo Hlthcare	LAMISIL	terbinafine hydrochloride	SOLUTION;TOPICAL	020749-001	Oct 17, 1997
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000
Karo Hlthcare	LAMISIL AT	terbinafine hydrochloride	SOLUTION;TOPICAL	021124-001	Mar 17, 2000