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Last Updated: November 2, 2024

PROTRIPTYLINE HYDROCHLORIDE - Generic Drug Details


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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

SponsorPhase
Federal University of São PauloPhase 4
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Roxane LaboratoriesN/A

See all PROTRIPTYLINE HYDROCHLORIDE clinical trials

Pharmacology for PROTRIPTYLINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for PROTRIPTYLINE HYDROCHLORIDE
Anatomical Therapeutic Chemical (ATC) Classes for PROTRIPTYLINE HYDROCHLORIDE

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
Teva Womens VIVACTIL protriptyline hydrochloride TABLET;ORAL 016012-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Rx VIVACTIL protriptyline hydrochloride TABLET;ORAL 073645-001 Aug 24, 1995 DISCN No No ⤷  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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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