SILENOR Drug Patent Profile
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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 fifteen 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. Forty-seven suppliers are listed for this compound. Additional details are available on the doxepin hydrochloride profile page.
DrugPatentWatch® 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: | 15 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 119 |
| Clinical Trials: | 2 |
| Patent Applications: | 1,141 |
| 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 |
| What excipients (inactive ingredients) are in SILENOR? | SILENOR excipients list |
| 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 |
| Currax Pharmaceuticals | Phase 4 |
| Henry Ford Hospital | Phase 4 |
Pharmacology for SILENOR
| Drug Class | Tricyclic Antidepressant |
Anatomical Therapeutic Chemical (ATC) Classes for SILENOR
Paragraph IV (Patent) Challenges for SILENOR
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| SILENOR | Tablets | doxepin hydrochloride | 3 mg and 6 mg | 022036 | 2 | 2010-09-16 |
US Patents and Regulatory Information for SILENOR
SILENOR is protected by fifteen US patents.
Patents protecting SILENOR
Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Low-dose doxepin formulations and methods of making and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Low-dose doxepin formulations and methods of making and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Low-dose doxepin for treatment of sleep disorders in elderly patients
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Low-dose doxepin formulations and methods of making and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of improving the pharmacokinetics of doxepin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Methods of using low-dose doxepin for the improvement of sleep
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF INSOMNIA
Low-dose doxepin formulations and methods of making and using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 | 022036-002 | 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 |
| 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for SILENOR
See the table below for patents covering SILENOR around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | H10500426 | ⤷ Try a Trial | |
| Norway | 963732 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2007142810 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2007142811 | ⤷ Try a Trial | |
| Japan | 2018044006 | 睡眠改善のための低用量ドキセピンの使用法 (METHODS OF USING LOW DOSE DOXEPIN FOR SLEEP IMPROVEMENT) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
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