Doxepin hydrochloride - Generic Drug Details

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What are the generic drug 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 Adaptis, Aiping Pharm Inc, Ajanta Pharma Ltd, Alembic, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Dava Pharms Inc, Endo Operations, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, Micro Labs, MSN, Mylan Pharms Inc, New River, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro, Unique Pharm, Velzen Pharma Pvt, Watson Labs, Watson Labs Teva, Zydus Lifesciences, Pfizer, Pharm Assoc, Pharmobedient Cnsltg, Teva Pharms, Amneal, Mylan, Actavis Elizabeth, Rk Pharma, Strides Pharma, and Currax, and is included in eighty-one 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. Fifty suppliers are listed for this compound.

Summary for doxepin hydrochloride

International Patents:	16
US Patents:	15
Tradenames:	4
Applicants:	39
NDAs:	81
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	156
Clinical Trials:	22
Patent Applications:	1,361
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
Nanfang Hospital, Southern Medical University	N/A
E2Bio Life Sciences, LLC	Phase 1/Phase 2
Hematology Center after Prof. R. Yeolyan	Phase 1/Phase 2

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

Anatomical Therapeutic Chemical (ATC) Classes for doxepin hydrochloride

D04AX	Other antipruritics
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

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
Watson Labs	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071485-001	Apr 30, 1987		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Pharm Assoc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CONCENTRATE;ORAL	075924-001	Jan 15, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ajanta Pharma Ltd	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	212624-004	Sep 13, 2019	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

Expired US Patents for doxepin hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	⤷ Sign Up	⤷ Sign Up
Mylan	ZONALON	doxepin hydrochloride	CREAM;TOPICAL	020126-001	Apr 1, 1994	⤷ Sign Up	⤷ Sign Up
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	⤷ Sign Up	⤷ Sign Up
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	⤷ Sign Up	⤷ Sign Up
Pfizer	SINEQUAN	doxepin hydrochloride	CONCENTRATE;ORAL	017516-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
New River	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	016987-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>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)	2007136845		⤷ Sign Up
Japan	2013237694	METHOD OF USING LOW-DOSE DOXEPIN FOR IMPROVEMENT OF SLEEP	⤷ Sign Up
Japan	2018044006	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)	⤷ Sign Up
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)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008011150		⤷ Sign Up
European Patent Office	2026792	FORMULATIONS DE DOXÉPINE À FAIBLE DOSE, INCLUANT DES FORMULATIONS BUCCALES, SUBLINGUALES ET À 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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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