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Last Updated: September 27, 2020

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PROTRIPTYLINE HYDROCHLORIDE Drug Profile

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US ANDA Litigation and Generic Entry Outlook for Protriptyline Hydrochloride

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

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Drug patent expirations by year for PROTRIPTYLINE HYDROCHLORIDE
Recent Clinical Trials for PROTRIPTYLINE HYDROCHLORIDE

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

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Pharmacology for PROTRIPTYLINE HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories 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
Epic Pharma Llc PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 202220-001 Nov 19, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 078913-002 Sep 16, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Epic Pharma Llc PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 202220-002 Nov 19, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 078913-001 Sep 16, 2008 AB RX No No   Start Trial   Start Trial   Start Trial
Sigmapharm Labs Llc PROTRIPTYLINE HYDROCHLORIDE protriptyline hydrochloride TABLET;ORAL 090462-002 May 3, 2010 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

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