PROTRIPTYLINE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for protriptyline hydrochloride and what is the scope of freedom to operate?

Protriptyline hydrochloride is the generic ingredient in two branded drugs marketed by Epic Pharma Llc, Hikma, Sigmapharm Labs Llc, Chartwell Rx, and Teva Womens, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for protriptyline hydrochloride. Three suppliers are listed for this compound.

Summary for PROTRIPTYLINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	2
Patent Applications:	1,069
What excipients (inactive ingredients) are in PROTRIPTYLINE HYDROCHLORIDE?	PROTRIPTYLINE HYDROCHLORIDE excipients list
DailyMed Link:	PROTRIPTYLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for PROTRIPTYLINE HYDROCHLORIDE

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Roxane Laboratories	N/A

See all PROTRIPTYLINE HYDROCHLORIDE clinical trials

Pharmacology for PROTRIPTYLINE HYDROCHLORIDE

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for PROTRIPTYLINE HYDROCHLORIDE

Adrenergic Uptake Inhibitors

Antidepressive Agents, Tricyclic

Anatomical Therapeutic Chemical (ATC) Classes for PROTRIPTYLINE HYDROCHLORIDE

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

US Patents and Regulatory Information for PROTRIPTYLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	078913-002	Sep 16, 2008	AB	RX	No	Yes
Teva Womens	VIVACTIL	protriptyline hydrochloride	TABLET;ORAL	016012-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sigmapharm Labs Llc	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	090462-002	May 3, 2010	AB	RX	No	No
Epic Pharma Llc	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	202220-002	Nov 19, 2012	AB	RX	No	No
Teva Womens	VIVACTIL	protriptyline hydrochloride	TABLET;ORAL	016012-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Hikma	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	078913-001	Sep 16, 2008	AB	RX	No	No
Epic Pharma Llc	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	202220-001	Nov 19, 2012	AB	RX	No	No