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Azelastine Hydrochloride Patent Expiration

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 Allergy, Children'S Astepro Allergy, Astepro, Optivar. 21 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.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Astepro US8071073 Compositions comprising azelastine and methods of use thereof Jun 04, 2028 Meda Pharms
Astepro US8071073 Compositions comprising azelastine and methods of use thereof Jun 04, 2028 Norvium Bioscience
Astepro Allergy US8071073 Compositions comprising azelastine and methods of use thereof Jun 04, 2028 Bayer Hlthcare
Children's Astepro Allergy US8071073 Compositions comprising azelastine and methods of use thereof Jun 04, 2028 Bayer Hlthcare
Astepro US8518919 Compositions comprising azelastine and methods of use thereof Nov 22, 2025 Meda Pharms
Astepro US8518919 Compositions comprising azelastine and methods of use thereof Nov 22, 2025 Norvium Bioscience
Astepro US9919050 Compositions comprising azelastine Nov 22, 2025 Norvium Bioscience
Astepro Allergy US8518919 Compositions comprising azelastine and methods of use thereof Nov 22, 2025 Bayer Hlthcare
Astepro Allergy US9919050 Compositions comprising azelastine Nov 22, 2025 Bayer Hlthcare
Children's Astepro Allergy US8518919 Compositions comprising azelastine and methods of use thereof Nov 22, 2025 Bayer Hlthcare
Children's Astepro Allergy US9919050 Compositions comprising azelastine Nov 22, 2025 Bayer Hlthcare



Azelastine Hydrochloride's Family Patents

Family Patents

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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.

Country City Firm Name
India
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited





2. ALKEM LABS LTD

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
Paterson Amneal Pharmaceuticals, Llc
East Hanover Amneal Pharmaceuticals LLC
Branchburg Amneal Pharmaceuticals, LLC
Piscataway Amneal Pharmaceuticals, LLC
Bridgewater Amneal Complex Products Research LLC
Brookhaven Amneal Pharmaceuticals of New York, LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
India
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Matoda Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited





4. APOTEX

Apotex Inc 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 Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
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
Winnipeg Apotex Fermentation Inc.
Toronto Apotex Inc.
Richmond Hill Apotex Inc.
Etobicoke Apotex, Inc.
North York Apotex Inc.
Brantford Apotex Pharmachem Inc.
India
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.





5. APOTEX INC

Apotex Inc has filed for 3 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
0.05%

solution/drops Prescription OPHTHALMIC AT Aug 3, 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.
North York Apotex Inc.
Richmond Hill 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
Sangareddy Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
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
Visakhapatnam Gland Pharma Limited
Sriperumbudur Gland Chemical Private Limited
Parawada, Visakhapatnam Gland Pharma Limited
Hyderabad Gland Pharma Limited, Units I+II Pashamylaram Site
Hyderabad Gland Pharma Limited
Aurangabad Gland Chemical Private Limited
Malur Gland Chemicals Pvt Ltd.





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
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Eatontown Hikma Pharmaceuticals USA, Inc.
Dayton Hikma Injectables USA Inc
Cherry Hill Hikma Pharmaceuticals USA Inc.
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
Kundl Sandoz GmbH
Langkampfen 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.
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Lexington Sun Pharmaceutical Industries Inc
India
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Mohali Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Ltd
Halol Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Ltd.
New Delhi Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.
Punjab Sun Pharmaceutical Industries, Inc.
Ahmednagar Sun Pharmaceutical Industries Limited
Dadra Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)





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.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.137MG/SPRAY

spray, metered Prescription NASAL AB Aug 14, 2017