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Last Updated: August 9, 2020

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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 Inc, Aurolife Pharma Llc, Mayne Pharma, Mylan, Taro, Teva, Specgx Llc, Ranbaxy, and Pharm Assoc, and is included in thirteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Recent Clinical Trials for nortriptyline hydrochloride

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

SponsorPhase
Lancaster General HospitalPhase 4
University of California, IrvinePhase 4
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2

See all nortriptyline hydrochloride clinical trials

Pharmacology for nortriptyline hydrochloride
Medical Subject Heading (MeSH) Categories for nortriptyline hydrochloride
Paragraph IV (Patent) Challenges for NORTRIPTYLINE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
PAMELOR CAPSULE;ORAL nortriptyline hydrochloride 018013

US Patents and Regulatory Information for nortriptyline hydrochloride

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 018013-001 Approved Prior to Jan 1, 1982 AB RX Yes No   Start Trial   Start Trial   Start Trial
Lilly AVENTYL HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 014684-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 074054-002 Dec 31, 1992 DISCN No No   Start Trial   Start Trial   Start Trial
Taro NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 075520-001 May 8, 2000 AB RX No No   Start Trial   Start Trial   Start Trial
Teva NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 073667-003 Apr 11, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Teva NORTRIPTYLINE HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 074132-003 Mar 27, 1995 AB RX No No   Start Trial   Start Trial   Start Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Lilly AVENTYL HYDROCHLORIDE nortriptyline hydrochloride CAPSULE;ORAL 014684-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Specgx Llc PAMELOR nortriptyline hydrochloride CAPSULE;ORAL 018013-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Ranbaxy AVENTYL nortriptyline hydrochloride SOLUTION;ORAL 014685-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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