AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE - Generic Drug Details

What are the generic drug sources for azelastine hydrochloride; fluticasone propionate and what is the scope of patent protection?

Azelastine hydrochloride; fluticasone propionate is the generic ingredient in two branded drugs marketed by Apotex, Padagis Israel, and Mylan Speciality Lp, and is included in three NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Azelastine hydrochloride; fluticasone propionate has fifty-seven patent family members in twenty-seven countries.

Five suppliers are listed for this compound.

Summary for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

International Patents:	57
US Patents:	2
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	5
Clinical Trials:	16
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
DailyMed Link:	AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE at DailyMed

Recent Clinical Trials for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Humanis Saglık Anonim Sirketi	Phase 1
Wuhan Union Hospital, China	Phase 4
Zheng Liu ENT	Phase 4

See all AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE clinical trials

Pharmacology for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Drug Class	Corticosteroid Histamine-1 Receptor Antagonist
Mechanism of Action	Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R06AX	Other antihistamines for systemic use
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DYMISTA	Nasal Spray	azelastine hydrochloride; fluticasone propionate	137 mcg/50 mcg per spray	202236	1	2014-06-13

US Patents and Regulatory Information for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No	8,168,620*PED				Y
Apotex	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	207712-001	Apr 28, 2017	AB	RX	No	Yes
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	AB	RX	Yes	No	8,163,723*PED
Padagis Israel	AZELASTINE HYDROCHLORIDE AND FLUTICASONE PROPIONATE	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	208111-001	Feb 18, 2021	AB	RX	No	No

Expired US Patents for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	8,163,723*PED
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	9,901,585
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	9,259,428*PED

International Patents for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Country	Patent Number	Title	Estimated Expiration
Slovenia	2072051
Portugal	2072051
Brazil	PI0312128	formulação farmacêutica compreendendo azelastina e éster de fluticasona
Australia	2009243420	Combination of azelastine and steroids

Supplementary Protection Certificates for AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1519731	PA2013023	Lithuania		PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
1519731	1390033-7	Sweden		PRODUCT NAME: AZELASTIN, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV, OCH EN FARMACEUTISKT GODTAGBAR ESTER AV FLUTIKASON; NAT. REG. NO/DATE: MTNR 47084 20130221; FIRST REG.: SK 24/0055/13-S 20130215
0316633	99C0012	Belgium		PRODUCT NAME: AZELASTINE HYDROCHLORIDE; NAT. REGISTRATION NO/DATE: 31 IS 113 F 13 19981021; FIRST REGISTRATION: GB PL 08336/0083 19980218

AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Azelastine Hydrochloride and Fluticasone Propionate

Introduction

Azelastine hydrochloride and fluticasone propionate, combined in a nasal spray, represent a significant treatment option for seasonal allergic rhinitis (SAR) and other allergic conditions. This article delves into the market dynamics and financial trajectory of this drug combination, highlighting key factors, trends, and analyses.

Market Size and Growth

The global market for azelastine hydrochloride and fluticasone propionate nasal sprays is projected to grow substantially over the forecast period from 2025 to 2031. According to market reports, the base year for calculations is 2023, with historical data from 2019 to 2023 and estimated data for 2024, followed by forecasted data up to 2031[1].

Key Factors Affecting the Market

Several factors influence the market dynamics of this drug combination:

Efficacy and Clinical Outcomes

Studies have shown that the combination of azelastine and fluticasone propionate significantly improves nasal and ocular symptoms in patients with SAR. This combination has been found to be more effective than either drug used alone, doubling the effect in reducing symptom scores[2].

Regulatory Approvals

The drug was first approved in 2012 for adults and adolescents 12 years and older, and later in 2015 for children aged 6 to 11 years. These approvals have expanded the target market and contributed to the drug's growing demand[4].

Pharmacoeconomic Analysis

Cost-utility analyses have been conducted to evaluate the incremental cost-effectiveness of azelastine hydrochloride and fluticasone propionate compared to other treatments. While the drug is more expensive, it offers significant improvements in quality-adjusted life years (QALYs), making it a valuable option for healthcare payers despite its higher cost[3].

Regional Analysis

The market for azelastine hydrochloride and fluticasone propionate is expected to be dominated by regions with high prevalence rates of allergic rhinitis. North America and Europe are anticipated to be key markets due to their well-established healthcare systems and high demand for effective allergy treatments[1].

Segment Analysis

The market can be segmented by type, age group, and region. The adult segment is currently the largest, but the pediatric segment is growing rapidly following the expansion of the drug's indication to include children aged 6 to 11 years[4].

Market Trends

Increasing Prevalence of Allergic Rhinitis

The rising prevalence of allergic rhinitis globally is a significant driver for the market. As more people seek effective treatments, the demand for azelastine hydrochloride and fluticasone propionate nasal sprays is expected to increase.

Advancements in Healthcare

Improvements in healthcare infrastructure and increased access to medications in developing countries are also driving market growth.

Generic and Biosimilar Competition

While the original formulation is still under patent, the potential entry of generic or biosimilar versions could impact market dynamics and pricing strategies in the future.

Financial Trajectory

Revenue and CAGR

The revenue from azelastine hydrochloride and fluticasone propionate nasal sprays is expected to grow at a significant compound annual growth rate (CAGR) over the forecast period. The exact CAGR can vary depending on market conditions and competition[1].

Cost-Effectiveness

Despite the higher cost of the combination therapy, pharmacoeconomic analyses suggest that it offers good value in terms of QALYs. For instance, the incremental cost-effectiveness ratio (ICUR) of azelastine hydrochloride and fluticasone propionate compared to fluticasone propionate alone was found to be $194,592 per QALY, which could be reduced with price adjustments[3].

Pricing Strategies

The pricing of the drug is a critical factor in its financial trajectory. Manufacturers may need to consider price reductions to make the drug more competitive, especially if generic or biosimilar versions enter the market. A price reduction of 55% could significantly reduce the ICUR, making the drug more attractive to healthcare payers[3].

Competitive Analysis

The market for azelastine hydrochloride and fluticasone propionate is competitive, with other antihistamines and corticosteroids available. However, the combination of these two drugs in a single formulation provides a unique selling point, enhancing its market position.

ESG and PESTEL Analysis

Environmental, Social, and Governance (ESG) Factors

The production and distribution of azelastine hydrochloride and fluticasone propionate must comply with environmental regulations and social responsibility standards. Companies that prioritize ESG factors may gain a competitive edge.

Political, Economic, Social, Technological, Environmental, and Legal (PESTEL) Factors

PESTEL analysis highlights the impact of various external factors on the market. For example, changes in healthcare policies, economic conditions, and technological advancements can influence the market's growth and profitability[1].

Technological Trends

Advancements in drug delivery systems and the development of new formulations could impact the market. However, the current formulation of azelastine hydrochloride and fluticasone propionate remains a gold standard for SAR treatment.

SWOT Analysis

Strengths

• High efficacy in reducing nasal and ocular symptoms.
• Wide age range of approved use.
• Strong regulatory approvals.

Weaknesses

• Higher cost compared to monotherapies.
• Potential side effects such as adrenal suppression with chronic use.

Opportunities

• Expanding market due to increasing prevalence of allergic rhinitis.
• Potential for use in other allergic conditions.

Threats

• Entry of generic or biosimilar versions.
• Regulatory changes affecting pricing and reimbursement.

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the market. While it has disrupted supply chains and affected healthcare resources, it has also highlighted the importance of effective treatments for respiratory conditions, potentially increasing demand for azelastine hydrochloride and fluticasone propionate[1].

Consumer Behavior Analysis

Consumer behavior plays a crucial role in the market dynamics. Patients seeking effective and convenient treatments for allergic rhinitis are driving the demand for this combination therapy. The improvement in quality of life, as measured by QALYs, is a significant factor influencing consumer preference[3].

Key Takeaways

• The market for azelastine hydrochloride and fluticasone propionate nasal sprays is expected to grow significantly due to its high efficacy and expanding indications.
• The drug's financial trajectory is influenced by its cost-effectiveness, pricing strategies, and competitive landscape.
• Regulatory approvals, pharmacoeconomic analyses, and consumer behavior are key drivers of market dynamics.
• The potential entry of generic or biosimilar versions could impact the market in the future.

FAQs

What is the recommended dosage of azelastine hydrochloride and fluticasone propionate nasal spray?

The recommended dose is 1 spray (137 mcg/50 mcg) per nostril twice daily (total 548 mcg/200 mcg daily)[4].

What are the key benefits of using azelastine hydrochloride and fluticasone propionate together?

The combination significantly improves nasal and ocular symptoms in patients with SAR, offering better efficacy than either drug used alone[2].

How has the COVID-19 pandemic affected the market for azelastine hydrochloride and fluticasone propionate?

The pandemic has had a mixed impact, disrupting supply chains but also highlighting the importance of effective treatments for respiratory conditions, potentially increasing demand[1].

What are the potential side effects of long-term use of azelastine hydrochloride and fluticasone propionate?

Long-term use can lead to systemic corticosteroid effects such as hypercorticism and adrenal suppression, especially with excessive doses or in conjunction with other corticosteroids[5].

Is azelastine hydrochloride and fluticasone propionate approved for use in children?

Yes, it is approved for children aged 6 to 11 years, with ongoing studies evaluating its safety and efficacy in younger children[4].

Sources

1. Cognitivemarketresearch.com: Azelastine Fluticasone Nasal Market Report 2024 (Global Edition)
2. Tga.gov.au: Product Information for fluticasone propionate and azelastine
3. Cda-amc.ca: CDR Pharmacoeconomic Review Report for Dymista
4. Fda.gov: Dymista (azelastine hydrochloride fluticasone propionate) Safety
5. Pdf.hres.ca: Azelastine Hydrochloride and Fluticasone Propionate Suspension Nasal Spray