SYMBICORT AEROSPHERE Drug Patent Profile

When do Symbicort Aerosphere patents expire, and when can generic versions of Symbicort Aerosphere launch?

Symbicort Aerosphere is a drug marketed by Astrazeneca and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and ninety-two patent family members in thirty-two countries.

The generic ingredient in SYMBICORT AEROSPHERE is budesonide; formoterol fumarate. There are twenty-two drug master file entries for this compound. Additional details are available on the budesonide; formoterol fumarate profile page.

DrugPatentWatch^® Generic Entry Outlook for Symbicort Aerosphere

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 28, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for SYMBICORT AEROSPHERE

International Patents:	192
US Patents:	2
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMBICORT AEROSPHERE
DailyMed Link:	SYMBICORT AEROSPHERE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SYMBICORT AEROSPHERE

NDA:

216579

Dosage:

AEROSOL, METERED;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for SYMBICORT AEROSPHERE

SYMBICORT AEROSPHERE is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	SYMBICORT AEROSPHERE	budesonide; formoterol fumarate	AEROSOL, METERED;INHALATION	216579-001	Apr 28, 2023		RX	Yes	Yes			Y
Astrazeneca	SYMBICORT AEROSPHERE	budesonide; formoterol fumarate	AEROSOL, METERED;INHALATION	216579-001	Apr 28, 2023		RX	Yes	Yes

International Patents for SYMBICORT AEROSPHERE

When does loss-of-exclusivity occur for SYMBICORT AEROSPHERE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

France

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Mexico

Montenegro

Netherlands

Norway

Philippines

Poland

Portugal

Russian Federation

San Marino

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SYMBICORT AEROSPHERE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2018008942	活性剤を呼吸器送達するための組成物、ならびに関連する方法および系 (COMPOSITION FOR RESPIRATORY DELIVERY OF ACTIVE AGENT, AND RELATED METHOD AND SYSTEM)
Japan	2012528792
Brazil	PI1011220
South Korea	20190049943	활성제의 호흡기 전달 (RESPIRATORY DELIVERY OF ACTIVE AGENTS)
South Korea	101748892

Supplementary Protection Certificates for SYMBICORT AEROSPHERE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	C202130025	Spain		PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209
2435025	2019C/532	Belgium		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435025	C201930043	Spain		PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 20181218
2435025	CA 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
2435024	PA2021511	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209

Market Dynamics and Financial Trajectory for SYMBICORT AEROSPHERE

Last updated: July 27, 2025

---

Introduction

SYMBICORT AEROSPHERE is a leading inhalation therapy used for the management of asthma and chronic obstructive pulmonary disease (COPD). Developed through a collaboration between AstraZeneca and Merck, its unique combination of budesonide and formoterol offers rapid relief and sustained bronchoprotection. Given the global respiratory disease burden, understanding the market dynamics and financial trajectory of SYMBICORT AEROSPHERE provides strategic insights for pharmaceutical stakeholders, investors, and healthcare providers.

---

Global Market Overview

The respiratory inhaler market anticipates robust growth driven by rising incidence of asthma and COPD, especially in emerging markets. According to IQVIA, the global respiratory drugs market was valued at approximately $31 billion in 2022, with a compound annual growth rate (CAGR) of ~4.2% projected through 2027.[1] SYMBICORT, a corticosteroid-beta-agonist combination, holds a significant share owing to its proven efficacy and convenience.

The U.S. remains the largest market, primarily due to high prevalence rates and established healthcare infrastructure. However, emerging economies, such as China, India, and Brazil, are experiencing accelerated growth due to increasing disease awareness, urbanization, and expanding healthcare access.

---

Market Drivers

1. Rising Prevalence of Respiratory Conditions:
World-wide, asthma affects over 300 million individuals, while COPD prevalence surpasses 200 million, with projections indicating a rising trend due to aging populations and environmental factors. This expanding patient base bolsters demand for effective inhalation therapies like SYMBICORT.[2]

2. Patient Preference for Combination Inhalers:
Combination inhalers improve compliance by reducing medication burden. SYMBICORT’s fixed-dose combination streamlines therapy, aligning with the shift toward simplified treatment regimens.

3. Advancements in Inhaler Technologies:
Improved aerosol delivery methods, such as the AerSphere device—designed for optimal drug deposition—enhance efficacy and patient adherence, thus supporting sales growth.

4. Regulatory Approvals and Label Expansion:
Regulatory bodies like FDA and EMA continually endorse the safety and efficacy of SYMBICORT, including approval for specific age groups. These approvals expand market access.

---

Market Challenges

1. Competition from Other Inhaler Products:
Markets feature numerous competitors, including Fluticasone/Salmeterol (Advair), Budesonide/Formoterol (Symbicort, the same formulation but with different delivery devices), and mono-components, which challenge SYMBICORT's market share.

2. Patent Expiry and Generic Entry:
Patents for key formulations have begun to expire around mid-2020s, opening avenues for generic competitors that could erode revenue streams.

3. Pricing Pressures and Reimbursement Dynamics:
Budget constraints and policy shifts favoring generics exert downward pressure on inhaler pricing and reimbursement rates, influencing profit margins.

---

Financial Trajectory

1. Revenue Trends:
AstraZeneca’s respiratory portfolio, including SYMBICORT, has shown steady revenue growth over recent years. In 2022, SYMBICORT's global sales exceeded $2.5 billion, representing a CAGR of approximately 3% over the previous five years.[3] This growth is attributable to increased adoption in emerging markets and new regulatory approvals.

2. Impact of Patent Expiration:
The upcoming patent expirations threaten market exclusivity, with analysts estimating a potential 10-15% decline in sales within 2-3 years absent strategic adaptations.

3. Portfolio Diversification and Pipeline:
AstraZeneca plans to offset potential declines by expanding its pipeline with next-generation inhalers and biologic treatments for severe respiratory diseases. These investments aim to sustain long-term revenue streams.

4. Pricing Strategies:
AstraZeneca employs tiered pricing and differential co-payments across regions to maintain market penetration while managing reimbursement negotiations.

5. Market Penetration Strategies:
Intensive marketing, clinician education, and patient assistance programs foster adoption, especially in under-penetrated markets.

---

Future Outlook

1. Market Expansion Opportunities:
Strategic focus on emerging markets and greater utilization in pediatric and COPD populations suggest continued growth. Additionally, the introduction of biosimilar and generic versions will influence the competitive landscape.

2. Innovating Delivery Devices:
Recent advances in aerosolization technology, such as AerSphere, enhance drug delivery efficiency, potentially providing a competitive edge and supporting sales.

3. Regulatory and Policy Landscape:
Evolving regulatory standards for inhaler devices and environmental concerns regarding inhaler propellants (e.g., HFA vs. HFC) will shape product development strategies.

4. Potential for Portfolio Synergies:
Combining SYMBICORT with digital health platforms and adherence monitoring tools could improve treatment outcomes and drive sales.

---

Conclusion

The financial and market trajectory of SYMBICORT AEROSPHERE hinges on strategic positioning amidst a competitive and evolving landscape. While current growth remains robust, patent expirations and market commoditization threaten future revenue streams. Companies that innovate delivery technology, expand into new markets, and diversify their respiratory portfolios will likely sustain growth. Heightened focus on regulatory compliance, affordability, and patient engagement remains essential to capitalizing on the global respiratory disease burden.

---

Key Takeaways

• Robust Growth Amid Market Expansion: SYMBICORT benefits from rising respiratory disease prevalence and patient preferences favoring combination inhalers.

• Intense Competition and Patent Risks: Expiring patents and the rise of generics present significant challenges, necessitating innovation and strategic market expansion.

• Focus on Emerging Markets: Rapid growth in Asia and Latin America offers substantial opportunity but requires tailored access strategies.

• Innovative Delivery Devices Enhance Value: Devices like AerSphere bolster drug efficacy and patient adherence, supporting sustainable sales.

• Long-Term Viability Requires Diversification: Pipeline development and digital health integration are key to maintaining revenue momentum.

---

FAQs

1. How does SYMBICORT AEROSPHERE differ from other inhalers in the market?
SYMBICORT employs the AerSphere device, designed for superior aerosol delivery, which enhances drug deposition in the lungs and improves patient adherence compared to traditional inhalers.

2. What are the main factors impacting SYMBICORT’s future sales?
Patent expirations, competition from generics, regulatory changes, market penetration in emerging regions, and ongoing innovation in inhaler technology will influence future sales.

3. How are regulatory developments affecting SYMBICORT?
Regulatory approvals expand market access, while evolving standards for inhaler devices demand ongoing compliance and technological innovation.

4. What strategies are pharmaceutical companies adopting to sustain SYMBICORT’s market share?
Strategies include device innovation, market expansion, strategic pricing, patient engagement programs, and pipeline diversification.

5. What is the outlook for the global respiratory market, and how does SYMBICORT fit in?
The market is projected to grow at over 4% CAGR, driven by increasing prevalence and technological advances. SYMBICORT remains a significant player due to its clinical efficacy and device technology, though it faces homogenous competition.

---

References

[1] IQVIA, Global Respiratory Market Data Report, 2022.

[2] World Health Organization, Respiratory Disease Statistics, 2022.

[3] AstraZeneca Annual Report, 2022.