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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 four 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. There are four tentative approvals for this compound. Additional details are available on the doxepin hydrochloride profile page.

Summary for NDA: 022036

Tradename:
SILENOR
Applicant:
Pernix Theraps Llc
Ingredient:
doxepin hydrochloride
Patents:4
Therapeutic Class:Antidepressants
Anxiolytics
Dermatological Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 022036

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 42847-103-03 30 TABLET in 1 BLISTER PACK (42847-103-03)
SILENOR
doxepin hydrochloride
TABLET;ORAL 022036 NDA Pernix Therapeutics, LLC 42847-103 42847-103-10 100 TABLET in 1 BOTTLE (42847-103-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 3MG BASE
Approval Date:Mar 17, 2010TE:ABRLD:No
Patent:6,211,229Patent Expiration:Feb 17, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INSOMNIA
Patent:7,915,307Patent Expiration:Aug 24, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INSOMNIA
Patent:8,513,299Patent Expiration:Sep 7, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INSOMNIA

Expired Orange Book 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;ORAL022036-002Mar 17, 20105,725,884► subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-001Mar 17, 20106,217,909► subscribe
Pernix Theraps Llc
SILENOR
doxepin hydrochloride
TABLET;ORAL022036-002Mar 17, 20105,502,047► subscribe
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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.

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