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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, Astepro Allergy, Children'S Astepro Allergy, 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 Mylan Speciality Lp
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 Mylan Speciality Lp
Astepro US9919050 Compositions comprising azelastine Nov 22, 2025 Mylan Speciality Lp
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 Amneal Pharmaceuticals Llc and was approved on Jun 5, 2024.

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
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd
Vadodara Alembic Pharmaceuticals, Ltd
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals Limited
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
Brookhaven Amneal Pharmaceuticals of New York, LLC
East Hanover Amneal Pharmaceuticals LLC
Paterson Amneal Pharmaceuticals, Llc
Branchburg Amneal Pharmaceuticals, LLC
Bridgewater Amneal Complex Products Research LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Glasgow Amneal Pharmaceuticals LLC
Piscataway Amneal Pharmaceuticals, LLC
India
Matoda Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad Amneal Pharmaceuticals Private Ltd.





4. APOTEX

Apotex Inc has filed for 1 generic for Azelastine Hydrochloride. This 0.2055mg/spray version comes by the name AZELASTINE HYDROCHLORIDE CHILDREN'S 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
North York Apotex Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
Brantford Apotex Pharmachem Inc.
Toronto Apotex Inc.
Richmond Hill Apotex Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bengaluru Apotex Research Private Limited
Bangalore Apotex Research Private Limited - Bioequivalence Centre





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 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





7. 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 Prescription NASAL AB 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.





8. 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





9. GLAND PHARMA LTD

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 Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.05%

solution/drops Prescription OPHTHALMIC AT Feb 25, 2020





10. 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
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Cherry Hill Hikma Pharmaceuticals USA Inc.
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





11. 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.





12. 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





13. 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





14. 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





15. 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 Prescription OPHTHALMIC AT Jun 21, 2010
0.137MG/SPRAY

spray, metered Prescription NASAL AB 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
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Punjab Sun Pharmaceutical Industries, Inc.
Vadodara Sun Pharmaceutical Industries Ltd.
Halol Sun Pharmaceutical Industries Ltd.
Dadra Sun Pharmaceutical Industries Limited
Bharuch Sun Pharmaceutical Industries Ltd
Baruch Sun Pharmaceutical Industries Ltd.
Ahmednagar Sun Pharmaceutical Industries Limited
Mohali Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
New Delhi Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd





16. 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





17. 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