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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 Subutex, Probuphine, Belbuca. 16 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.
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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 Somerset Therapeutics Llc and was approved on Jan 30, 2025.
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 0.45MG 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 0.3MG 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
Brainerd
Barrett Ag Service, Inc.
Franklin
Barrett Distribution Centers, Inc.
Montezuma
Barrington Dairies
Arecibo
Barreto Dairy, Inc.
Greenwood
Barr Enterprises, Inc.
Memphis
Barrett Distribution Centers
Lake Barrington
Barrington Ventures, Ltd
Swartz Creek
Barrett Donut Mixes, Inc..
Hereford
Barrett and Crofoot Feedyard, West
Englewood
Barrett E. Cowan, MD
Harrison
Barrington Chemical Corporation
Madison
Barriques Holding Company, LLC
Machipongo
Barrier Island Seafood
Commerce
Barreras Meat Co
Hereford
Barrett and Crofoot, LLP
Lee
Barrington Coffee Roasting Company, Inc.
Somerset
Barrett Distribution Centers Inc
Paso Robles
Barreto Cellars
Forest
Barr Laboratories Inc.
Newton
Barrett Technology, LLC
Dillon
Barretts Minerals Inc
Belvidere
Barred Woods, LLC
Davie
Barrier Technologies LLC
Live Oak
Barrington Dairy Farm
Curtis Bay
Barrett Distribution Center
Barrett
Barrett Farm Supply, Inc.
Buffalo
Barrel and Brine Inc
Randolph
Barrett Farm
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
Le Grand Quevilly CEDEX
Ethypharm
Chateauneuf En Thymerais
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
Cherry Hill
Hikma Pharmaceuticals USA Inc.
Eatontown
Hikma Pharmaceuticals USA, Inc.
Carlsbad
Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton
Hikma Injectables USA Inc
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
Clayton
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
Rocky Mount
Hospira, Inc.
Morgan Hill
Hospira Inc
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 8MG BASE
tablet
Prescription
SUBLINGUAL
AB
Mar 27, 2017
EQ 2MG 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. SOMERSET THERAPS LLC
Somerset Therapeutics Llc has filed for 1 generic for Buprenorphine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Somerset Theraps Llc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
EQ 0.3MG BASE/ML
injectable
Prescription
INJECTION
AP
Jan 30, 2025
13. 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
Billerica
Sun Pharmaceutical Industries, Inc.
Lexington
Sun Pharmaceutical Industries Inc
Princeton
SUN PHARMACEUTICAL INDUSTRIES INC
India
Malanpur, Bhind (District)
Sun Pharmaceutical Industries Limited
Baruch
Sun Pharmaceutical Industries Ltd.
Kanchipuram
Sun Pharmaceutical Industries Limited- Madhuranthagam
Dadra
Sun Pharmaceutical Industries Limited
Vadodara
Sun Pharmaceutical Industries Ltd
Bharuch
Sun Pharmaceutical Industries Ltd
Halol
Sun Pharmaceutical Industries Ltd.
Mohali
Sun Pharmaceutical Industries Limited
Vadodara
Sun Pharmaceutical Industries Limited - Karkhadi
Gurugram
Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
