Fentora is a drug owned by Cephalon Llc. It is protected by 9 US drug patents filed from 2013 to 2014. Out of these, 4 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 15, 2028. Details of Fentora'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8765100 | Transmucosal effervescent |
Mar, 2019
(5 years ago) |
Expired
|
| US6200604 | Sublingual buccal effervescent |
Mar, 2019
(5 years ago) |
Expired
|
| US6974590 | Sublingual buccal effervescent |
Mar, 2019
(5 years ago) |
Expired
|
| US8728441 | Sublingual buccal effervescent |
Mar, 2019
(5 years ago) |
Expired
|
| US8753611 | Sublingual buccal effervescent |
Mar, 2019
(5 years ago) |
Expired
|
| US8092832 | Generally linear effervescent oral fentanyl dosage form and methods of administering |
Dec, 2024
(3 months from now) | Active |
| US8119158 | Effervescent oral fentanyl dosage form and methods of administering fentanyl |
Dec, 2024
(3 months from now) | Active |
| US7862832 | Generally linear effervescent oral fentanyl dosage form and methods of administering |
Jun, 2028
(3 years from now) | Active |
| US7862833 | Effervescent oral opiate dosage forms and methods of administering opiates |
Jun, 2028
(3 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 Fentora's patents.
Latest Legal Activities on Fentora's Patents
Given below is the list of recent legal activities going on the following patents of Fentora.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Jul, 2023 | US8119158 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Jun, 2023 | US8092832 |
| Expire Patent Critical | 08 Aug, 2022 | US8765100 |
| Expire Patent Critical | 25 Jul, 2022 | US8753611 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Jun, 2022 | US7862832 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 27 Jun, 2022 | US7862833 (Litigated) |
| Maintenance Fee Reminder Mailed Critical | 21 Feb, 2022 | US8765100 |
| Maintenance Fee Reminder Mailed Critical | 07 Feb, 2022 | US8753611 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 13 Aug, 2019 | US8119158 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 02 Jul, 2019 | US8092832 |
US patents provide insights into the exclusivity only within the United States, but Fentora 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 Fentora's family patents as well as insights into ongoing legal events on those patents.
Fentora's Family Patents
Try Our Curated Drug Screens
Generic Launch
Generic Release Date:
Fentora's generic launch date based on the expiry of its last outstanding patent is estimated to be Jun 15, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Fentora Generics:
Fentanyl Citrate is the generic name for the brand Fentora. 9 different companies have already filed for the generic of Fentora, with Specgx Llc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Fentora's generic
How can I launch a generic of Fentora before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Fentora's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Fentora'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 Fentora -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.6 mg and 0.8 mg | 13 Nov, 2007 | 1 | 07 Jan, 2011 | 26 Mar, 2019 | Extinguished Deferred |
Fentora Competitors
Understanding your competition is essential for market success. Fentora which is used for managing breakthrough pain in cancer patients., has several other brand drugs in the same treatment category and using the same active ingredient (Fentanyl Citrate). 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 | ||
|---|---|---|---|---|
| Adalvo |
| |||
| Btcp Pharma |
| |||
| Sentynl Theraps Inc |
| |||
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fentanyl Citrate, Fentora's active ingredient. Check the complete list of approved generic manufacturers for Fentora
About Fentora
Fentora is a drug owned by Cephalon Llc. It is used for managing breakthrough pain in cancer patients. Fentora uses Fentanyl Citrate as an active ingredient. Fentora was launched by Cephalon in 2006.
Approval Date:
Fentora was approved by FDA for market use on 25 September, 2006.
Active Ingredient:
Fentora uses Fentanyl Citrate as the active ingredient. Check out other Drugs and Companies using Fentanyl Citrate ingredient
Treatment:
Fentora is used for managing breakthrough pain in cancer patients.
Dosage:
Fentora is available in tablet form for buccal, sublingual use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.4MG BASE | TABLET | Prescription | BUCCAL, SUBLINGUAL |
| EQ 0.6MG BASE | TABLET | Prescription | BUCCAL, SUBLINGUAL |
| EQ 0.2MG BASE | TABLET | Prescription | BUCCAL, SUBLINGUAL |
| EQ 0.1MG BASE | TABLET | Prescription | BUCCAL, SUBLINGUAL |
| EQ 0.8MG BASE | TABLET | Prescription | BUCCAL, SUBLINGUAL |
| EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | BUCCAL, SUBLINGUAL |