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 sixteen 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-eight 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.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SILENOR?
- What are the global sales for SILENOR?
- What is Average Wholesale Price for SILENOR?
Summary for SILENOR
International Patents: | 16 |
US Patents: | 16 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 119 |
Clinical Trials: | 2 |
Patent Applications: | 1,146 |
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 |
![SILENOR drug patent expirations Drug patent expirations by year for SILENOR](/p/graph/s/t/SILENOR-patent-expirations.png)
![Drug Prices for SILENOR](/p/graph/drug-price/SILENOR.png)
![Drug Sales Revenue Trends for SILENOR](/p/graph/drug-sales-revenues/SILENOR.png)
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 |
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 sixteen US patents.
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 | 9,861,607 | ⤷ Try for Free | ⤷ Try for Free | |||
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | 9,532,971 | ⤷ Try for Free | Y | ⤷ Try for Free | ||
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | 11,110,074 | ⤷ Try for Free | ⤷ Try for Free | |||
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | 11,096,920 | ⤷ Try for Free | ⤷ Try for Free | |||
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | 9,486,437 | ⤷ Try for Free | ⤷ Try for Free | |||
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | AB | RX | Yes | Yes | 9,861,607 | ⤷ Try for Free | ⤷ Try for Free | |||
>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 | 5,866,166 | ⤷ Try for Free |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | 5,866,166 | ⤷ Try for Free |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | 5,502,047 | ⤷ Try for Free |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | 5,502,047 | ⤷ Try for Free |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-002 | Mar 17, 2010 | 5,948,438 | ⤷ Try for Free |
Currax | SILENOR | doxepin hydrochloride | TABLET;ORAL | 022036-001 | Mar 17, 2010 | 6,217,909 | ⤷ Try for Free |
>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 |
---|---|---|---|
Brazil | 9605329 | composiÇço de excipiente, composiÇço em forma de dosagem sàlida, pasta aquosa para preparar excipiente farmacÊutico compressÍvel e processo para obter composiÇço em forma de dosagem sàlida. | ⤷ Try for Free |
Canada | 2721133 | FORMULATIONS DE DOXEPINE A FAIBLE DOSE ET PROCEDE DE PREPARATION ET D'UTILISATION DE CELLE-CI (LOW-DOSE DOXEPIN FORMULATIONS AND METHODS OF MAKING AND USING THE SAME) | ⤷ Try for Free |
Canada | 2687124 | FORMULATIONS DE DOXEPINE A FAIBLE DOSE, INCLUANT DES FORMULATIONS BUCCALES, SUBLINGUALES ET A DISSOLUTION RAPIDE, ET LEURS UTILISATIONS POUR TRAITER L'INSOMNIE (LOW DOSE DOXEPIN FORMULATIONS, INCLUDING BUCCAL, SUBLINGUAL AND FASTMELT FORMULATIONS, AND USES OF THE SAME TO TREAT INSOMNIA) | ⤷ Try for Free |
European Patent Office | 2026792 | FORMULATIONS DE DOXÉPINE À FAIBLE DOSE, INCLUANT DES FORMULATIONS BUCCALES, SUBLINGUALES ET À DISSOLUTION RAPIDE, ET LEURS UTILISATIONS POUR TRAITER L'INSOMNIE (LOW DOSE DOXEPIN FORMULATIONS, INCLUDING BUCCAL, SUBLINGUAL AND FASTMELT FORMULATIONS, AND USES OF THE SAME TO TREAT INSOMNIA) | ⤷ Try for Free |
Germany | 69638015 | ⤷ Try for Free | |
Spain | 2199281 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for Silenor
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