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 in its drug Buprenex on Approved Prior to Jan 1, 1982. Other drugs containing Buprenorphine Hydrochloride are Belbuca, Probuphine, Subutex. 15 different companies have introduced drugs containing Buprenorphine Hydrochloride.


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 US9901539 Transmucosal drug delivery devices for use in chronic pain relief Dec 21, 2032 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
Probuphine US7736665 Implantable polymeric device for sustained release of buprenorphine Apr 25, 2024

(Expired)

Reacx Pharms
Belbuca US7579019 Pharmaceutical carrier device suitable for delivery of pharmaceutical compounds to mucosal surfaces Jan 22, 2020

(Expired)

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

(Expired)

Bdsi



Buprenorphine Hydrochloride's Family Patents

Family Patents

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Buprenorphine Hydrochloride Generic API Manufacturers

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, 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. 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


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
Elizabeth Actavis Elizabeth LLC, A Company of Teva





2. 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


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
Morristown Alvogen, Inc





3. 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





4. 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


Manufacturing Plant Locations
New

Barr's manufacturing plants are situated in 4 countries - Mexico, Singapore, United States, Philippines. Given below are the details of these plant locations as well as the firm names of Barr as present at those locations.

Country City Firm Name
Mexico
Aldama Barra La Coma, S. De R.L
Singapore
Singapore Barramundi Asia Pte Ltd
United States
Memphis Barrett Distribution Centers
Franklin Barrett Distribution Centers, Inc.
Arecibo Barreto Dairy, Inc.
Greenwood Barr Enterprises, Inc.
Commerce Barreras Meat Co
Newton Barrett Technology, LLC
Somerset Barrett Distribution Centers Inc
Hereford Barrett and Crofoot, LLP
Buffalo Barrel and Brine Inc
Barrett Barrett Farm Supply, Inc.
Randolph Barrett Farm
Lake Barrington Barrington Ventures, Ltd
Curtis Bay Barrett Distribution Center
Belvidere Barred Woods, LLC
Live Oak Barrington Dairy Farm
Forest Barr Laboratories Inc.
Brainerd Barrett Ag Service, Inc.
Paso Robles Barreto Cellars
Swartz Creek Barrett Donut Mixes, Inc..
Hereford Barrett and Crofoot Feedyard, West
Davie Barrier Technologies LLC
Englewood Barrett E. Cowan, MD
Harrison Barrington Chemical Corporation
Madison Barriques Holding Company, LLC
Dillon Barretts Minerals Inc
Machipongo Barrier Island Seafood
Montezuma Barrington Dairies
Lee Barrington Coffee Roasting Company, Inc.
Philippines
Bulacan Barrio Fiesta Manufacturing Corporation





5. 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





6. 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


Manufacturing Plant Locations
New

Ethypharm's manufacturing plants are situated in 2 countries - France, United States. Given below are the details of these plant locations as well as the firm names of Ethypharm as present at those locations.

Country City Firm Name
France
Chateauneuf En Thymerais Ethypharm
Le Grand Quevilly CEDEX Ethypharm
United States
Philadelphia Ethypharm Usa Corp





7. 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


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
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





8. 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


Manufacturing Plant Locations
New

Hospira's manufacturing plants are situated in 3 countries - Australia, United States, Dominican Republic (the). Given below are the details of these plant locations as well as the firm names of Hospira as present at those locations.

Country City Firm Name
Australia
Mulgrave Hospira Australia Pty Ltd.
United States
Rocky Mount Hospira, Inc.
Clayton Hospira, Inc.
Morgan Hill Hospira Inc
Mcpherson Hospira, Inc., A Pfizer Company
Lake Forest Hospira Inc
Pleasant Prairie Hospira Worldwide, LLC d.b.a. Hospira, a Pfizer-owned Company
Dominican Republic (the)
Haina, San Cristobal Hospira, Ltd.





9. 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





10. 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





11. 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


Manufacturing Plant Locations
New

Rubicon's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Rubicon as present at those locations.

Country City Firm Name
United States
Geismar Rubicon, LLC
Indianapolis Rubicon Foods LLC
Canada
Concord Rubicon Research Canada Limited
India
Ambarnath Rubicon Research Private Limited





12. 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


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
Lexington Sun Pharmaceutical Industries Inc
Billerica Sun Pharmaceutical Industries, Inc.
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
India
Halol Sun Pharmaceutical Industries Ltd.
New Delhi Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Mohali Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Baruch Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Dadra Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd