Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

DrugPatentWatch Database Preview

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 one supplier. 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-one 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
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)
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:RXDosage:TABLET;ORALStrengthEQ 3MG BASE
Approval Date:Mar 17, 2010TE:RLD:Yes
Patent:  Start TrialPatent Expiration:May 18, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INSOMNIA
Patent:  Start TrialPatent Expiration:Feb 17, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INSOMNIA
Patent:  Start TrialPatent Expiration:Aug 24, 2027Product 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
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-001 Mar 17, 2010   Start Trial   Start Trial
Currax SILENOR doxepin hydrochloride TABLET;ORAL 022036-002 Mar 17, 2010   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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