Fentanyl Patent Expiration

Fentanyl is Used for managing pain. It was first introduced by Janssen Pharmaceuticals Inc in its drug Duragesic-50 on Aug 7, 1990. Other drugs containing Fentanyl are Duragesic-12, Duragesic-100, Duragesic-37, Subsys, Duragesic-75, Duragesic-25. 11 different companies have introduced drugs containing Fentanyl.


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.

Given below is the list recent legal activities going on the following patents of Fentanyl.

Activity Date Patent Number
Patent litigations
Expire Patent 13 May, 2024 US10610523
Expire Patent 29 Apr, 2024 US9289387
Maintenance Fee Reminder Mailed 27 Nov, 2023 US10610523
Maintenance Fee Reminder Mailed 13 Nov, 2023 US9289387
Expire Patent 24 Oct, 2022 US8835460
Expire Patent 15 Aug, 2022 US10016403
Maintenance Fee Reminder Mailed 10 May, 2022 US8835460
Maintenance Fee Reminder Mailed 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


Fentanyl's Family Patents

Family Patents

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Fentanyl Generic API Manufacturers

Several generic applications have been filed for Fentanyl. The first generic version for Fentanyl was by Mylan Technologies Inc and was approved on Jan 28, 2005. And the latest generic version is by Zydus Pharmaceuticals Usa Inc and was approved on Jan 24, 2023.

Given below is the list of companies who have filed for Fentanyl generic, along with the locations of their manufacturing plants worldwide.


Fentanyl News

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