TERBINAFINE Drug Patent Profile

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

Terbinafine is a drug marketed by Sun Pharma Canada, Aurobindo Pharma, Breckenridge Pharm, Chartwell, Cipla, Emed Medcl, Gedeon Richter Usa, Glenmark Pharms Ltd, Heritage Pharma Avet, Invagen Pharms, Mylan, Natco Pharma, Orbion Pharms, Roxane, Senores Pharms, 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 SUN PHARMA CANADA on July 2^nd, 2007.

Summary for TERBINAFINE

US Patents:	0
Applicants:	16
NDAs:	16
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
Swiss Cancer Institute	PHASE2
Cairo University	NA
Assiut University	NA

See all TERBINAFINE clinical trials

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
Sun Pharma Canada	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	CREAM;TOPICAL	077511-001	Jul 2, 2007		OTC	No	No
Gedeon Richter Usa	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077065-001	Jul 2, 2007		DISCN	No	No
Chartwell	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078199-001	Jul 2, 2007	AB	RX	No	No
Natco Pharma	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	077195-001	Jul 2, 2007		DISCN	No	No
Glenmark Pharms Ltd	TERBINAFINE HYDROCHLORIDE	terbinafine hydrochloride	TABLET;ORAL	078157-001	Jul 2, 2007	AB	RX	No	No