You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 16, 2024

Details for New Drug Application (NDA): 022036

✉ Email this page to a colleague

« Back to Dashboard

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 fifteen 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. Forty-nine 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:	15
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)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 3MG BASE
Approval Date:	Mar 17, 2010	TE:	AB	RLD:	Yes
Patent:	⤷ Try a Trial	Patent Expiration:	May 18, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA
Patent:	⤷ Try a Trial	Patent Expiration:	Apr 11, 2028	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA
Patent:	⤷ Try a Trial	Patent Expiration:	Jul 20, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF INSOMNIA

Expired US Patents for NDA 022036

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	⤷ Try a Trial	⤷ Try a Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	⤷ Try a Trial	⤷ Try a Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	⤷ Try a Trial	⤷ Try a Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-001	Mar 17, 2010	⤷ Try a Trial	⤷ Try a Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	⤷ Try a Trial	⤷ Try a Trial
Currax	SILENOR	doxepin hydrochloride	TABLET;ORAL	022036-002	Mar 17, 2010	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.