DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 022036
Join the DrugPatentWatch Referral Program Get access to a free drug patent landscape report or a free one-month subscription
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 |
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: | RX | Dosage: | TABLET;ORAL | Strength | EQ 3MG BASE | ||||
Approval Date: | Mar 17, 2010 | TE: | RLD: | Yes | |||||
Patent: | Start Trial | Patent Expiration: | May 18, 2027 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF INSOMNIA | ||||||||
Patent: | Start Trial | Patent Expiration: | Feb 17, 2020 | Product Flag? | Substance Flag? | Delist Request? | |||
Patented Use: | TREATMENT OF INSOMNIA | ||||||||
Patent: | Start Trial | Patent Expiration: | Aug 24, 2027 | Product 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 |
Complete Access Available with Subscription