DrugPatentWatch Database Preview
SILENOR Drug Profile
» See Plans and Pricing
Which patents cover Silenor, and when can generic versions of Silenor launch?
Silenor is a drug marketed by Currax and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.
This drug has sixteen patent family members in four countries.
The generic ingredient in SILENOR is doxepin hydrochloride. There are seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
US ANDA Litigation and Generic Entry Outlook for Silenor
A generic version of SILENOR was approved as doxepin hydrochloride by MYLAN PHARMS INC on May 13th, 1986.
Summary for SILENOR
| International Patents: | 16 |
| US Patents: | 13 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 64 |
| Clinical Trials: | 2 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for SILENOR |
| Drug Sales Revenues: | Drug sales revenues for SILENOR |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SILENOR |
| DailyMed Link: | SILENOR at DailyMed |
Recent Clinical Trials for SILENOR
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Balamand | Phase 4 |
| Pernix Theraputics LLC | Phase 4 |
| Henry Ford Hospital | Phase 4 |
Pharmacology for SILENOR
| Drug Class | Tricyclic Antidepressant |
Paragraph IV (Patent) Challenges for SILENOR
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| SILENOR | TABLET;ORAL | doxepin hydrochloride | 022036 | 2010-09-16 |
US Patents and Regulatory Information for SILENOR
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SILENOR
| 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 | 022036-002 | 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 |
International Patents for SILENOR
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2007142811 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2007136845 | Start Trial |
| Norway | 963733 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
