Doxepin hydrochloride - Generic Drug Details

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, Edenbridge Pharms, Epic Pharma Llc, Jubilant Cadista, Lannett Co Inc, Leading, Mankind Pharma, MSN, 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, Rk Pharma, Strides Pharma, and Currax, and is included in seventy-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. Thirty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for doxepin hydrochloride

International Patents:	16
US Patents:	15
Tradenames:	4
Applicants:	34
NDAs:	71
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	21
Patent Applications:	1,356
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
E2Bio Life Sciences, LLC	Phase 1/Phase 2
Hematology Center after Prof. R. Yeolyan	Phase 1/Phase 2
State University of New York - Upstate Medical University	Phase 3

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	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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	210268-002	Sep 4, 2020		DISCN	No	No
Mylan	ZONALON	doxepin hydrochloride	CREAM;TOPICAL	020126-001	Apr 1, 1994		RX	Yes	Yes
Leading	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	211619-001	Mar 9, 2021	AB	RX	No	No
Quantum Pharmics	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	070932-001	Sep 29, 1987		DISCN	No	No
Watson Labs	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	070952-001	Mar 4, 1987		DISCN	No	No
Sandoz	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071562-001	Mar 2, 1987		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
Pfizer	SINEQUAN	doxepin hydrochloride	CONCENTRATE;ORAL	017516-001	Approved Prior to Jan 1, 1982
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-005	Approved Prior to Jan 1, 1982
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	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	Title	Estimated Expiration
Japan	2013237694	METHOD OF USING LOW-DOSE DOXEPIN FOR IMPROVEMENT OF SLEEP
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)
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)
Japan	2009537553
World Intellectual Property Organization (WIPO)	2008011150
World Intellectual Property Organization (WIPO)	2008128115