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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, Amneal Pharms Co, Aurobindo Pharma Ltd, Dava Pharms Inc, Mylan Pharms Inc, New River, Par Pharm, Purepac Pharm, Quantum Pharmics, Sandoz, Sun Pharm Industries, Watson Labs, Watson Labs Teva, Pfizer, Lannett Co Inc, Pharm Assoc, Teva Pharms, Wockhardt Bio Ag, Mylan, Actavis Elizabeth, and Currax, and is included in fifty-seven NDAs. There are eleven 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. Twenty-three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for doxepin hydrochloride

International Patents:	16
US Patents:	11
Tradenames:	4
Applicants:	21
NDAs:	57
Drug Master File Entries:	7
Suppliers / Packagers:	23
Bulk Api Vendors:	63
Clinical Trials:	16
Patent Applications:	1,125
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for doxepin hydrochloride
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
		6MG	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
Lannett Co Inc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CONCENTRATE;ORAL	074721-001	Dec 29, 1998	AA	RX	No	Yes
Watson Labs	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071239-001	Apr 30, 1987		DISCN	No	No
Par Pharm	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071422-004	Nov 9, 1987	AB	RX	No	No
Dava Pharms Inc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071675-001	Jan 5, 1988		DISCN	No	No
Dava Pharms Inc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071685-001	Jan 5, 1988		DISCN	No	No

Expired US Patents for doxepin hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-003	Approved Prior to Jan 1, 1982
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010

International Patents for doxepin hydrochloride

Country	Patent Number	Estimated Expiration
Canada	2693992
World Intellectual Property Organization (WIPO)	2007142811
Canada	2687118
Japan	2013237694
European Patent Office	2026792