TERBINAFINE Drug Patent Profile

When do Terbinafine patents expire, and when can generic versions of Terbinafine launch?

Terbinafine is a drug marketed by 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 sixteen NDAs.

The generic ingredient in TERBINAFINE is terbinafine hydrochloride. There are twenty-seven drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the terbinafine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Terbinafine

A generic version of TERBINAFINE was approved as terbinafine hydrochloride by TARO on July 2^nd, 2007.

Summary for TERBINAFINE

US Patents:	0
Applicants:	15
NDAs:	16
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TERBINAFINE
Drug Sales Revenues:	Drug sales revenues for TERBINAFINE
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
IQVIA Biotech	Phase 3
Moberg Pharma AB	Phase 3

See all TERBINAFINE clinical trials

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
Taro	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	CREAM;TOPICAL	077511-001	Jul 2, 2007		OTC	No	No
Emed Medcl	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077919-001	Jul 2, 2007	AB	RX	No	No
Chartwell	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078199-001	Jul 2, 2007	AB	RX	No	No
Mylan	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077136-001	Jul 2, 2007		DISCN	No	No
Gedeon Richter Usa	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077065-001	Jul 2, 2007		DISCN	No	No
Wockhardt	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078229-001	Jul 2, 2007		DISCN	No	No
Orbion Pharms	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078163-001	Jul 2, 2007	AB	RX	No	No