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	8,875,699*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	8,575,137*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	021929-002	Jul 21, 2006	8,461,211*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	5,972,919
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	6,641,800

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
Malaysia	135868	INHALER CAP STRAP
European Patent Office	1696987	COURROIE POUR BOUCHON D'INHALATEUR (INHALER CAP STRAP)
World Intellectual Property Organization (WIPO)	2006004496
Russian Federation	2004122921	КОМПОЗИЦИЯ ДЛЯ ИНГАЛЯЦИИ
Iceland	2703
New Zealand	534452	Pharmaceutical composition containing formoterol and budesonide used in inhalers

Supplementary Protection Certificates for SYMBICORT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0613371	SPC016/2002	Ireland		SPC016/2002: 20041105, EXPIRES: 20150824
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
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	CA 2002 00019	Denmark

Market Dynamics and Financial Trajectory of SYMBICORT

Last updated: December 13, 2025

Executive Summary

SYMBICORT (budesonide/formoterol fumarate dihydrate) is a leading inhaled combination medication primarily prescribed for asthma and COPD management. Its unique position within respiratory pharmacotherapy, combined with evolving healthcare policies, competitive product landscape, and patent life cycle considerations, significantly influences its market dynamics and financial trajectory. This comprehensive analysis explores the current market landscape, drivers shaping demand, competitive forces, pricing strategies, and forecasts over the next decade.

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What Is SYMBICORT and Why Is It Significant?

SYMBICORT is a fixed-dose combination of budesonide, an inhaled corticosteroid (ICS), and formoterol, a long-acting beta-agonist (LABA). Approved by the FDA in 2009, it primarily treats persistent asthma and COPD with proven efficacy in reducing exacerbations and improving lung function. Its significance lies in its dual mechanism of action, offering symptom control and reducing systemic corticosteroid use.

Key Specifications:

Attribute	Details
Approvals	FDA (2009), EMA (2010), various international agencies
Dosage Forms	Inhaler (Metered Dose Inhaler)
Indications	Asthma, COPD
Marketed By	AstraZeneca

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What Are the Current Market Drivers for SYMBICORT?

1. Epidemiological Trends

• Prevalence of Asthma and COPD: Globally, over 339 million people suffer from asthma[1], and approximately 384 million live with COPD[2]—both conditions require maintenance inhalers like SYMBICORT.
• Demographic Shifts: Aging populations in North America, Europe, and Asia Pacific boost respiratory disease prevalence, expanding the potential patient pool.

2. Healthcare Policy and Guidelines

• GOLD and GINA Guidelines: Favor multi-drug inhalers for persistent asthma and COPD, positioning SYMBICORT favorably.
• Reimbursement and Access: Favorable insurance coverage in key regions enhances uptake.

3. Product Differentiation and Clinical Efficacy

• Combination Efficiency: SYMBICORT's dual mechanism simplifies treatment regimens.
• Inhaler Device Innovation: Easy-to-use inhalers enhance adherence.

4. Competitive Landscape

• Competing products include Fluticasone/Salmeterol (Advair), Breo Ellipta (Vilanterol/Fluticasone), and generics.
• Patent protections and exclusivity arrangements, primarily in developed markets, sustain sales.

5. Market Penetration and Physician Prescribing Habits

• Increasing awareness of combined therapy advantages supports prescription rates.
• Key markets: US, EU, Japan, and emerging markets.

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What Are the Market Challenges and Competitive Forces?

1. Patent Expirations and Generic Competition

• Patent life for the original formulation largely lapsed in key regions by 2019, opening the door for generics.
• Price erosion resulting from generics reduces margins for branded SYMBICORT.

2. Pricing Pressures and Reimbursement Policies

• Governments and payers aim to control healthcare costs, pressuring drug prices.
• Managed care organizations prioritize cost-effective alternatives.

3. Regulatory and Environmental Factors

• Stricter inhaler propellant regulations (e.g., HFA versus new eco-friendly propellants) impact manufacturing costs and formulation stability.

4. Market Saturation and Competitive Dynamics

Competitor	Product Name	Market Share	Notable Features
GlaxoSmithKline	Advair (Fluticasone/Salmeterol)	~25% (Global in COPD/Ashtma)	Market leader, extensive clinical data
GSK	Breo Ellipta (Vilanterol/Fluticasone)	Growing	Once-daily dosing, increased adherence
Boehringer Ingelheim	Spiolto (Tiotropium/Olodaterol)	Niche market	Alternative therapy for COPD

5. Innovation in Delivery Devices

• Digital inhalers and smart devices promote adherence, potentially shifting the competitive landscape.

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What Is the Financial Trajectory for SYMBICORT?

Historical Revenue Performance

• AstraZeneca reported BRL 11.3 billion (~$2.2B USD) in global respiratory sales in 2022, with SYMBICORT contributing approximately $600 million (est. 27%), though exact figures are proprietary.

Revenue Drivers

• U.S. Market: Largest contributor (~50%), driven by high asthma prevalence and insurance coverage.
• Europe and Japan: Moderate contribution, with growth prospects as COPD prevalence rises.
• Emerging Markets: Rapid growth potential due to increasing healthcare access and awareness.

Patent and Lifecycle Management

Year	Key Milestone	Impact
2010	Patent protections in the U.S.	Revenue stabilization, market exclusivity
2019	Patent expiry in various jurisdictions	Revenue decline, entry of generics
2021-2025	Launch of authorized generics and biosimilars	Price competition, margin compression

Forward-Looking Revenue Projections

Year	Projected Revenue (USD Millions)	Assumptions
2023	~$500 million	Continued generic competition, slowing growth
2025	~$400 million	Market saturation, price erosion
2030	~$300 million	Fragmented competition, regulatory challenges

Strategic Initiatives to Sustain Revenue

• Line Extensions: Development of new formulations (e.g., dry powder inhalers).
• Market Expansion: Focus on emerging markets with large unmet needs.
• Value-based Pricing: Incorporating digital adherence tools to demonstrate improved outcomes.

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How Do Market Penetration and Pricing Strategies Influence Financial Outcomes?

• Premium Pricing: Maintained in markets with strong brand loyalty and formulary placement.
• Price Erosion Post-Patent: Typically 30-50% decline over 3-5 years following patent expiry.
• Volume Growth: Driven by increased disease prevalence and expanded access in emerging markets.
• Reimbursement Policies: Variability influences sales; countries with universal healthcare see more consistent demand.

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What Are the Key Forecasting Assumptions and Limitations?

Assumption	Impact
Continued prevalence of respiratory diseases	Stronger demand in aging populations
No major regulatory hurdles	Sustained market access
Successful development and launch of line extensions	Revenue uplift and patient adherence improvements
Generic market penetration accelerates	Revenue decline, necessitating innovation and market differentiation

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Comparative Analysis: SYMBICORT vs. Key Competitors

Parameter	SYMBICORT	Advair (GSK)	Breo Ellipta (GSK)	Spiolto (BI)
Approval Year	2009	1996	2013	2017
Dose Frequency	BID	BID	Once daily	Once daily
Market Share (est.)	15-20% (globally)	~25%	Growing	Niche
Patent Status	Lapsed in several markets	Expired in 2018	Active	Active

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What Are the Key Regulatory and Policy Influences?

1. Global Respiratory Treatment Guidelines

• Favor combination inhalers with proven efficacy.
• Encourage adherence through simplified regimens.

2. Reimbursement and Pricing Policies

• Cost-containment policies impact sales.
• Preference for generic or biosimilar options in many markets.

3. Environmental Regulations

• Drive formulation changes that could influence manufacturing costs and availability.

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Key Takeaways

Insight	Actionable Strategy
Patent expirations have increased generic competition, pressuring margins	Invest in line extensions and pipeline innovations
Rising prevalence of respiratory diseases in emerging markets	Prioritize market entry strategies and local partnerships
Healthcare policies favor combination therapies for adherence	Focus sales and marketing efforts on clinician education
Technological advancements in inhaler devices influence adherence	Incorporate digital health solutions in product offerings
Pricing compression post-patent expiry necessitates cost-effective manufacturing	Optimize supply chain and explore biosimilar opportunities

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Frequently Asked Questions (FAQs)

1. What is the current patent status of SYMBICORT?

Most primary patents for SYMBICORT expired in key regions by 2019, leading to increased availability of generics, which impacts its pricing power and revenue.

2. How does SYMBICORT compare to its main competitors in efficacy?

Clinical trials have demonstrated comparable efficacy between SYMBICORT and competitors like Advair and Breo Ellipta in managing asthma and COPD, with differences primarily in dosing frequency and device usability.

3. What are the future growth prospects for SYMBICORT?

Growth prospects depend on geographic expansion, pipeline innovations, and regulatory environment stability. Emerging markets offer significant upside amidst health policy shifts favoring combination therapies.

4. How does the environmental impact affect inhaler formulations?

Regulations restricting use of certain propellants (e.g., HCFCs replaced by HFA) necessitate reformulations, which can affect manufacturing costs and supply chain stability.

5. What strategies can AstraZeneca adopt to sustain SYMBICORT sales?

Strategies include developing line extensions, investing in digital adherence technology, expanding into underserved markets, and leveraging contract manufacturing for cost efficiencies.

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References

[1] WHO. “Asthma Fact Sheet,” 2022.
[2] WHO. “Chronic Obstructive Pulmonary Disease Fact Sheet,” 2022.
[3] AstraZeneca Annual Report, 2022.
[4] GOLD Guidelines, 2023.
[5] GINA Report, 2023.

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In conclusion, SYMBICORT remains a pivotal inhaler in the respiratory market, with its future trajectory shaped by patent landscapes, clinical positioning, technological innovation, and global demographic trends. Strategic adaptation to evolving policies and competitive pressures will be essential for sustaining its market share and financial performance.