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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 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.
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 |
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