AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE - Generic Drug Details

What are the generic drug sources for amitriptyline hydrochloride; perphenazine and what is the scope of patent protection?

Amitriptyline hydrochloride; perphenazine is the generic ingredient in ten branded drugs marketed by Schering, Chartwell Rx, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Par Pharm, Sun Pharm Industries, Watson Labs, and New River, and is included in thirty-seven NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

US Patents:	0
Tradenames:	10
Applicants:	9
NDAs:	37
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	1
Patent Applications:	58
DailyMed Link:	AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE at DailyMed

Recent Clinical Trials for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

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

Sponsor	Phase
Institute of Experimental and Clinical Therapeutics	Phase 2
Hospital Civil de Guadalajara	Phase 2
University of Guadalajara	Phase 2

See all AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE clinical trials

Pharmacology for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Drug Class

Phenothiazine Tricyclic Antidepressant

Anatomical Therapeutic Chemical (ATC) Classes for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

N05AB	Phenothiazines with piperazine structure
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	070373-001	Aug 25, 1986		DISCN	No	No
Fosun Pharma	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	071863-001	Dec 21, 1987		DISCN	No	No
Mylan	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	071443-001	Nov 10, 1988		RX	No	Yes
Watson Labs	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	072134-001	Feb 15, 1989		DISCN	No	No
Fosun Pharma	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	071064-001	Nov 27, 1987		DISCN	No	No
Ivax Sub Teva Pharms	PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	070937-001	Sep 11, 1986		DISCN	No	No

Expired US Patents for AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Schering	ETRAFON 2-10	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014713-007	Approved Prior to Jan 1, 1982
Schering	ETRAFON-FORTE	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014713-006	Approved Prior to Jan 1, 1982
New River	TRIAVIL 2-25	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014715-002	Approved Prior to Jan 1, 1982
New River	TRIAVIL 4-50	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014715-006	Approved Prior to Jan 1, 1982
New River	TRIAVIL 4-25	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014715-005	Approved Prior to Jan 1, 1982
New River	TRIAVIL 4-10	amitriptyline hydrochloride; perphenazine	TABLET;ORAL	014715-003	Approved Prior to Jan 1, 1982