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 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 sixteen 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:	16
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
Lannett Co Inc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	212997-004	Jul 24, 2020		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Lannett Co Inc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	212997-001	Jul 24, 2020		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Teva Pharms	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CONCENTRATE;ORAL	071609-001	Nov 9, 1987		DISCN	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Unique Pharm	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	217975-001	Aug 21, 2023	AB	RX	No	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
>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	⤷ Subscribe	⤷ Subscribe
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	⤷ Subscribe	⤷ Subscribe
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	⤷ Subscribe	⤷ Subscribe
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	⤷ Subscribe	⤷ Subscribe
>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		⤷ Subscribe
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)	⤷ Subscribe
Canada	2687124		⤷ Subscribe
World Intellectual Property Organization (WIPO)	2007142810		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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