Subsys is a drug owned by Btcp Pharma Llc. It is protected by 10 US drug patents filed from 2013 to 2020 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 27, 2030. Details of Subsys'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). | |||
| US8486973 | Sublingual fentanyl spray |
Apr, 2030
(5 years from now) | Active |
| US8486972 | Sublingual fentanyl spray |
Apr, 2030
(5 years from now) | Active |
| US9642797 | Sublingual fentanyl spray and methods of use to treat pain |
Jan, 2027
(2 years from now) | Active |
| US8835460 | Sublingual fentanyl spray and methods of treating pain |
Jan, 2027
(2 years from now) | Active |
| US9289387 | Method of treating pain by administering sublingual fentanyl spray |
Jan, 2027
(2 years from now) | Active |
| US9241935 | Sublingual fentanyl spray |
Jan, 2027
(2 years from now) | Active |
| US9642844 | Sublingual fentanyl spray |
Jan, 2027
(2 years from now) | Active |
| US8835459 | Sublingual fentanyl spray |
Jan, 2027
(2 years from now) | Active |
| US10610523 | Sublingual fentanyl spray |
Jan, 2027
(2 years from now) | Active |
| US10016403 | Sublingual fentanyl spray |
Jan, 2027
(2 years from now) | Active |
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 Subsys's patents.
Latest Legal Activities on Subsys's Patents
Given below is the list of recent legal activities going on the following patents of Subsys.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 13 May, 2024 | US10610523 |
| Expire Patent Critical | 29 Apr, 2024 | US9289387 |
| Maintenance Fee Reminder Mailed Critical | 27 Nov, 2023 | US10610523 |
| Maintenance Fee Reminder Mailed Critical | 13 Nov, 2023 | US9289387 |
| Expire Patent Critical | 24 Oct, 2022 | US8835460 |
| Expire Patent Critical | 15 Aug, 2022 | US10016403 |
| Maintenance Fee Reminder Mailed Critical | 10 May, 2022 | US8835460 |
| Maintenance Fee Reminder Mailed Critical | 28 Feb, 2022 | US10016403 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Jan, 2021 | US8486972 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Jan, 2021 | US8486973 |
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 Subsys and ongoing litigations to help you estimate the early arrival of Subsys generic.
Subsys's Litigations
Subsys been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 24, 2015, against patent number US8835460. The petitioner Coalition For Affordable Drugs XI LLC, challenged the validity of this patent, with Insys Pharma, Inc. as the respondent. Click below to track the latest information on how companies are challenging Subsys's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8486972 | August, 2015 |
Terminated-Denied
(10 Mar, 2016) | Insys Pharma, Inc. | Coalition For Affordable Drugs XI LLC |
| US8835459 | August, 2015 |
Terminated-Denied
(10 Mar, 2016) | Insys Pharma, Inc. | Coalition For Affordable Drugs XI LLC |
| US8835460 | August, 2015 |
Terminated-Denied
(10 Mar, 2016) | Insys Pharma, Inc. | Coalition For Affordable Drugs XI LLC |
FDA has granted some exclusivities to Subsys. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Subsys, 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 Subsys.
Exclusivity Information
Subsys holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Subsys's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jan 04, 2015 |
US patents provide insights into the exclusivity only within the United States, but Subsys 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 Subsys's family patents as well as insights into ongoing legal events on those patents.
Subsys's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Subsys's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 27, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Subsys Generic API suppliers:
Fentanyl is the generic name for the brand Subsys. 9 different companies have already filed for the generic of Subsys, with Mylan Technologies having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Subsys's generic
How can I launch a generic of Subsys before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Subsys's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Subsys'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 Subsys -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.4 mg/spray | 22 May, 2017 | 1 | 27 Apr, 2030 | ||
| 0.1 mg/spray, 0.2 mg/spray, 0.6 mg/spray, 0.8 mg/spray, 1.2 mg/spray, 1.6 mg/spray | 07 Dec, 2017 | 1 | 27 Apr, 2030 |
Alternative Brands for Subsys
Subsys which is used for managing pain., has several other brand drugs in the same treatment category and using the same active ingredient (Fentanyl). 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.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Fresenius Kabi Usa |
| |||
| Genus |
| |||
| Recro Gainesville |
| |||
| Tersera |
| |||
| Upjohn |
| |||
| Zyla |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Fentanyl. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Adalvo |
| |
| Btcp Pharma |
| |
| Cephalon |
| |
| Sentynl Theraps Inc |
| |
| The Medicines Co |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fentanyl, Subsys's active ingredient. Check the complete list of approved generic manufacturers for Subsys
About Subsys
Subsys is a drug owned by Btcp Pharma Llc. It is used for managing pain. Subsys uses Fentanyl as an active ingredient. Subsys was launched by Btcp Pharma in 2012.
Approval Date:
Subsys was approved by FDA for market use on 04 January, 2012.
Active Ingredient:
Subsys uses Fentanyl as the active ingredient. Check out other Drugs and Companies using Fentanyl ingredient
Treatment:
Subsys is used for managing pain.
Dosage:
Subsys is available in spray form for sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY | Discontinued | SUBLINGUAL |
| 1.6MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY | Discontinued | SUBLINGUAL |
| 0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY | Discontinued | SUBLINGUAL |
| 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY | Discontinued | SUBLINGUAL |
| 0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY | Discontinued | SUBLINGUAL |
| 0.8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY | Discontinued | SUBLINGUAL |
| 1.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SPRAY | Discontinued | SUBLINGUAL |