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Last Updated: April 24, 2024

Doxepin hydrochloride - Generic Drug Details

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What are the generic sources for doxepin hydrochloride and what is the scope of freedom to operate?

Doxepin hydrochloride is the generic ingredient in four branded drugs marketed by Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Chemistry Hlth, Contract Pharmacal, Dava Pharms Inc, Edenbridge Pharms, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Unique Pharm, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pfizer, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Mylan, Actavis Elizabeth, Rk Pharma, Strides Pharma, Zydus Pharms, and Currax, and is included in seventy-nine NDAs. There are fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxepin hydrochloride has sixteen patent family members in four countries.

There is one drug master file entry for doxepin hydrochloride. Forty-nine suppliers are listed for this compound.

Summary for doxepin hydrochloride

International Patents:	16
US Patents:	15
Tradenames:	4
Applicants:	40
NDAs:	79
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	21
Patent Applications:	1,373
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doxepin hydrochloride
What excipients (inactive ingredients) are in doxepin hydrochloride?	doxepin hydrochloride excipients list
DailyMed Link:	doxepin hydrochloride at DailyMed

Recent Clinical Trials for doxepin hydrochloride

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

Sponsor	Phase
E2Bio Life Sciences, LLC	Phase 1/Phase 2
Hematology Center after Prof. R. Yeolyan	Phase 1/Phase 2
State University of New York - Upstate Medical University	Phase 3

See all doxepin hydrochloride clinical trials

Pharmacology for doxepin hydrochloride

Drug Class	Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for doxepin hydrochloride

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Paragraph IV (Patent) Challenges for DOXEPIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SILENOR	Tablets	doxepin hydrochloride	3 mg and 6 mg	022036	2	2010-09-16

US Patents and Regulatory Information for doxepin 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
Epic Pharma Llc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	210675-005	Mar 3, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	072986-001	Mar 29, 1991		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Quantum Pharmics	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	072375-001	Mar 15, 1989		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
New River	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	016987-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Elizabeth	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	TABLET;ORAL	201951-002	Jul 26, 2013	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Unique Pharm	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	217975-003	Aug 21, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-006	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-001	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	⤷ Try a Trial	⤷ Try a Trial
New River	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	016987-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	⤷ Try a Trial	⤷ Try a Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	⤷ Try a Trial	⤷ Try a Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for doxepin hydrochloride

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007142811		⤷ Try a Trial
Japan	2016041757	睡眠改善のための低用量ドキセピンの使用法 (METHODS OF USING LOW DOSE DOXEPIN FOR SLEEP IMPROVEMENT)	⤷ Try a Trial
Canada	2687124	FORMULATIONS DE DOXEPINE A FAIBLE DOSE, INCLUANT DES FORMULATIONS BUCCALES, SUBLINGUALES ET A DISSOLUTION RAPIDE, ET LEURS UTILISATIONS POUR TRAITER L'INSOMNIE (LOW DOSE DOXEPIN FORMULATIONS, INCLUDING BUCCAL, SUBLINGUAL AND FASTMELT FORMULATIONS, AND USES OF THE SAME TO TREAT INSOMNIA)	⤷ Try a Trial
European Patent Office	2148659	FORMULATIONS DE DOXÉPINE À FAIBLE DOSE ET PROCÉDÉ DE PRÉPARATION ET D'UTILISATION DE CELLE-CI (LOW-DOSE DOXEPIN FORMULATIONS)	⤷ Try a Trial
Japan	2009537553		⤷ Try a Trial
Canada	2721133	FORMULATIONS DE DOXEPINE A FAIBLE DOSE ET PROCEDE DE PREPARATION ET D'UTILISATION DE CELLE-CI (LOW-DOSE DOXEPIN FORMULATIONS AND METHODS OF MAKING AND USING THE SAME)	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007142810		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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