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 Subsys, Duragesic-25, Duragesic-37, Duragesic-75, Duragesic-100, Duragesic-12. 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 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


Coming Soon

Patent Strength Analyzer

Will this be useful for you?

YesNo

Thank you for your response 🥳

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. 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


2. 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


3. 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


4. 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


5. 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


6. 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


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. 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


9. 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