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Last Updated: August 8, 2020

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DOXEPIN HYDROCHLORIDE Drug Profile

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Which patents cover Doxepin Hydrochloride, and what generic alternatives are available?

Doxepin Hydrochloride is a drug marketed by Ajanta Pharma Ltd, Amneal Pharms Co, Aurobindo Pharma Ltd, Dava Pharms Inc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Lannett Co Inc, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Actavis Elizabeth, and Mylan. and is included in fifty-three NDAs.

The generic ingredient in DOXEPIN HYDROCHLORIDE is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Doxepin Hydrochloride

A generic version of DOXEPIN HYDROCHLORIDE was approved as doxepin hydrochloride by MYLAN PHARMS INC on May 13th, 1986.

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

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SponsorPhase
Aalborg UniversityN/A
University of BalamandPhase 4
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all DOXEPIN HYDROCHLORIDE clinical trials

Pharmacology for DOXEPIN HYDROCHLORIDE
Medical Subject Heading (MeSH) Categories for DOXEPIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DOXEPIN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
SILENOR TABLET;ORAL doxepin hydrochloride 022036 2010-09-16

US Patents and Regulatory Information for DOXEPIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 071764-001 Feb 9, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 073055-001 Dec 28, 1990 DISCN No No   Start Trial   Start Trial   Start Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-007 Apr 13, 1987 DISCN 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 DOXEPIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-003 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
New River DOXEPIN HYDROCHLORIDE doxepin hydrochloride CAPSULE;ORAL 016987-004 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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