Silenor is a drug owned by Currax Pharmaceuticals Llc. It is protected by 24 US drug patents filed from 2013 to 2024. Out of these, 16 drug patents are active and 8 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 07, 2030. Details of Silenor's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8513299 | Methods of using low-dose doxepin for the improvement of sleep |
Sep, 2030
(5 years from now) | Active |
| US9532971 | Low-dose doxepin formulations and methods of making and using the same |
Jun, 2029
(4 years from now) | Active |
| US9107898 | Methods of using low-dose doxepin for the improvement of sleep |
May, 2028
(3 years from now) | Active |
| US10548871 | Low-dose doxepin formulations and methods of making and using the same |
Apr, 2028
(3 years from now) | Active |
| US9907780 | Low-dose doxepin formulations and methods of making and using the same |
Apr, 2028
(3 years from now) | Active |
| US11096920 | Low-dose doxepin formulations and methods of making and using the same |
Apr, 2028
(3 years from now) | Active |
| US11234954 | Low-dose doxepin for treatment of sleep disorders in elderly patients |
Jan, 2028
(3 years from now) | Active |
| US7915307 | Methods of improving the pharmacokinetics of doxepin |
Aug, 2027
(2 years from now) | Active |
| US11110074 | Methods of improving the pharmacokinetics of doxepin |
Jul, 2027
(2 years from now) | Active |
| US10653660 | Methods of improving the pharmacokinetics of doxepin |
Jul, 2027
(2 years from now) | Active |
| US9572814 | Methods of improving the pharmacokinetics of doxepin |
Jul, 2027
(2 years from now) | Active |
| US10653662 | Methods of using low-dose doxepin for the improvement of sleep |
May, 2027
(2 years from now) | Active |
| US9486437 | Methods of using low-dose doxepin for the improvement of sleep |
May, 2027
(2 years from now) | Active |
| US10238620 | Methods of using low-dose doxepin for the improvement of sleep |
May, 2027
(2 years from now) | Active |
| US12083090 | Methods of using low-dose doxepin for the improvement of sleep |
May, 2027
(2 years from now) | Active |
| US9861607 | Methods of using low-dose doxepin for the improvement of sleep |
May, 2027
(2 years from now) | Active |
| US6211229 | Treatment of transient and short term insomnia |
Feb, 2020
(4 years ago) |
Expired
|
| US5585115 | Pharmaceutical excipient having improved compressability |
Jan, 2015
(9 years ago) |
Expired
|
| US6103219 | Pharmaceutical excipient having improved compressibility |
Jan, 2015
(9 years ago) |
Expired
|
| US5948438 | Pharmaceutical formulations having improved disintegration and/or absorptivity |
Jan, 2015
(9 years ago) |
Expired
|
| US5866166 | Pharmaceutical excipient having improved compressibility |
Jan, 2015
(9 years ago) |
Expired
|
| US6217909 | Pharmaceutical excipient having improved compressibility |
Jan, 2015
(9 years ago) |
Expired
|
| US5725884 | Pharmaceutical excipient having improved compressibility |
Jan, 2015
(9 years ago) |
Expired
|
| US5502047 | Treatment for insomnia |
Mar, 2013
(11 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Silenor's patents.
Latest Legal Activities on Silenor's Patents
Given below is the list of recent legal activities going on the following patents of Silenor.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 19 Jun, 2024 | US9532971 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 24 Apr, 2024 | US9486437 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 01 Nov, 2023 | US10653660 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 01 Nov, 2023 | US10653662 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 19 Jul, 2023 | US10548871 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 01 Feb, 2023 | US9107898 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 14 Sep, 2022 | US10238620 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 14 Sep, 2022 | US7915307 (Litigated) |
| Patent Issue Date Used in PTA Calculation Critical | 01 Feb, 2022 | US11234954 |
| Recordation of Patent Grant Mailed Critical | 01 Feb, 2022 | US11234954 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Silenor and ongoing litigations to help you estimate the early arrival of Silenor generic.
Silenor's Litigations
Silenor been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 08, 2011, against patent number US8513299. The petitioner , challenged the validity of this patent, with Roberta L. Rogowski et al as the respondent. Click below to track the latest information on how companies are challenging Silenor's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8513299 | August, 2011 |
Decision
(07 Dec, 2012) | Roberta L. Rogowski et al | |
FDA has granted some exclusivities to Silenor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Silenor, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Silenor.
Exclusivity Information
Silenor holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Silenor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 17, 2013 |
US patents provide insights into the exclusivity only within the United States, but Silenor is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Silenor's family patents as well as insights into ongoing legal events on those patents.
Silenor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Silenor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 07, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Silenor Generic API suppliers:
Doxepin Hydrochloride is the generic name for the brand Silenor. 36 different companies have already filed for the generic of Silenor, with Watson Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Silenor's generic
How can I launch a generic of Silenor before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Silenor's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Silenor's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Silenor -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 3 mg and 6 mg | 16 Sep, 2010 | 2 | 26 Jul, 2013 | 17 Feb, 2020 | Extinguished Eligible |
Alternative Brands for Silenor
Silenor which is used for treating insomnia., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
About Silenor
Silenor is a drug owned by Currax Pharmaceuticals Llc. It is used for treating insomnia. Silenor uses Doxepin Hydrochloride as an active ingredient. Silenor was launched by Currax in 2010.
Approval Date:
Silenor was approved by FDA for market use on 17 March, 2010.
Active Ingredient:
Silenor uses Doxepin Hydrochloride as the active ingredient. Check out other Drugs and Companies using Doxepin Hydrochloride ingredient
Treatment:
Silenor is used for treating insomnia.
Dosage:
Silenor is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 3MG BASE | TABLET | Prescription | ORAL |
| EQ 6MG BASE | TABLET | Prescription | ORAL |