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 Mylan Specialty Lp A Viatris Co
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 | 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 | US8071073 | Compositions comprising azelastine and methods of use thereof | Jun 04, 2028 | Bayer Hlthcare |
| 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 | US8071073 | Compositions comprising azelastine and methods of use thereof | Jun 04, 2028 | 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 |
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Azelastine Hydrochloride Generics
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.
1. 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 |
2. 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 |
3. 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 |
4. 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 |
5. 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 |
6. 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 |
7. 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 |
8. 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 |
9. SAPTALIS PHARMS
Saptalis Pharmaceuticals Llc has filed for 1 generic for Azelastine Hydrochloride. Given below are the details of the strengths of this generic introduced by Saptalis Pharms.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.2055MG/SPRAY | spray, metered | Discontinued | NASAL | N/A | Aug 23, 2019 |
10. 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 |
11. 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 |
12. 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 |
13. 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 |
14. 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 |
15. 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 |
16. 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 |
17. 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 |