SYMBICORT Drug Patent Profile

When do Symbicort patents expire, and what generic alternatives are available?

Symbicort is a drug marketed by Astrazeneca and is included in two NDAs. There are two patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in SYMBICORT 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

Annual sales in 2022 were $3.6bn, indicating a strong incentive for generic entry (peak sales were $5.7bn in 2019).

There have been fifteen patent litigation cases 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

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Clinical Trials:	146
Drug Prices:	Drug price information for SYMBICORT
Drug Sales Revenues:	Drug sales revenues for SYMBICORT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SYMBICORT
What excipients (inactive ingredients) are in SYMBICORT?	SYMBICORT excipients list
DailyMed Link:	SYMBICORT at DailyMed

See drug prices for SYMBICORT

See drug sales revenues for SYMBICORT

Recent Clinical Trials for SYMBICORT

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

Sponsor	Phase
AstraZeneca	PHASE4
Morten Hostrup, PhD	N/A
University of Alberta	Phase 1

See all SYMBICORT clinical trials

Pharmacology for SYMBICORT

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Paragraph IV (Patent) Challenges for SYMBICORT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMBICORT	Metered Inhalation	budesonide; formoterol fumarate dihydrate	80 mcg/4.5 mcg per inhalation and 160 mcg/4.5 mcg per inhalation	021929	1	2018-06-26

US Patents and Regulatory Information for SYMBICORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	AB	RX	Yes	Yes
Astrazeneca	SYMBICORT AEROSPHERE	budesonide; formoterol fumarate	AEROSOL, METERED;INHALATION	216579-001	Apr 28, 2023		RX	Yes	Yes	9,415,009
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	AB	RX	Yes	Yes
Astrazeneca	SYMBICORT AEROSPHERE	budesonide; formoterol fumarate	AEROSOL, METERED;INHALATION	216579-001	Apr 28, 2023		RX	Yes	Yes	10,716,753		Y

Expired US Patents for SYMBICORT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	7,897,646*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	7,367,333*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	7,759,328*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	8,143,239*PED

EU/EMA Drug Approvals for SYMBICORT

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Teva Pharma B.V.	Budesonide/Formoterol Teva Pharma B.V.	budesonide, formoterol fumarate dihydrate	EMEA/H/C/004882Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate:-in patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.or-in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.COPDSymptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1)	Authorised	no	no	no	2020-04-03
Teva Pharma B.V.	Budesonide/Formoterol Teva Pharma B.V.	budesonide, formoterol fumarate dihydrate	EMEA/H/C/003953Budesonide/Formoterol Teva Pharma B.V. is indicated in adults 18 years of age and older only.AsthmaBudesonide/Formoterol Teva Pharma B.V. is indicated in the regular treatment of asthma, where use of a combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate: orin patients not adequately controlled with inhaled corticosteroids and “as needed” inhaled short-acting β2 adrenoceptor agonists.in patients already adequately controlled on both inhaled corticosteroids and long-acting β2 adrenoceptor agonists.	Withdrawn	no	no	no	2014-11-19

International Patents for SYMBICORT

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

Country	Patent Number	Title	Estimated Expiration
China	1271287
Denmark	200700256
Taiwan	200526283	Inhaler cap strap
Iceland	2703

Supplementary Protection Certificates for SYMBICORT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
0613371	SPC016/2002	Ireland		SPC016/2002: 20041105, EXPIRES: 20150824
0613371	CA 2002 00019	Denmark
0613371	2002C/022	Belgium		PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825

Market Dynamics and Financial Trajectory for SYMBICORT

Last updated: November 20, 2025

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Introduction

SYMBICORT, a combination inhaler containing budesonide and formoterol, is a leading therapeutic option for asthma and chronic obstructive pulmonary disease (COPD). Since its regulatory approval, SYMBICORT has maintained a significant position within the respiratory medication market. This article explores the evolving market dynamics influencing SYMBICORT's performance, analyzes its financial trajectory amid competitive and regulatory landscapes, and offers insights for stakeholders.

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Market Overview

The global respiratory drug market, fueled by rising prevalence of asthma and COPD, was valued at approximately USD 45 billion in 2022 and is projected to reach USD 60 billion by 2030, reflecting a compound annual growth rate (CAGR) of around 4.3% [1]. SYMBICORT, marketed by AstraZeneca, occupies a prominent niche within this space, particularly due to its combination therapy efficacy, convenience, and strong brand recognition.

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Market Dynamics Influencing SYMBICORT

1. Rising Disease Prevalence and Demographics

The increasing global burden of asthma and COPD predominantly drives demand for inhaler therapies. According to the Global Initiative for Asthma (GINA), approximately 262 million people globally suffer from asthma, with rising prevalence particularly in urbanized regions [2]. COPD affects over 200 million individuals worldwide, with prevalence expected to grow due to aging populations and environmental pollution.

This demographic shift elevates the need for effective maintenance therapies like SYMBICORT, which offers dual-action benefits—bronchodilation via formoterol and anti-inflammatory effects through budesonide. Established efficacy combined with safety profiles sustains its market relevance.

2. Patent Expiry and Generic Competition

SYMBICORT was initially launched in 2007. Patent protections often extend for 10–12 years post-approval, with some extensions possible due to regulatory delays or supplementary patents. The expiration of key patents, particularly in major markets like the U.S. (2019-2021), exposed SYMBICORT to biosimilar or generic competition—potentially impacting pricing and market share.

While AstraZeneca actively defends its market position via formulation patents and brand loyalty, the advent of generics in several jurisdictions has challenged pricing power. For instance, in the United States, the entry of generic versions has led to significant price erosion, pressuring revenue streams [3].

3. Regulatory Environment and Reimbursement Policies

Regulatory bodies influence market access and pricing. Stricter regulations or unfavorable reimbursement policies can impair sales. Conversely, inclusion in formularies and positive reimbursement decisions bolster uptake.

In many markets, regulators have endorsed corticosteroid/bronchodilator combination inhalers as standard treatment for moderate-to-severe asthma and COPD, reinforcing demand. However, reimbursement constraints or prior authorization requirements may impede widespread use, especially amidst cost-containment efforts.

4. Competitive Landscape

The respiratory inhaler market features several notable competitors, including:

• Fluticasone/Salmeterol (Advair/Seretide): Predominant in many regions, with a longer market presence.
• Budespod/Formoterol (generic and branded): Emerging as low-cost alternatives.
• Other fixed-dose combinations: Such as beclomethasone/formoterol and mometasone/formoterol.

The competitive pressure necessitates continuous innovation, formulary positioning, and differentiated marketing strategies from AstraZeneca to maintain SYMBICORT's market share.

5. Innovation and Pipeline Developments

AstraZeneca's pipeline includes next-generation inhalers with improved drug delivery and digital health integration—enhancing adherence and personalized treatment. Demonstrated superiority or added features can sustain or enhance SYMBICORT's market relevance.

Financial Trajectory

1. Revenue Trends and Market Share

Since its launch, SYMBICORT has generated substantial revenue for AstraZeneca, with revenues reaching approximately USD 1.8 billion globally in 2021 [4]. The revenues experienced a plateau post-patent expiry, with some decline observed in regions impacted by generic competition. Nonetheless, strategic market expansion into emerging economies—such as China and India—has partially offset declines in mature markets.

2. Impact of Patent Expiration and Generics

Patent expirations around 2019-2021 precipitated a notable revenue decline in North America. Generic versions, sold at lower prices, reduced AstraZeneca's market share in key countries. However, the company mitigates this effect via:

• Strengthening presence in emerging markets.
• Offering authorized generics and value-based pricing.
• Enhancing formulary placements through clinician engagement.

3. Pricing and Reimbursement Strategies

AstraZeneca employs tiered pricing, patient assistance programs, and formulary negotiations to optimize revenue streams, particularly in markets with significant generic competition. In regions with favorable reimbursement and high disease prevalence, SYMBICORT continues to command premium pricing.

4. Future Revenue Projections

Forecasts project a moderate recovery trajectory over the next 3–5 years, driven by:

• Expanding patient access in emerging markets.
• Portfolio integration with digital adherence tools.
• Introduction of new formulations and delivery systems.

However, increased generic penetration and price pressures will temper growth rates, maintaining a CAGR of around 2–3% globally through 2028 [5].

5. Influence of Price Controls and Policy Changes

Legislative initiatives targeting drug pricing—especially in the U.S. and Europe—could further pressure revenues. AstraZeneca's strategic focus on value-based care and innovation aims to counterbalance these constraints.

Key Market Opportunities

• Digital integration: Incorporating smart inhalers for adherence monitoring.
• Biologic add-ons: Developing adjunct therapies targeting severe cases.
• Personalized medicine: Tailoring therapies based on genetic markers could enhance efficacy and market differentiation.
• Geographic expansion: Growing middle-income economies with rising respiratory disease burden.

Risks and Challenges

• Generic erosion: Continued entry of generics in established markets.
• Regulatory shifts: Stringent policies may limit pricing or access.
• Market saturation: Mature markets exhibit slow growth, prompting dependence on emerging markets.
• Competition innovation: Rapid developments by competitors may diminish SYMBICORT’s market segment.

Conclusion

SYMBICORT's market dynamics are shaped by a confluence of demographic trends, patent landscapes, regulatory frameworks, and competitive forces. While patent expirations initially pressured revenues, strategic geographic expansion, innovation, and value-driven approaches have stabilized its financial trajectory. Nonetheless, its future performance hinges on navigating a complex environment of generic competition, regulatory scrutiny, and technological advancements.

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Key Takeaways

• Rising respiratory disease prevalence sustains demand for therapies like SYMBICORT, especially in emerging markets.
• Patent expirations have led to revenue declines; strategic market expansion and innovation are essential for growth.
• Intense competition and generics pressure necessitate differentiation through formulation improvements and digital health integrations.
• Navigation of regulatory and reimbursement policies significantly influences profitability.
• Long-term growth hinges on leveraging digital health, geographic expansion, and personalized therapies, offsetting persistent challenges.

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FAQs

Q1: How has patent expiration affected SYMBICORT’s market share?
Patent expiry led to increased generic competition, particularly in North America, resulting in revenue decline and reduced market share. AstraZeneca offset this by expanding into emerging markets and emphasizing formulary positioning.

Q2: What strategies is AstraZeneca employing to sustain SYMBICORT's financial performance?
The company emphasizes geographic diversification, digital health integration, portfolio innovation, and targeted pricing/reimbursement strategies to enhance access and maintain revenue streams.

Q3: Are there upcoming competitors that could threaten SYMBICORT's market position?
Yes, new fixed-dose combination inhalers, innovative biologics, and next-generation inhaler devices are in development, potentially challenging SYMBICORT’s dominance.

Q4: How critical is digital health integration for SYMBICORT’s future?
Implementing smart inhalers and adherence tools can improve patient compliance, differentiate the product, and expand market share, making digital health a vital component of future strategy.

Q5: What is the outlook for SYMBICORT’s revenue over the next five years?
Projected to experience modest growth with a CAGR of 2–3%, driven by emerging markets expansion and innovation, albeit tempered by competitive and regulatory pressures.

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Sources:

[1] Grand View Research, "Respiratory Drugs Market Size & Trends" (2022).
[2] GINA Report, "Global Strategy for Asthma Management and Prevention" (2022).
[3] IQVIA, "Pharmaceutical Market Data, 2021."
[4] AstraZeneca Annual Report, 2021.
[5] EvaluatePharma, "Forecasting Respiratory Drugs Market," 2022.