Buprenorphine Hydrochloride Patent Expiration
Buprenorphine Hydrochloride is Used for managing severe, long-term pain when other treatments are insufficient, through transmucosal delivery of buprenorphine. It was first introduced by Indivior Inc
Buprenorphine Hydrochloride Patents
Given below is the list of patents protecting Buprenorphine 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 |
|---|---|---|---|---|
| Belbuca | US6159498 | Bioerodable film for delivery of pharmaceutical compounds of mucosal surfaces |
Oct 18, 2016
(Expired) | Bdsi |
| Belbuca | US7579019 | Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces |
Jan 22, 2020
(Expired) | Bdsi |
| Belbuca | US8147866 | Transmucosal delivery devices with enhanced uptake | Jul 23, 2027 | Bdsi |
| Belbuca | US9655843 | Transmucosal delivery devices with enhanced uptake | Jul 23, 2027 | Bdsi |
| Belbuca | US9901539 | Transmucosal drug delivery devices for use in chronic pain relief | Dec 21, 2032 | Bdsi |
| Probuphine | US7736665 | Implantable polymeric device for sustained release of buprenorphine |
Apr 25, 2024
(Expired) | Reacx Pharms |
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Buprenorphine Hydrochloride Generics
Several generic applications have been filed for Buprenorphine Hydrochloride. The first generic version for Buprenorphine Hydrochloride was by Hospira Inc and was approved on Jun 3, 1996. And the latest generic version is by Alvogen Inc and was approved on Aug 3, 2021.
Given below is the list of companies who have filed for Buprenorphine Hydrochloride generic.
1. ACTAVIS ELIZABETH
Actavis Elizabeth Llc has filed for 2 different strengths of generic version for Buprenorphine 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 | tablet | Prescription | SUBLINGUAL | AB | Feb 19, 2015 |
| EQ 8MG BASE | tablet | Prescription | SUBLINGUAL | AB | Feb 19, 2015 |
2. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Buprenorphine 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 0.3MG BASE/ML | injectable | Prescription | INJECTION | AP | Mar 2, 2005 |
| EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Oct 8, 2009 |
| EQ 8MG BASE
(reference standard) | tablet | Prescription | SUBLINGUAL | AB | Oct 8, 2009 |
3. BARR
Barr Laboratories Inc has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride. Given below are the details of the strengths of this generic introduced by Barr.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 8MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | May 7, 2010 |
| EQ 2MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | May 7, 2010 |
4. HOSPIRA
Hospira Inc has filed for 1 generic for Buprenorphine Hydrochloride. 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 0.3MG BASE/ML | injectable | Prescription | INJECTION | AP | Jun 3, 1996 |
5. NORVIUM BIOSCIENCE
Norvium Bioscience Llc has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride. Given below are the details of the strengths of this generic introduced by Norvium Bioscience.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Mar 6, 2015 |
| EQ 8MG BASE | tablet | Discontinued | SUBLINGUAL | N/A | Mar 6, 2015 |
6. RHODES PHARMS
Rhodes Pharmaceuticals Lp has filed for 2 different strengths of generic version for Buprenorphine 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 | tablet | Prescription | SUBLINGUAL | AB | Mar 27, 2017 |
| EQ 8MG BASE | tablet | Prescription | SUBLINGUAL | AB | Mar 27, 2017 |
7. AM REGENT
American Regent Inc has filed for 1 generic for Buprenorphine Hydrochloride. Given below are the details of the strengths of this generic introduced by Am Regent.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.3MG BASE/ML | injectable | Discontinued | INJECTION | N/A | Mar 27, 2007 |
8. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Buprenorphine 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 8MG BASE | tablet | Prescription | SUBLINGUAL | AB | Jan 29, 2016 |
| EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Jan 29, 2016 |
9. ALVOGEN
Alvogen Inc has filed for 7 different strengths of generic version for Buprenorphine 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 0.3MG BASE | film | Discontinued | BUCCAL | N/A | Aug 3, 2021 |
| EQ 0.45MG BASE | film | Discontinued | BUCCAL | N/A | Aug 3, 2021 |
| EQ 0.6MG BASE | film | Discontinued | BUCCAL | N/A | Aug 3, 2021 |
| EQ 0.75MG BASE | film | Discontinued | BUCCAL | N/A | Aug 3, 2021 |
| EQ 0.9MG BASE | film | Discontinued | BUCCAL | N/A | Aug 3, 2021 |
| EQ 0.075MG BASE | film | Discontinued | BUCCAL | N/A | Aug 3, 2021 |
| EQ 0.15MG BASE | film | Discontinued | BUCCAL | N/A | Aug 3, 2021 |
10. ENDO OPERATIONS
Endo Operations Ltd has filed for 1 generic for Buprenorphine Hydrochloride. Given below are the details of the strengths of this generic introduced by Endo Operations.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 0.3MG BASE/ML
(reference standard) | injectable | Prescription | INJECTION | AP | Jul 28, 2015 |
11. ETHYPHARM
Ethypharm has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride. Given below are the details of the strengths of this generic introduced by Ethypharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Sep 24, 2010 |
| EQ 8MG BASE | tablet | Prescription | SUBLINGUAL | AB | Sep 24, 2010 |
12. RUBICON
Rubicon Research Private Ltd has filed for 2 different strengths of generic version for Buprenorphine Hydrochloride. Given below are the details of the strengths of this generic introduced by Rubicon.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| EQ 8MG BASE | tablet | Prescription | SUBLINGUAL | AB | Jun 10, 2015 |
| EQ 2MG BASE | tablet | Prescription | SUBLINGUAL | AB | Jun 10, 2015 |