Azelastine Hydrochloride is Used for relieving allergy symptoms such as nasal congestion, runny nose, sneezing, and itchy nose. It was first introduced by Norvium Bioscience Llc in its drug Astelin on Nov 1, 1996. Other drugs containing Azelastine Hydrochloride are Astepro, Optivar, Children'S Astepro Allergy, Astepro Allergy. 22 different companies have introduced drugs containing Azelastine Hydrochloride.
Azelastine Hydrochloride Patents
Given below is the list of patents protecting Azelastine Hydrochloride, along
with the drug name that holds that patent and the company name owning that
drug.
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Azelastine Hydrochloride Generic API Manufacturers
Several generic applications have been filed for Azelastine Hydrochloride. The first generic version for Azelastine Hydrochloride was by Apotex Inc and was approved on Apr 30, 2009. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Jan 27, 2025.
Given below is the list of companies who have filed for
Azelastine Hydrochloride generic, along with the locations of their manufacturing plants worldwide.
1. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 1 generic for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Alembic.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.05%
solution/drops
Prescription
OPHTHALMIC
AT
Mar 20, 2019
Manufacturing Plant Locations
New
Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.
Alkem Laboratories Ltd has filed for 1 generic for Azelastine 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
0.137MG/SPRAY
spray, metered
Prescription
NASAL
AB
Aug 18, 2017
3. AMNEAL
Amneal Pharmaceuticals Llc has filed for 2 different strengths of generic version for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Amneal.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.137MG/SPRAY
spray, metered
Prescription
NASAL
AB
Aug 28, 2017
0.2055MG/SPRAY
spray, metered
Over the counter
NASAL
N/A
Jun 5, 2024
Manufacturing Plant Locations
New
Amneal'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 Amneal as present at those locations.
Country
City
Firm Name
United States
Hauppauge
Amneal Pharmaceuticals of New York, LLC
Piscataway
Amneal Pharmaceuticals, LLC
Brookhaven
Amneal Pharmaceuticals of New York, LLC
Glasgow
Amneal Pharmaceuticals LLC
Bridgewater
Amneal Complex Products Research LLC
Paterson
Amneal Pharmaceuticals, Llc
East Hanover
Amneal Pharmaceuticals LLC
Branchburg
Amneal Pharmaceuticals, LLC
India
Tal Bavla, Ahmedabad
Amneal Pharmaceuticals Pvt. Ltd.
Hyderabad
Amneal Oncology Private Limited
Ahmedabad
Amneal Pharmaceuticals Private Ltd.
Matoda
Amneal Pharmaceuticals Private Ltd.
4. APOTEX
Apotex Inc has filed for 2 different strengths of generic version for Azelastine Hydrochloride. Out of these 0.2055mg/spray version comes by the name AZELASTINE HYDROCHLORIDE ALLERGY. Given below are the
details of the strengths of this generic introduced by
Apotex.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.05%
solution/drops
Prescription
OPHTHALMIC
AT
Aug 3, 2009
0.2055MG/SPRAY
spray, metered
Over the counter
NASAL
N/A
May 29, 2024
Manufacturing Plant Locations
New
Apotex'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 Apotex as present at those locations.
Country
City
Firm Name
United States
Weston
Apotex Corp.
Canada
Toronto
Apotex Inc.
Winnipeg
Apotex Fermentation Inc.
Etobicoke
Apotex, Inc.
Richmond Hill
Apotex Inc.
North York
Apotex Inc.
Brantford
Apotex Pharmachem Inc.
India
Bangalore
Apotex Research Private Limited - Bioequivalence Centre
Bangalore
Apotex Pharmachem India Pvt Ltd.
Bengaluru
Apotex Research Private Limited
5. APOTEX INC
Apotex Inc has filed for 2 different strengths of generic version for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Apotex Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.137MG/SPRAY
(reference standard)
spray, metered
Prescription
NASAL
AB
Apr 30, 2009
0.2055MG/SPRAY
spray, metered
Discontinued
NASAL
N/A
Aug 31, 2012
Manufacturing Plant Locations
New
Apotex Inc's manufacturing plants are situated in 1 country - Canada. Given below are the details of these plant locations as well as the firm names of Apotex Inc as present at those locations.
Country
City
Firm Name
Canada
Toronto
Apotex Inc.
Richmond Hill
Apotex Inc.
North York
Apotex Inc.
6. AUROBINDO PHARMA
Aurobindo Pharma Ltd has filed for 1 generic for Azelastine Hydrochloride. This 0.2055mg/spray version comes by the name AZELASTINE HYDROCHLORIDE ALLERGY. Given below are the
details of the strengths of this generic introduced by
Aurobindo Pharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.2055MG/SPRAY
spray, metered
Over the counter
NASAL
N/A
Jan 27, 2025
Manufacturing Plant Locations
New
Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.
Country
City
Firm Name
India
Polepally, Mahaboob Nagar
Aurobindo Pharma Limited
Sangareddy
Aurobindo Pharma Limited
Bachupally
Aurobindo Pharma Limited
Medchal
Aurobindo Pharma Ltd
United States
East Windsor
Aurobindo Pharma USA Inc
7. AUROBINDO PHARMA LTD
Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Aurobindo Pharma Ltd.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.137MG/SPRAY
spray, metered
Prescription
NASAL
AB
May 8, 2020
0.2055MG/SPRAY
spray, metered
Discontinued
NASAL
N/A
Nov 12, 2020
Manufacturing Plant Locations
New
Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.
Country
City
Firm Name
India
Medchal
Aurobindo Pharma Ltd
8. BIONPHARMA
Bionpharma Inc has filed for 1 generic for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Bionpharma.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.137MG/SPRAY
spray, metered
Discontinued
NASAL
N/A
Jul 28, 2015
Manufacturing Plant Locations
New
Bionpharma'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 Bionpharma as present at those locations.
Country
City
Firm Name
United States
Princeton
Bionpharma Inc.
9. EPIC PHARMA LLC
Epic Pharma Llc has filed for 2 different strengths of generic version for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Epic Pharma Llc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.05%
solution/drops
Discontinued
OPHTHALMIC
N/A
Nov 8, 2016
0.137MG/SPRAY
spray, metered
Prescription
NASAL
AB
May 17, 2019
10. GLAND
Gland Pharma Ltd has filed for 1 generic for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Gland.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.05%
solution/drops
Prescription
OPHTHALMIC
AT
Feb 25, 2020
Manufacturing Plant Locations
New
Gland's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Gland as present at those locations.
Country
City
Firm Name
India
Parawada, Visakhapatnam
Gland Pharma Limited
Visakhapatnam
Gland Pharma Limited
Hyderabad
Gland Pharma Limited, Units I+II Pashamylaram Site
Malur
Gland Chemicals Pvt Ltd.
Aurangabad
Gland Chemical Private Limited
Sriperumbudur
Gland Chemical Private Limited
Hyderabad
Gland Pharma Limited
11. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Azelastine 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
0.137MG/SPRAY
spray, metered
Discontinued
NASAL
N/A
Oct 24, 2014
0.2055MG/SPRAY
spray, metered
Discontinued
NASAL
N/A
Sep 22, 2017
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
Dayton
Hikma Injectables USA Inc
Eatontown
Hikma Pharmaceuticals USA, Inc.
Cherry Hill
Hikma Pharmaceuticals USA Inc.
Carlsbad
Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt
Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman
Hikma Pharmaceuticals LLC
12. PADAGIS ISRAEL
Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Padagis Israel.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.2055MG/SPRAY
spray, metered
Discontinued
NASAL
N/A
May 8, 2024
Manufacturing Plant Locations
New
Padagis Israel's manufacturing plants are situated in 1 country - Israel. Given below are the details of these plant locations as well as the firm names of Padagis Israel as present at those locations.
Country
City
Firm Name
Israel
Yerucham
Padagis Israel Pharmaceuticals Ltd.
13. SANDOZ
Sandoz Inc has filed for 1 generic for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Sandoz.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.05%
(reference standard)
solution/drops
Prescription
OPHTHALMIC
AT
May 31, 2012
Manufacturing Plant Locations
New
Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.
Country
City
Firm Name
Austria
Langkampfen
Sandoz GmbH
Kundl
Sandoz GmbH
United States
East Hanover
Sandoz Incorporated
Princeton
Sandoz Inc
Spain
Palafolls
Sandoz Industrial Products, S.A.
Les Franqueses Del Valles
Sandoz Industrial Products S.A.
India
Navi Mumbai
Sandoz Private Limited
14. SCIEGEN PHARMS INC
Sciegen Pharmaceuticals Inc has filed for 1 generic for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Sciegen Pharms Inc.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.2055MG/SPRAY
spray, metered
Discontinued
NASAL
N/A
Aug 23, 2019
15. SOMERSET THERAPS LLC
Somerset Therapeutics Llc has filed for 1 generic for Azelastine 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
0.05%
solution/drops
Prescription
OPHTHALMIC
AT
Mar 29, 2019
16. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Azelastine 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
0.05%
solution/drops
Discontinued
OPHTHALMIC
N/A
Jun 21, 2010
0.137MG/SPRAY
spray, metered
Discontinued
NASAL
N/A
May 23, 2012
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
Vadodara
Sun Pharmaceutical Industries Ltd
Vadodara
Sun Pharmaceutical Industries Ltd.
Bharuch
Sun Pharmaceutical Industries Ltd
Gurugram
Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Punjab
Sun Pharmaceutical Industries, Inc.
Dadra
Sun Pharmaceutical Industries Limited
Kanchipuram
Sun Pharmaceutical Industries Limited- Madhuranthagam
Mohali
Sun Pharmaceutical Industries Limited
Halol
Sun Pharmaceutical Industries Ltd.
Vadodara
Sun Pharmaceutical Industries Limited - Karkhadi
New Delhi
Sun Pharmaceutical Industries Limited
Ahmednagar
Sun Pharmaceutical Industries Limited
Baruch
Sun Pharmaceutical Industries Ltd.
17. UPSHER SMITH LABS
Upsher Smith Laboratories Llc has filed for 1 generic for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Upsher Smith Labs.
Strength
Dosage Form
Availability
Application Pathway
TE code
Launch Date
0.137MG/SPRAY
spray, metered
Prescription
NASAL
AB
Mar 17, 2017
18. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 1 generic for Azelastine Hydrochloride. Given below are the
details of the strengths of this generic introduced by
Zydus Pharms.
