Fentanyl Patent Expiration
Fentanyl is Used for managing pain. It was first introduced by Janssen Pharmaceuticals Inc
Fentanyl Patents
Given below is the list of patents protecting Fentanyl, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Subsys | US8486972 | Sublingual fentanyl spray | Apr 27, 2030 | Btcp Pharma |
| Subsys | US8486973 | Sublingual fentanyl spray | Apr 27, 2030 | Btcp Pharma |
| Subsys | US10016403 | Sublingual fentanyl spray | Jan 25, 2027 | Btcp Pharma |
| Subsys | US10610523 | Sublingual fentanyl spray | Jan 25, 2027 | Btcp Pharma |
| Subsys | US8835459 | Sublingual fentanyl spray | Jan 25, 2027 | Btcp Pharma |
| Subsys | US8835460 | Sublingual fentanyl spray and methods of treating pain | Jan 25, 2027 | Btcp Pharma |
| Subsys | US9241935 | Sublingual fentanyl spray | Jan 25, 2027 | Btcp Pharma |
| Subsys | US9289387 | Method of treating pain by administering sublingual fentanyl spray | Jan 25, 2027 | Btcp Pharma |
| Subsys | US9642797 | Sublingual fentanyl spray and methods of use to treat pain | Jan 25, 2027 | Btcp Pharma |
| Subsys | US9642844 | Sublingual fentanyl spray | Jan 25, 2027 | Btcp Pharma |
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 Fentanyl's patents.
Latest Legal Activities on Fentanyl's Patents
Given below is the list recent legal activities going on the following patents of Fentanyl.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent | 18 Aug, 2025 | US8486972 |
| Expire Patent | 18 Aug, 2025 | US8486973 |
| Expire Patent | 16 Jun, 2025 | US9642797 |
| Expire Patent | 16 Jun, 2025 | US9642844 |
| Maintenance Fee Reminder Mailed | 03 Mar, 2025 | US8486973 |
| Maintenance Fee Reminder Mailed | 03 Mar, 2025 | US8486972 |
| Maintenance Fee Reminder Mailed | 30 Dec, 2024 | US9642844 |
| Maintenance Fee Reminder Mailed | 30 Dec, 2024 | US9642797 |
| Expire Patent Critical
| 13 May, 2024 | US10610523 |
| Expire Patent Critical
| 29 Apr, 2024 | US9289387 |
Fentanyl's Family Patents
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Clinical Trials
Recent Clinical Trials on Fentanyl:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
