Azelastine Hydrochloride; Fluticasone Propionate Patent Expiration
Azelastine Hydrochloride; Fluticasone Propionate is Used for relieving symptoms of seasonal allergic rhinitis. It was first introduced by Mylan Specialty Lp
Azelastine Hydrochloride; Fluticasone Propionate Patents
Given below is the list of patents protecting Azelastine Hydrochloride; Fluticasone Propionate, 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 |
|---|---|---|---|---|
| Dymista |
US8168620 (Pediatric) | Combination of azelastine and steroids | Aug 24, 2026 | Mylan Speciality Lp |
| Dymista | US8168620 | Combination of azelastine and steroids | Feb 24, 2026 | Mylan Speciality Lp |
| Dymista |
US8163723 (Pediatric) | Combination of azelastine and steroids |
Feb 29, 2024
(Expired) | Mylan Speciality Lp |
| Dymista |
US9259428 (Pediatric) | Combination of azelastine and fluticasone for nasal administration |
Dec 13, 2023
(Expired) | Mylan Speciality Lp |
| Dymista | US8163723 | Combination of azelastine and steroids |
Aug 29, 2023
(Expired) | Mylan Speciality Lp |
| Dymista | US9259428 | Combination of azelastine and fluticasone for nasal administration |
Jun 13, 2023
(Expired) | Mylan Speciality Lp |
| Dymista | US9901585 | Combination of azelastine and fluticasone for nasal administration |
Jun 13, 2023
(Expired) | Mylan Speciality Lp |
Azelastine Hydrochloride; Fluticasone Propionate's Family Patents
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Azelastine Hydrochloride; Fluticasone Propionate Generic API Manufacturers
Several generic applications have been filed for Azelastine Hydrochloride; Fluticasone Propionate. The first generic version for Azelastine Hydrochloride; Fluticasone Propionate was by Apotex Inc and was approved on Apr 28, 2017. And the latest generic version is by Teva Pharmaceuticals Usa Inc and was approved on Apr 8, 2025.
Given below is the list of companies who have filed for Azelastine Hydrochloride; Fluticasone Propionate generic, along with the locations of their manufacturing plants worldwide.
1. APOTEX
Apotex Inc has filed for 1 generic for Azelastine Hydrochloride; Fluticasone Propionate. This 0.137mg/spray;0.05mg/spray version comes by the name AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE. Given below are the details of the strengths of this generic introduced by Apotex.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.137MG/SPRAY; 0.05MG/SPRAY
(reference standard) | spray, metered | Prescription | NASAL | AB | Apr 28, 2017 |
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 |
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| Canada |
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| India |
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2. PADAGIS ISRAEL
Padagis Israel Pharmaceuticals Ltd has filed for 1 generic for Azelastine Hydrochloride; Fluticasone Propionate. This 0.137mg/spray;0.05mg/spray version comes by the name AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE. 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 |
|---|---|---|---|---|---|
| 0.137MG/SPRAY; 0.05MG/SPRAY | spray, metered | Prescription | NASAL | AB | Feb 18, 2021 |
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 |
| |||
3. TEVA PHARMS USA INC
Teva Pharmaceuticals Usa Inc has filed for 1 generic for Azelastine Hydrochloride; Fluticasone Propionate. This 0.137mg/spray;0.05mg/spray version comes by the name AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 0.137MG/SPRAY; 0.05MG/SPRAY | spray, metered | Prescription | NASAL | AB | Apr 8, 2025 |