Fentanyl Citrate Patent Expiration
Fentanyl Citrate is Used for managing breakthrough pain in cancer patients who are already receiving and tolerant to opioid therapy. It was first introduced by Rising Pharma Holdings Inc
Fentanyl Citrate Patents
Given below is the list of patents protecting Fentanyl Citrate, 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 |
|---|---|---|---|---|
| Abstral | US6759059 | Fentanyl composition for the treatment of acute pain |
Sep 24, 2019
(Expired) | Sentynl Theraps Inc |
| Abstral | US6761910 | Pharmaceutical composition for the treatment of acute disorders |
Sep 24, 2019
(Expired) | Sentynl Theraps Inc |
| Abstral | US7910132 | Pharmaceutical composition for the treatment of acute disorders |
Sep 24, 2019
(Expired) | Sentynl Theraps Inc |
| Fentora | US6200604 | Sublingual buccal effervescent |
Mar 26, 2019
(Expired) | Cephalon |
| Fentora | US6974590 | Sublingual buccal effervescent |
Mar 26, 2019
(Expired) | Cephalon |
| Fentora | US7862832 | Generally linear effervescent oral fentanyl dosage form and methods of administering | Jun 15, 2028 | Cephalon |
| Fentora | US7862833 | Effervescent oral opiate dosage forms and methods of administering opiates | Jun 15, 2028 | Cephalon |
| Fentora | US8092832 | Generally linear effervescent oral fentanyl dosage form and methods of administering | Dec 30, 2024 | Cephalon |
| Fentora | US8119158 | Effervescent oral fentanyl dosage form and methods of administering fentanyl | Dec 30, 2024 | Cephalon |
| Fentora | US8728441 | Sublingual buccal effervescent |
Mar 26, 2019
(Expired) | Cephalon |
| Fentora | US8753611 | Sublingual buccal effervescent |
Mar 26, 2019
(Expired) | Cephalon |
| Fentora | US8765100 | Transmucosal effervescent |
Mar 26, 2019
(Expired) | Cephalon |
| Lazanda | US6432440 | Pectin compositions and methods of use for improved delivery of drugs to mucosal surfaces |
Apr 20, 2018
(Expired) | Btcp Pharma |
| Lazanda | US8216604 | Method of managing or treating pain | Oct 03, 2024 | Btcp Pharma |
| Lazanda | US8889176 | Method of managing or treating pain |
Jan 16, 2024
(Expired) | Btcp Pharma |
| Lazanda | US9078814 | Intranasal spray device containing pharmaceutical composition |
Jan 08, 2024
(Expired) | Btcp Pharma |
| Lazanda | US9731869 | Container | Jan 26, 2032 | Btcp Pharma |
| Lazanda | US9814705 | Intranasal spray device containing pharmaceutical composition |
Jan 08, 2024
(Expired) | Btcp Pharma |
| Onsolis | US6159498 | Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces |
Oct 18, 2016
(Expired) | Adalvo |
| Onsolis | US7579019 | Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces |
Jan 22, 2020
(Expired) | Adalvo |
| Onsolis | US9579288 | Tesofensine and beta blocker combination formulations | Jul 23, 2027 | Adalvo |
| Onsolis | US9597288 | Transmucosal delivery devices with enhanced uptake | Jul 23, 2027 | Adalvo |
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Fentanyl Citrate Generics
Several generic applications have been filed for Fentanyl Citrate. The first generic version for Fentanyl Citrate was by Abbott Laboratories Hosp Products Div and was approved on Apr 30, 1990. And the latest generic version is by Dr Reddys Laboratories Sa and was approved on Aug 22, 2022.
Given below is the list of companies who have filed for Fentanyl Citrate generic.
1. SPECGX LLC
Specgx Llc has filed for 6 different strengths of generic version for Fentanyl Citrate. 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 |
|---|---|---|---|---|---|
| EQ 0.2MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
| EQ 0.4MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
| EQ 0.6MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
| EQ 0.8MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
| EQ 1.2MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
| EQ 1.6MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
2. DR REDDYS
Dr Reddys Laboratories Ltd has filed for 1 generic for Fentanyl Citrate. This eq 0.05mg base/ml version comes by the name FENTANYL CITRATE PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Dr Reddys.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.05MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Feb 3, 1998 |
3. WATSON LABS
Watson Laboratories Inc has filed for 6 different strengths of generic version for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Watson Labs.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.05MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Jun 30, 1992 |
| EQ 0.6MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Jan 7, 2011 |
| EQ 0.2MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Jan 7, 2011 |
| EQ 0.4MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Jan 7, 2011 |
| EQ 0.8MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Jan 7, 2011 |
| EQ 0.1MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Jan 7, 2011 |
4. HOSPIRA
Hospira Inc has filed for 1 generic for Fentanyl Citrate. This eq 0.05mg base/ml version comes by the name FENTANYL CITRATE PRESERVATIVE FREE. Given below are the details of the strengths of this generic introduced by Hospira.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.05MG BASE/ML | injectable | Prescription | INJECTION | AP | Sep 24, 1991 |
5. FRESENIUS KABI USA
Fresenius Kabi Usa Llc has filed for 1 generic for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Fresenius Kabi Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.05MG BASE/ML | injectable | Prescription | INJECTION | AP | Sep 1, 2020 |
6. PAR PHARM
Par Pharmaceutical Inc has filed for 6 different strengths of generic version for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Par Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.2MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
| EQ 0.4MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
| EQ 0.6MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
| EQ 0.8MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
| EQ 1.2MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
| EQ 1.6MG BASE | troche/lozenge | Discontinued | TRANSMUCOSAL | N/A | Oct 30, 2009 |
7. ABBOTT
Abbott Laboratories Hosp Products Div has filed for 1 generic for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Abbott.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.05MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Apr 30, 1990 |
8. DR REDDYS LABS SA
Dr Reddys Laboratories Sa has filed for 6 different strengths of generic version for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Dr Reddys Labs Sa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.2MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Aug 22, 2022 |
| EQ 0.1MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Aug 22, 2022 |
| EQ 0.4MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Aug 22, 2022 |
| EQ 0.3MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Aug 22, 2022 |
| EQ 0.8MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Aug 22, 2022 |
| EQ 0.6MG BASE | tablet | Discontinued | BUCCAL, SUBLINGUAL | N/A | Aug 22, 2022 |
9. ACTAVIS LABS FL INC
Actavis Laboratories Fl Inc has filed for 6 different strengths of generic version for Fentanyl Citrate. Given below are the details of the strengths of this generic introduced by Actavis Labs Fl Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.2MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Nov 17, 2017 |
| EQ 0.3MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Nov 17, 2017 |
| EQ 0.4MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Nov 17, 2017 |
| EQ 0.6MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Nov 17, 2017 |
| EQ 0.8MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Nov 17, 2017 |
| EQ 0.1MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Nov 17, 2017 |