NORTRIPTYLINE HYDROCHLORIDE - Generic Drug Details

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

Nortriptyline hydrochloride is the generic ingredient in four branded drugs marketed by Lilly, Ani Pharms, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Rising, Taro, Teva, Zydus Lifesciences, Specgx Llc, Ranbaxy, Pharm Assoc, and Rubicon, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for nortriptyline hydrochloride. Twenty-eight suppliers are listed for this compound.

Summary for NORTRIPTYLINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	12
NDAs:	15
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	50
Patent Applications:	2,160
What excipients (inactive ingredients) are in NORTRIPTYLINE HYDROCHLORIDE?	NORTRIPTYLINE HYDROCHLORIDE excipients list
DailyMed Link:	NORTRIPTYLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for NORTRIPTYLINE HYDROCHLORIDE

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

See all NORTRIPTYLINE HYDROCHLORIDE clinical trials

Pharmacology for NORTRIPTYLINE HYDROCHLORIDE

Drug Class	Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for NORTRIPTYLINE HYDROCHLORIDE

Adrenergic Uptake Inhibitors
Antidepressive Agents, Tricyclic

Anatomical Therapeutic Chemical (ATC) Classes for NORTRIPTYLINE HYDROCHLORIDE

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

US Patents and Regulatory Information for NORTRIPTYLINE 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
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-004	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	074132-001	Mar 27, 1995	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	SOLUTION;ORAL	217731-001	Aug 15, 2023	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	073556-004	Mar 30, 1992	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	NORTRIPTYLINE HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	073556-001	Mar 30, 1992	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

Expired US Patents for NORTRIPTYLINE HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Specgx Llc	PAMELOR	nortriptyline hydrochloride	SOLUTION;ORAL	018012-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Lilly	AVENTYL HYDROCHLORIDE	nortriptyline hydrochloride	CAPSULE;ORAL	014684-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013-004	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Ranbaxy	AVENTYL	nortriptyline hydrochloride	SOLUTION;ORAL	014685-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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