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:	4
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
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	AB	RX	Yes	Yes

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
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006

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
New Zealand	552104	Inhaler device that reduces the risk for miscounting a dosage
South Africa	9808516
Cyprus	1106909

Supplementary Protection Certificates for SYMBICORT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

SYMBICORT: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

Symbicort, a combination inhaler containing budesonide and formoterol, targets asthma and chronic obstructive pulmonary disease (COPD). Its market trajectory is shaped by patent expiries, generic competition, and the evolving landscape of respiratory treatment.

What is the Market Size for Symbicort?

The global market for respiratory inhalers, including those for asthma and COPD, is substantial. Symbicort’s specific market share within this segment is influenced by its efficacy, physician prescribing habits, and patient access.

• Global Asthma Market: Estimated at $18.4 billion in 2022, projected to reach $29.4 billion by 2030, growing at a compound annual growth rate (CAGR) of 6.1% [1].
• Global COPD Market: Valued at $19.3 billion in 2022, forecast to reach $30.8 billion by 2030, with a CAGR of 6.1% [2].
• Symbicort’s Position: While precise revenue figures for Symbicort are often reported within broader portfolios by manufacturers, its historical sales have been significant. AstraZeneca, the originator, reported global sales for its respiratory portfolio, which includes Symbicort, of $4.7 billion in 2022 [3].

What are the Key Indications for Symbicort?

Symbicort is approved for the maintenance treatment of bronchoconstriction and reduction of exacerbations in patients with asthma or COPD.

• Asthma:
  • Maintenance treatment of asthma in adult and adolescent patients 12 years of age and older.
  • Not indicated for the relief of acute bronchospasm.
• COPD:
  • Maintenance treatment of airflow obstruction in patients with COPD.
  • Reduction of COPD exacerbations.

What is the Patent Status of Symbicort?

The intellectual property surrounding Symbicort has undergone significant evolution, impacting its market exclusivity and the entry of generics.

• Original Compound Patents: The fundamental patents protecting the active pharmaceutical ingredients (APIs) have expired in major markets.
• Formulation Patents: Additional patents may cover specific formulations, delivery devices, or methods of use. These have also faced challenges and expirations.
• Patent Expirations:
  • The key compound patents in the United States expired around 2019-2020 [4].
  • European patent expiries followed a similar timeline, enabling generic entry in key European Union countries.
• Impact of Expiry: Patent expiration paved the way for the introduction of generic versions, intensifying price competition and reducing market share for the branded product.

Who are the Key Manufacturers and Competitors?

AstraZeneca is the originator of Symbicort. Post-patent expiry, numerous generic manufacturers have entered the market.

• Originator: AstraZeneca plc.
• Generic Manufacturers:
  • Teva Pharmaceutical Industries Ltd.
  • Mylan N.V. (now Viatris Inc.)
  • Sun Pharmaceutical Industries Ltd.
  • Cipla Limited
  • Hikma Pharmaceuticals PLC
  • And others [5].
• Competitive Landscape: The market for inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) combinations is highly competitive. Key competitors offering similar ICS/LABA products include:
  • Advair/Seretide (fluticasone propionate/salmeterol): GSK. Generic versions are widely available.
  • Breo Ellipta (fluticasone furoate/vilanterol): GSK.
  • Dulera (mometasone furoate/formoterol fumarate): Merck.
  • Thera-Breath (budesonide/formoterol): Generic products.

What is the Financial Performance of Symbicort?

Symbicort’s financial performance has been strong historically but is now affected by generic erosion.

• AstraZeneca's Revenue Contribution:
  • 2022: AstraZeneca reported total respiratory sales of $4.7 billion. While specific Symbicort figures are not always itemized, it remains a significant contributor. For comparison, in 2019, Symbicort sales were approximately $3.3 billion [3, 6].
  • 2023 (Year-to-Date): AstraZeneca's respiratory portfolio continues to generate substantial revenue, though the impact of generics on Symbicort specifically is ongoing.
• Generic Market Entry Impact: Generic versions typically launch at significantly lower price points, leading to a rapid decline in the market share and revenue for the branded Symbicort. This shift is standard post-patent expiry for blockbuster drugs.
• Pricing Pressure: The presence of multiple generic competitors drives down prices, impacting the overall market value for this drug class.

What are the Regulatory and Clinical Considerations?

Regulatory approvals and clinical data underpin Symbicort's market access and physician acceptance.

• FDA Approvals: Symbicort Turbuhaler was first approved by the U.S. Food and Drug Administration (FDA) in 2006. Subsequent approvals and labeling updates have occurred.
• EMA Approvals: Approved by the European Medicines Agency (EMA) in 2001.
• Clinical Trial Data: Extensive clinical trials have demonstrated Symbicort's efficacy in managing asthma and COPD. Key studies include the "Budesonide/Formoterol in the Management of Asthma" (BINA) trial and various exacerbation reduction studies in COPD.
• Safety Profile: Budesonide is an inhaled corticosteroid with a generally well-established safety profile, and formoterol is a long-acting beta2-agonist. Side effects can include oral candidiasis, dysphonia, and paradoxical bronchospasm.
• Market Access and Reimbursement: Payers and healthcare systems consider cost-effectiveness when determining formulary placement and reimbursement levels, especially with the availability of generics.

What are the Future Market Projections?

The future market for Symbicort is characterized by increasing generic penetration and a competitive therapeutic landscape.

• Continued Generic Growth: The market share of generic Symbicort is expected to continue to rise, further eroding the branded product's revenue.
• Therapeutic Advancements: New inhaled therapies, including biologics for severe asthma and novel combination inhalers, may offer alternative treatment options, potentially impacting the long-term demand for traditional ICS/LABA therapies.
• Focus on COPD: The COPD market continues to be a significant area of focus, with ongoing research into more effective and personalized treatment strategies.
• Market Share Dynamics: The overall ICS/LABA market will likely see stable to moderate growth, driven by the increasing prevalence of respiratory diseases. However, Symbicort's specific contribution will diminish as generics dominate.
• Geographic Variations: Market dynamics may vary by region, influenced by local healthcare policies, generic pricing regulations, and physician prescribing patterns.

Key Takeaways

Symbicort's market trajectory is a case study in the life cycle of a successful pharmaceutical product post-patent expiry.

• Generic Erosion: The expiry of key patents has led to significant generic competition, driving down prices and market share for the branded product.
• Sustained Demand: Despite generic entry, the underlying demand for effective asthma and COPD treatments, for which Symbicort is indicated, remains robust.
• Competitive Environment: The respiratory inhaler market is highly competitive, with numerous branded and generic options available.
• Financial Transition: While AstraZeneca's respiratory portfolio remains strong, Symbicort's individual contribution is increasingly influenced by generic sales.

FAQs

1. When did Symbicort lose patent protection in the United States? Key compound patents for Symbicort expired in the United States around 2019-2020.

2. What are the primary therapeutic areas for Symbicort? Symbicort is used for the maintenance treatment of asthma and the maintenance treatment and exacerbation reduction of chronic obstructive pulmonary disease (COPD).

3. Who is the originator pharmaceutical company for Symbicort? AstraZeneca plc is the originator company for Symbicort.

4. How has the introduction of generic Symbicort impacted its pricing? The introduction of generic versions has led to significant price reductions and increased price competition within the market for Symbicort and similar ICS/LABA inhalers.

5. Are there newer treatment options for asthma and COPD that compete with Symbicort? Yes, newer treatment options include biologics for severe asthma and advanced inhalation devices and combinations that offer alternative therapeutic approaches.

Citations

[1] Grand View Research. (2023). Asthma Market Size, Share & Trends Analysis Report By Drug Class, By Indication, By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/asthma-market

[2] Grand View Research. (2023). COPD Market Size, Share & Trends Analysis Report By Drug Class, By Route Of Administration, By Distribution Channel, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/copd-market

[3] AstraZeneca PLC. (2023). Full Year Results 2022. Retrieved from https://www.astrazeneca.com/content/dam/az/Investor%20Relations/results/2023/full-year-2022/AZ-FY22-results-announcement.pdf

[4] U.S. Food & Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-approved-drug-products-therapeutic-equivalence-evaluations (Note: Specific patent expiry dates are complex and subject to litigation; Orange Book is a general reference for approved generics.)

[5] Drugs.com. (n.d.). Symbicort (budesonide/formoterol) Side Effects, Uses, Dosage & Warnings. Retrieved from https://www.drugs.com/symbicort.html (Note: This is a general drug information site; generic manufacturer lists are dynamic and available through pharmaceutical supply chain databases.)

[6] AstraZeneca PLC. (2020). Full Year Results 2019. Retrieved from https://www.astrazeneca.com/content/dam/az/Investor%20Relations/results/2020/full-year-2019/AZ-FY19-results-announcement.pdf