Doxepin hydrochloride - Generic Drug Details

What are the generic drug 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, 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, Xttrium Labs Inc, 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. Forty-two 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:	42
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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Purepac Pharm	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	072110-001	Sep 8, 1988		DISCN	No	No
Appco	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	214908-004	Apr 1, 2021	AB	RX	No	No
Dava Pharms Inc	DOXEPIN HYDROCHLORIDE	doxepin hydrochloride	CAPSULE;ORAL	071686-001	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	022036-002	Mar 17, 2010
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010
Pfizer	SINEQUAN	doxepin hydrochloride	CAPSULE;ORAL	016798-002	Approved Prior to Jan 1, 1982

International Patents for doxepin hydrochloride

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008128115
Japan	2009537553
European Patent Office	2148659	FORMULATIONS DE DOXÉPINE À FAIBLE DOSE ET PROCÉDÉ DE PRÉPARATION ET D'UTILISATION DE CELLE-CI (LOW-DOSE DOXEPIN FORMULATIONS)