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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 Pharms Ltd, Amneal Pharms Co, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Contract Pharmacal, Dava Pharms Inc, Epic Pharma Llc, Lannett Co Inc, Leading Pharma Llc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Taro Pharm Inds Ltd, Watson Labs, Watson Labs Teva, Pfizer, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Mylan, Actavis Elizabeth, Par Pharm Inc, Rk Pharma, and Currax, and is included in sixty-seven NDAs. There are twelve 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 are seven drug master file entries for doxepin hydrochloride. Thirty-one suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for doxepin hydrochloride

International Patents:	16
US Patents:	12
Tradenames:	4
Applicants:	30
NDAs:	67
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	31
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	17
Patent Applications:	1,240
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
Aalborg University	N/A
University of Balamand	Phase 4
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all doxepin hydrochloride clinical trials

Generic filers with tentative approvals for DOXEPIN HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		6MG	TABLET; ORAL
		3MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	NDA	Submissiondate
SILENOR	TABLET;ORAL	doxepin hydrochloride	022036	2010-09-16

US Patents and Regulatory Information for doxepin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CONCENTRATE;ORAL	071609-001	Nov 9, 1987		DISCN	No	No
Amneal Pharms Co	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	207482-005	Jun 28, 2017	AB	RX	No	No
Watson Labs	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	070954-001	May 15, 1986		DISCN	No	No
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Leading Pharma Llc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	211619-001	Mar 9, 2021	AB	RX	No	No
Taro Pharm Inds Ltd	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	213063-003	Jul 1, 2020	AB	RX	No	No
Taro Pharm Inds Ltd	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	213063-005	Jul 1, 2020	AB	RX	No	No

Expired US Patents for doxepin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
New River	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	016987-004	Approved Prior to Jan 1, 1982
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010
Mylan	ZONALON	doxepin hydrochloride	CREAM;TOPICAL	020126-001	Apr 1, 1994
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010
New River	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	016987-001	Approved Prior to Jan 1, 1982

International Patents for doxepin hydrochloride

Country	Patent Number	Estimated Expiration
Canada	2721133
Japan	2016041757
Canada	2687118
Japan	2009537553
World Intellectual Property Organization (WIPO)	2007136845
World Intellectual Property Organization (WIPO)	2008128115
World Intellectual Property Organization (WIPO)	2008011150