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 in its drug Dymista on May 1, 2012. 3 different companies have introduced drugs containing Azelastine Hydrochloride; Fluticasone Propionate.


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

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 Padagis Israel Pharmaceuticals Ltd and was approved on Feb 18, 2021.

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
Weston Apotex Corp.
Canada
Brantford Apotex Pharmachem Inc.
Richmond Hill Apotex Inc.
North York Apotex Inc.
Toronto Apotex Inc.
Etobicoke Apotex, Inc.
Winnipeg Apotex Fermentation Inc.
India
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre





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
Yerucham Padagis Israel Pharmaceuticals Ltd.