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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Boehringer Ingelheim
Argus Health
Johnson and Johnson
Deloitte
Farmers Insurance
Fish and Richardson
Dow
Medtronic

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
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:RXDosage:TABLET;ORALStrengthEQ 3MG BASE
Approval Date:Mar 17, 2010TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Feb 17, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INSOMNIA
Patent:➤ Sign UpPatent Expiration:Aug 24, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INSOMNIA
Patent:➤ Sign UpPatent Expiration:Sep 7, 2030Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INSOMNIA

Expired US Patents for NDA 022036

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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