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Generated: August 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022036

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NDA 022036 describes SILENOR, which is a drug marketed by Pernix Theraps Llc and is included in one NDA. It is available from one supplier. There are nine 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-eight suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for 022036

Tradename:	SILENOR
Applicant:	Pernix Theraps Llc
Ingredient:	doxepin hydrochloride
Patents:	9
Therapeutic Class:	Antidepressants Anxiolytics Dermatological Agents
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	Pernix Therapeutics, LLC	42847-103	N	42847-103-03
SILENOR	doxepin hydrochloride	TABLET;ORAL	022036	NDA	Pernix Therapeutics, LLC	42847-103	N	42847-103-10

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:	➤ Sign Up	Patent Expiration:	Feb 17, 2020	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA
Patent:	➤ Sign Up	Patent Expiration:	Aug 24, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA
Patent:	➤ Sign Up	Patent Expiration:	Sep 7, 2030	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
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	➤ Sign Up	➤ Sign Up
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	➤ Sign Up	➤ Sign Up
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	➤ Sign Up	➤ Sign Up
Pernix Theraps Llc	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	➤ Sign Up	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.