Buprenorphine Hydrochloride; Naloxone Hydrochloride Patent Expiration
Buprenorphine Hydrochloride; Naloxone Hydrochloride is used for treating opioid dependence and opioid use disorder. It was first introduced by Indivior Inc
Buprenorphine Hydrochloride; Naloxone Hydrochloride Patents
Given below is the list of patents protecting Buprenorphine Hydrochloride; Naloxone Hydrochloride, 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 |
|---|---|---|---|---|
| Bunavail | US9522188 | Abuse resistant transmucosal drug delivery device | Apr 24, 2035 | Bdsi |
| Zubsolv | US10874661 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence | Sep 18, 2032 | Orexo Us Inc |
| Zubsolv | US10946010 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence | Sep 18, 2032 | Orexo Us Inc |
| Zubsolv | US11020387 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence | Sep 18, 2032 | Orexo Us Inc |
| Zubsolv | US11020388 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence | Sep 18, 2032 | Orexo Us Inc |
| Zubsolv | US11433066 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence | Sep 18, 2032 | Orexo Us Inc |
| Zubsolv | US8940330 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence | Sep 18, 2032 | Orexo Us Inc |
| Zubsolv | US9259421 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence | Sep 18, 2032 | Orexo Us Inc |
| Zubsolv | US9439900 | Abuse-resistant pharmaceutical composition for the treatment of opioid dependence | Sep 18, 2032 | Orexo Us Inc |
| Bunavail | US8703177 | Abuse-resistant mucoadhesive devices for delivery of buprenorphine | Aug 20, 2032 | Bdsi |
| Zubsolv | US8470361 | Non-abusable pharmaceutical composition comprising opioids | May 22, 2030 | Orexo Us Inc |
| Suboxone | US8475832 | Sublingual and buccal film compositions | Mar 26, 2030 | Indivior |
| Suboxone | US11135216 | Sublingual and buccal film compositions | Aug 07, 2029 | Indivior |
| Suboxone | US9687454 | Sublingual and buccal film compositions | Aug 07, 2029 | Indivior |
| Zubsolv | US8658198 | Non-abusable pharmaceutical composition comprising opioids | Dec 03, 2027 | Orexo Us Inc |
| Bunavail | US8147866 | Transmucosal delivery devices with enhanced uptake | Jul 23, 2027 | Bdsi |
| Bunavail | US9655843 | Transmucosal delivery devices with enhanced uptake | Jul 23, 2027 | Bdsi |
| Suboxone | US8603514 | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
Apr 03, 2024
(Expired) | Indivior |
| Suboxone | US8017150 | Polyethylene oxide-based films and drug delivery systems made therefrom |
Feb 13, 2023
(Expired) | Indivior |
| Suboxone | US10285910 | Sublingual and buccal film compositions |
Oct 11, 2022
(Expired) | Indivior |
| Suboxone | US9855221 | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
Feb 14, 2022
(Expired) | Indivior |
| Suboxone | US9931305 | Uniform films for rapid dissolve dosage form incorporating taste-masking compositions |
Feb 14, 2022
(Expired) | Indivior |
| Bunavail | US7579019 | Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces |
Jan 22, 2020
(Expired) | Bdsi |
| Zubsolv | US8454996 | Pharmaceutical composition for the treatment of acute disorders |
Sep 24, 2019
(Expired) | Orexo Us Inc |
| Bunavail | US6159498 | Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces |
Oct 18, 2016
(Expired) | Bdsi |
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 Buprenorphine Hydrochloride; Naloxone Hydrochloride's patents.
Latest Legal Activities on Buprenorphine Hydrochloride; Naloxone Hydrochloride's Patents
Given below is the list recent legal activities going on the following patents of Buprenorphine Hydrochloride; Naloxone Hydrochloride.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 24 Jun, 2024 | US10874661 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Mar, 2024 | US9439900(Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 09 Aug, 2023 | US9259421(Litigated) |
| Expire Patent Critical | 19 Jun, 2023 | US10285910 |
| Maintenance Fee Reminder Mailed Critical | 02 Jan, 2023 | US10285910 |
| Review Certificate Mailed | 30 Sep, 2022 | US9687454(Litigated) |
| Review Certificate | 23 Sep, 2022 | US9687454(Litigated) |
| Recordation of Patent Grant Mailed Critical | 06 Sep, 2022 | US11433066 |
| Patent Issue Date Used in PTA Calculation Critical | 06 Sep, 2022 | US11433066 |
| Email Notification Critical | 18 Aug, 2022 | US11433066 |
Buprenorphine Hydrochloride; Naloxone Hydrochloride's Family Patents
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Buprenorphine Hydrochloride; Naloxone Hydrochloride Generic API Manufacturers
Several generic applications have been filed for Buprenorphine Hydrochloride; Naloxone Hydrochloride. The first generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride was by Amneal Pharmaceuticals Of New York Llc and was approved on Feb 22, 2013. And the latest generic version is by Difgen Pharmaceuticals Llc and was approved on Jun 2, 2022.
Given below is the list of companies who have filed for Buprenorphine Hydrochloride; Naloxone Hydrochloride generic, along with the locations of their manufacturing plants worldwide.
1. ACTAVIS ELIZABETH
Actavis Elizabeth Llc has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Actavis Elizabeth.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Prescription | SUBLINGUAL | AB | Feb 22, 2013 |
| EQ 8MG BASE; EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Feb 22, 2013 |
Manufacturing Plant Locations New
Actavis Elizabeth's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Actavis Elizabeth as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
2. ALKEM LABS LTD
Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Prescription | SUBLINGUAL | AB | Jun 15, 2021 |
| EQ 8MG BASE; EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Jun 15, 2021 |
3. ALVOGEN
Alvogen Inc has filed for 4 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Alvogen.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 12MG BASE; EQ 3MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Jan 24, 2019 |
| EQ 4MG BASE; EQ 1MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Jan 24, 2019 |
| EQ 2MG BASE; EQ 0.5MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Jan 24, 2019 |
| EQ 8MG BASE; EQ 2MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Jan 24, 2019 |
Manufacturing Plant Locations New
Alvogen's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Alvogen as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
4. AMNEAL PHARMS
Amneal Pharmaceuticals Of New York Llc has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Amneal Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Prescription | SUBLINGUAL | AB | Feb 22, 2013 |
| EQ 8MG BASE; EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Feb 22, 2013 |
5. DIFGEN PHARMS
Difgen Pharmaceuticals Llc has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Difgen Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 8MG BASE; EQ 2MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Jun 2, 2022 |
| EQ 12MG BASE; EQ 3MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Jun 2, 2022 |
6. DR REDDYS LABS SA
Dr Reddys Laboratories Sa has filed for 4 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. 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 4MG BASE; EQ 1MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Jun 14, 2018 |
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Jul 17, 2020 |
| EQ 8MG BASE; EQ 2MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Jul 17, 2020 |
| EQ 12MG BASE; EQ 3MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Jun 14, 2018 |
7. ETHYPHARM USA CORP
Ethypharm Usa Corp has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Ethypharm Usa Corp.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Prescription | SUBLINGUAL | AB | Oct 16, 2015 |
| EQ 8MG BASE; EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Oct 16, 2015 |
Manufacturing Plant Locations New
Ethypharm Usa Corp's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Ethypharm Usa Corp as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
8. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 8MG BASE; EQ 2MG BASE
(reference standard) | tablet | Prescription | SUBLINGUAL | AB | Jun 27, 2014 |
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Prescription | SUBLINGUAL | AB | Jun 27, 2014 |
Manufacturing Plant Locations New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||
| Portugal |
| |||||||||
| Jordan |
| |||||||||
9. LANNETT CO INC
Lannett Co Inc has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Lannett Co Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Prescription | SUBLINGUAL | AB | Sep 19, 2016 |
| EQ 8MG BASE; EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Sep 19, 2016 |
10. MYLAN TECHNOLOGIES
Mylan Technologies Inc has filed for 4 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. 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 |
|---|---|---|---|---|---|
| EQ 8MG BASE; EQ 2MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Jun 14, 2018 |
| EQ 12MG BASE; EQ 3MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Jun 14, 2018 |
| EQ 2MG BASE; EQ 0.5MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Apr 17, 2020 |
| EQ 4MG BASE; EQ 1MG BASE | film | Prescription | BUCCAL, SUBLINGUAL | AB | Apr 17, 2020 |
Manufacturing Plant Locations New
Mylan Technologies's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Mylan Technologies as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||
11. RHODES PHARMS
Rhodes Pharmaceuticals Lp has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Rhodes Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Prescription | SUBLINGUAL | AB | Mar 30, 2020 |
| EQ 8MG BASE; EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Mar 30, 2020 |
12. SPECGX LLC
Specgx Llc has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. 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 8MG BASE; EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Dec 13, 2017 |
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Prescription | SUBLINGUAL | AB | Dec 13, 2017 |
Manufacturing Plant Locations New
Specgx Llc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Specgx Llc as present at those locations.
| Country | City | Firm Name | ||||||
|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||
13. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Prescription | SUBLINGUAL | AB | Aug 5, 2016 |
| EQ 8MG BASE; EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Aug 5, 2016 |
Manufacturing Plant Locations New
Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
| |||||||||||||||||||||||||||||
| India |
| |||||||||||||||||||||||||||||
14. TEVA PHARMS USA
Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Sep 8, 2014 |
| EQ 8MG BASE; EQ 2MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Sep 8, 2014 |
15. WES PHARMA INC
Wes Pharma Inc has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride; Naloxone Hydrochloride. All of these versions come by the name BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE. Given below are the details of the strengths of this generic introduced by Wes Pharma Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE; EQ 0.5MG BASE | tablet | Prescription | SUBLINGUAL | AB | Jul 17, 2020 |
| EQ 8MG BASE; EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Jul 17, 2020 |
Manufacturing Plant Locations New
Wes Pharma Inc's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Wes Pharma Inc as present at those locations.
| Country | City | Firm Name | ||
|---|---|---|---|---|
| United States |
| |||