NORTRIPTYLINE HYDROCHLORIDE Drug Patent Profile

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Nortriptyline Hydrochloride is a drug marketed by Ani Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Rising, Taro, Teva, Zydus Lifesciences, Pharm Assoc, and Rubicon. and is included in eleven NDAs.

The generic ingredient in NORTRIPTYLINE HYDROCHLORIDE is nortriptyline hydrochloride. There are twelve drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the nortriptyline hydrochloride profile page.

A generic version of NORTRIPTYLINE HYDROCHLORIDE was approved as nortriptyline hydrochloride by DR REDDYS LABS SA on March 30^th, 1992.

US Patents:	0
Applicants:	9
NDAs:	11
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	50
Patent Applications:	1,473
DailyMed Link:	NORTRIPTYLINE HYDROCHLORIDE at DailyMed

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

Sponsor	Phase
Chang Gung Memorial Hospital	Phase 2
Assiut University	N/A
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude	Phase 2

Drug Class	Tricyclic Antidepressant

Adrenergic Uptake Inhibitors
Antidepressive Agents, Tricyclic

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

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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
Zydus Lifesciences	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	213441-004	Feb 24, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	074132-004	Mar 27, 1995	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharm Assoc	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	SOLUTION;ORAL	075606-001	Aug 23, 2000	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Lifesciences	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	213441-001	Feb 24, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ani Pharms	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	074054-001	Dec 31, 1992		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	075520-003	May 8, 2000	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	074132-002	Mar 27, 1995	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