Details for New Drug Application (NDA): 022036

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NDA 022036 describes SILENOR, which is a drug marketed by Currax and is included in one NDA. It is available from three suppliers. There are ten patents protecting this drug and one Paragraph IV challenge. Additional details are available on the SILENOR profile page.

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

Summary for 022036

Tradename:	SILENOR
Applicant:	Currax
Ingredient:	doxepin hydrochloride
Patents:	10
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022036

Medical Subject Heading (MeSH) Categories for 022036

Antidepressive Agents, Tricyclic
Histamine Antagonists
Sleep Aids, Pharmaceutical

Suppliers and Packaging for NDA: 022036

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SILENOR	doxepin hydrochloride	TABLET;ORAL	022036	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-4810	0378-4810-93	30 TABLET in 1 BOTTLE, PLASTIC (0378-4810-93)
SILENOR	doxepin hydrochloride	TABLET;ORAL	022036	NDA AUTHORIZED GENERIC	Mylan Pharmaceuticals Inc.	0378-4811	0378-4811-93	30 TABLET in 1 BOTTLE, PLASTIC (0378-4811-93)

Paragraph IV (Patent) Challenges for 022036

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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 3MG BASE
Approval Date:	Mar 17, 2010	TE:		RLD:	Yes
Patent:	Start Trial	Patent Expiration:	May 18, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA
Patent:	Start Trial	Patent Expiration:	Feb 17, 2020	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA
Patent:	Start Trial	Patent Expiration:	Aug 24, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA

Expired US Patents for NDA 022036

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	Start Trial	Start Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	Start Trial	Start Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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