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 | US10016403 | Sublingual fentanyl spray | Jan 25, 2027 | Btcp Pharma |
| Subsys | US10610523 | Sublingual fentanyl spray | Jan 25, 2027 | Btcp Pharma |
| Subsys | US8486972 | Sublingual fentanyl spray | Apr 27, 2030 | Btcp Pharma |
| Subsys | US8486973 | Sublingual fentanyl spray | Apr 27, 2030 | 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.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| 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 |
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Fentanyl Generics
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.
1. NOVEN
Noven Pharmaceuticals Inc has filed for 4 different strengths of generic version for Fentanyl. Out of these 75mcg/hr version comes by the name FENTANYL-75, 100mcg/hr version comes by the name FENTANYL-100, 25mcg/hr version comes by the name FENTANYL-25, 50mcg/hr version comes by the name FENTANYL-50. Given below are the details of the strengths of this generic introduced by Noven.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 75MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Oct 16, 2009 |
| 100MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Oct 16, 2009 |
| 25MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Oct 16, 2009 |
| 50MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Oct 16, 2009 |
2. SPECGX LLC
Specgx Llc has filed for 7 different strengths of generic version for Fentanyl. Out of these 25mcg/hr version comes by the name FENTANYL-25, 100mcg/hr version comes by the name FENTANYL-100, 75mcg/hr version comes by the name FENTANYL-75, 50mcg/hr version comes by the name FENTANYL-50, 12.5mcg/hr version comes by the name FENTANYL-12, 62.5mcg/hr version comes by the name FENTANYL-62, 37.5mcg/hr version comes by the name FENTANYL-37. Given below are the details of the strengths of this generic introduced by Specgx Llc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MCG/HR
(reference standard) | film, extended release | Prescription | TRANSDERMAL | AB | Feb 9, 2011 |
| 100MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Feb 9, 2011 |
| 75MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Feb 9, 2011 |
| 50MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Feb 9, 2011 |
| 12.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Jun 11, 2015 |
| 62.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Jan 14, 2020 |
| 37.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Jan 14, 2020 |
3. ACTAVIS LABS UT INC
Actavis Laboratories Ut Inc Indirect Wholly Owned Sub Of Teva Pharmaceuticals Usa Inc has filed for 4 different strengths of generic version for Fentanyl. Out of these 25mcg/hr version comes by the name FENTANYL-25, 50mcg/hr version comes by the name FENTANYL-50, 75mcg/hr version comes by the name FENTANYL-75, 100mcg/hr version comes by the name FENTANYL-100. Given below are the details of the strengths of this generic introduced by Actavis Labs Ut Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 25MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 20, 2007 |
| 50MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 20, 2007 |
| 75MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 20, 2007 |
| 100MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 20, 2007 |
4. MAYNE PHARMA
Mayne Pharma Llc has filed for 4 different strengths of generic version for Fentanyl. Out of these 50mcg/hr version comes by the name FENTANYL-50, 25mcg/hr version comes by the name FENTANYL-25, 75mcg/hr version comes by the name FENTANYL-75, 100mcg/hr version comes by the name FENTANYL-100. Given below are the details of the strengths of this generic introduced by Mayne Pharma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 20, 2007 |
| 25MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 20, 2007 |
| 75MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 20, 2007 |
| 100MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 20, 2007 |
5. KINDEVA
Kindeva Drug Delivery Lp has filed for 5 different strengths of generic version for Fentanyl. Out of these 75mcg/hr version comes by the name FENTANYL-75, 12.5mcg/hr version comes by the name FENTANYL-12, 25mcg/hr version comes by the name FENTANYL-25, 50mcg/hr version comes by the name FENTANYL-50, 100mcg/hr version comes by the name FENTANYL-100. Given below are the details of the strengths of this generic introduced by Kindeva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 75MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Nov 4, 2016 |
| 12.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Nov 4, 2016 |
| 25MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Nov 4, 2016 |
| 50MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Nov 4, 2016 |
| 100MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Nov 4, 2016 |
6. MYLAN TECHNOLOGIES
Mylan Technologies Inc has filed for 8 different strengths of generic version for Fentanyl. Out of these 50mcg/hr version comes by the name FENTANYL-50, 25mcg/hr version comes by the name FENTANYL-25, 75mcg/hr version comes by the name FENTANYL-75, 100mcg/hr version comes by the name FENTANYL-100, 12.5mcg/hr version comes by the name FENTANYL-12, 87.5mcg/hr version comes by the name FENTANYL-87, 37.5mcg/hr version comes by the name FENTANYL-37, 62.5mcg/hr version comes by the name FENTANYL-62. Given below are the details of the strengths of this generic introduced by Mylan Technologies.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Jan 28, 2005 |
| 25MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Jan 28, 2005 |
| 75MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Jan 28, 2005 |
| 100MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Jan 28, 2005 |
| 12.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Jan 23, 2007 |
| 87.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Dec 29, 2014 |
| 37.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Dec 29, 2014 |
| 62.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Dec 29, 2014 |
7. AVEVA
Aveva Drug Delivery Systems Inc has filed for 8 different strengths of generic version for Fentanyl. Out of these 50mcg/hr version comes by the name FENTANYL-50, 25mcg/hr version comes by the name FENTANYL-25, 100mcg/hr version comes by the name FENTANYL-100, 75mcg/hr version comes by the name FENTANYL-75, 12.5mcg/hr version comes by the name FENTANYL-12, 62.5mcg/hr version comes by the name FENTANYL-62, 37.5mcg/hr version comes by the name FENTANYL-37, 87.5mcg/hr version comes by the name FENTANYL-87. Given below are the details of the strengths of this generic introduced by Aveva.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 50MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Oct 20, 2008 |
| 25MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Oct 20, 2008 |
| 100MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Oct 20, 2008 |
| 75MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Oct 20, 2008 |
| 12.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Sep 11, 2015 |
| 62.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Dec 6, 2017 |
| 37.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Dec 6, 2017 |
| 87.5MCG/HR | film, extended release | Prescription | TRANSDERMAL | AB | Dec 6, 2017 |
8. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 8 different strengths of generic version for Fentanyl. Out of these 75mcg/hr version comes by the name FENTANYL-75, 87.5mcg/hr version comes by the name FENTANYL-87, 100mcg/hr version comes by the name FENTANYL-100, 12.5mcg/hr version comes by the name FENTANYL-12, 25mcg/hr version comes by the name FENTANYL-25, 37.5mcg/hr version comes by the name FENTANYL-37, 50mcg/hr version comes by the name FENTANYL-50, 62.5mcg/hr version comes by the name FENTANYL-62. Given below are the details of the strengths of this generic introduced by Zydus Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 75MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Jan 24, 2023 |
| 87.5MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Jan 24, 2023 |
| 100MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Jan 24, 2023 |
| 12.5MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Jan 24, 2023 |
| 25MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Jan 24, 2023 |
| 37.5MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Jan 24, 2023 |
| 50MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Jan 24, 2023 |
| 62.5MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Jan 24, 2023 |
9. LAVIPHARM LABS
Lavipharm Laboratories Inc has filed for 4 different strengths of generic version for Fentanyl. Out of these 75mcg/hr version comes by the name FENTANYL-75, 50mcg/hr version comes by the name FENTANYL-50, 25mcg/hr version comes by the name FENTANYL-25, 100mcg/hr version comes by the name FENTANYL-100. Given below are the details of the strengths of this generic introduced by Lavipharm Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 75MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 4, 2006 |
| 50MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 4, 2006 |
| 25MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 4, 2006 |
| 100MCG/HR | film, extended release | Discontinued | TRANSDERMAL | N/A | Aug 4, 2006 |