DOXEPIN HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for doxepin hydrochloride and what is the scope of patent protection?

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
Hematology Center after Prof. R. Yeolyan	Phase 1/Phase 2
E2Bio Life Sciences, LLC	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
Mylan Pharms Inc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	070791-002	May 13, 1986	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Pharms Inc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	070791-005	May 13, 1986	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Micro Labs	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	217688-004	Jun 27, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Quantum Pharmics	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	072375-001	Mar 15, 1989		DISCN	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
>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)	2007142810		⤷ Sign Up
Japan	2016041757		⤷ Sign Up
Japan	2013237694		⤷ Sign Up
European Patent Office	2148659	FORMULATIONS DE DOXÉPINE À FAIBLE DOSE ET PROCÉDÉ DE PRÉPARATION ET D'UTILISATION DE CELLE-CI (LOW-DOSE DOXEPIN FORMULATIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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