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 in its drug Suboxone on Oct 8, 2002. Other drugs containing Buprenorphine Hydrochloride; Naloxone Hydrochloride are Zubsolv, Cassipa, Bunavail. 18 different companies have introduced drugs containing Buprenorphine Hydrochloride; Naloxone Hydrochloride.


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 US6159498 Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces Oct 18, 2016

(Expired)

Bdsi
Bunavail US7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces Jan 22, 2020

(Expired)

Bdsi
Bunavail US8147866 Transmucosal delivery devices with enhanced uptake Jul 23, 2027 Bdsi
Bunavail US8703177 Abuse-resistant mucoadhesive devices for delivery of buprenorphine Aug 20, 2032 Bdsi
Bunavail US9522188 Abuse resistant transmucosal drug delivery device Apr 24, 2035 Bdsi
Bunavail US9655843 Transmucosal delivery devices with enhanced uptake Jul 23, 2027 Bdsi
Suboxone US10285910 Sublingual and buccal film compositions Oct 11, 2022

(Expired)

Indivior
Suboxone US11135216 Sublingual and buccal film compositions Aug 07, 2029 Indivior
Suboxone US8017150 Polyethylene oxide-based films and drug delivery systems made therefrom Feb 13, 2023

(Expired)

Indivior
Suboxone US8475832 Sublingual and buccal film compositions Mar 26, 2030 Indivior
Suboxone US8603514 Uniform films for rapid dissolve dosage form incorporating taste-masking compositions Apr 03, 2024

(Expired)

Indivior
Suboxone US9687454 Sublingual and buccal film compositions Aug 07, 2029 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
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 US8454996 Pharmaceutical composition for the treatment of acute disorders Sep 24, 2019

(Expired)

Orexo Us Inc
Zubsolv US8470361 Non-abusable pharmaceutical composition comprising opioids May 22, 2030 Orexo Us Inc
Zubsolv US8658198 Non-abusable pharmaceutical composition comprising opioids Dec 03, 2027 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


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Buprenorphine Hydrochloride; Naloxone Hydrochloride Generics

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 Aveva Drug Delivery Systems Inc and was approved on Jun 2, 2022.

Given below is the list of companies who have filed for Buprenorphine Hydrochloride; Naloxone Hydrochloride generic.


1. 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


2. 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


3. 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


4. 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


5. 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


6. 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


7. 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


8. 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


9. 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


10. 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


11. 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


12. 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


13. 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


14. AVEVA

Aveva Drug Delivery Systems 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 Aveva.

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


15. 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