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Last Updated: April 16, 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
Hematology Center after Prof. R. Yeolyan	Phase 1/Phase 2
E2Bio Life Sciences, LLC	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
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-006	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lannett Co Inc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	212997-003	Jul 24, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Leading	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	211618-001	Mar 1, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	070952-001	Mar 4, 1987		DISCN	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
New River	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	016987-003	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
New River	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	016987-006	Approved Prior to Jan 1, 1982	⤷ Try a Trial	⤷ Try a Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	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
>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
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
Japan	2009537553		⤷ Try a Trial
Japan	2009537554		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.