PROTRIPTYLINE HYDROCHLORIDE Drug Patent Profile

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Which patents cover Protriptyline Hydrochloride, and what generic alternatives are available?

Protriptyline Hydrochloride is a drug marketed by Epic Pharma Llc, Hikma, and Sigmapharm Labs Llc. and is included in three NDAs.

The generic ingredient in PROTRIPTYLINE HYDROCHLORIDE is protriptyline hydrochloride. There are six drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the protriptyline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Protriptyline Hydrochloride

A generic version of PROTRIPTYLINE HYDROCHLORIDE was approved as protriptyline hydrochloride by HIKMA on September 16^th, 2008.

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Summary for PROTRIPTYLINE HYDROCHLORIDE

US Patents:	0
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	58
Clinical Trials:	2
Patent Applications:	699
DailyMed Link:	PROTRIPTYLINE HYDROCHLORIDE at DailyMed

Drug patent expirations by year for PROTRIPTYLINE HYDROCHLORIDE

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Epic Pharma Llc	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	202220-001	Nov 19, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	078913-002	Sep 16, 2008	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Epic Pharma Llc	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	202220-002	Nov 19, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	078913-001	Sep 16, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sigmapharm Labs Llc	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	090462-002	May 3, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sigmapharm Labs Llc	PROTRIPTYLINE HYDROCHLORIDE	protriptyline hydrochloride	TABLET;ORAL	090462-001	May 3, 2010	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration