TERBINAFINE - Generic Drug Details

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 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-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.

Summary for TERBINAFINE

US Patents:	0
Tradenames:	3
Applicants:	18
NDAs:	24
Drug Master File Entries:	27
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	45
Patent Applications:	7,520
Drug Prices:	Drug price trends for TERBINAFINE
Drug Sales Revenues:	Drug sales revenues for TERBINAFINE
What excipients (inactive ingredients) are in TERBINAFINE?	TERBINAFINE excipients list
DailyMed Link:	TERBINAFINE at DailyMed

See drug prices for TERBINAFINE

See drug sales revenues for TERBINAFINE

Recent Clinical Trials for TERBINAFINE

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

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

See all TERBINAFINE clinical trials

Generic filers with tentative approvals for TERBINAFINE

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.

Anatomical Therapeutic Chemical (ATC) Classes for TERBINAFINE

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	LAMISIL	terbinafine hydrochloride	TABLET;ORAL	020539-001	May 10, 1996		DISCN	Yes	No
Emed Medcl	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077919-001	Jul 2, 2007	AB	RX	No	No
Gedeon Richter Usa	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077065-001	Jul 2, 2007		DISCN	No	No
Novartis	LAMISIL	terbinafine hydrochloride	CREAM;TOPICAL	020192-001	Dec 30, 1992		DISCN	No	No
Dr Reddys Labs Inc	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	076390-001	Jul 2, 2007	AB	RX	No	No
Breckenridge Pharm	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077714-001	Jun 4, 2010	AB	RX	No	No

Expired US Patents for TERBINAFINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998
Karo Hlthcare	LAMISIL	terbinafine	GEL;TOPICAL	020846-001	Apr 29, 1998
Karo Hlthcare	LAMISIL AT	terbinafine	GEL;TOPICAL	021958-001	Jul 24, 2006
Karo Hlthcare	LAMISIL AT	terbinafine	GEL;TOPICAL	021958-001	Jul 24, 2006
Karo Hlthcare	LAMISIL AT	terbinafine	GEL;TOPICAL	021958-001	Jul 24, 2006