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SILENOR Drug Profile

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Which patents cover Silenor, and when can generic versions of Silenor launch?

Silenor is a drug marketed by Currax and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in four countries.

The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Silenor

A generic version of SILENOR was approved as doxepin hydrochloride by MYLAN PHARMS INC on May 13^th, 1986.

Summary for SILENOR

International Patents:	16
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	91
Clinical Trials:	2
Patent Applications:	874
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for SILENOR
Drug Sales Revenues:	Drug sales revenues for SILENOR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SILENOR
What excipients (inactive ingredients) are in SILENOR?	SILENOR excipients list
DailyMed Link:	SILENOR at DailyMed

See drug prices for SILENOR

See drug sales revenues for SILENOR

Recent Clinical Trials for SILENOR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Balamand	Phase 4
Pernix Theraputics LLC	Phase 4
Henry Ford Hospital	Phase 4

See all SILENOR clinical trials

Pharmacology for SILENOR

Drug Class

Tricyclic Antidepressant

ATC Classes for SILENOR

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 SILENOR

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

US Patents and Regulatory Information for SILENOR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	AB	RX	Yes	No
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	AB	RX	Yes	Yes
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	AB	RX	Yes	Yes			Y
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	AB	RX	Yes	No
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	AB	RX	Yes	No

Expired US Patents for SILENOR

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	022036-002	Mar 17, 2010
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010

International Patents for SILENOR

Country	Patent Number	Estimated Expiration
Norway	963732
Brazil	9605329
Finland	963497
Australia	4759896
World Intellectual Property Organization (WIPO)	2008128115