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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 seven patents protecting this drug and one Paragraph IV challenge.

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

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 2021 were $4.6bn, indicating a strong incentive for generic entry (peak sales were $5.7bn in 2019).

There have been eleven 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

International Patents:	162
US Patents:	5
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Clinical Trials:	145
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
Morten Hostrup, PhD	N/A
University of Alberta	Phase 1
Cipla Ltd.	Phase 3

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

SYMBICORT is protected by five US patents.

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	7,587,988*PED				Y
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	AB	RX	Yes	Yes	8,387,615*PED				Y
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	AB	RX	Yes	Yes	8,875,699*PED				Y
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	8,616,196*PED				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	021929-001	Jul 21, 2006	8,575,137*PED
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	7,967,011*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	021929-001	Jul 21, 2006	6,641,800
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	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/004882 Budesonide/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/003953 Budesonide/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
Hong Kong	1112089	吸入器計數器 (INHALER DEVICE COUNTER)
Japan	4805923
Japan	2008504925
China	1188185
Japan	4959559

Supplementary Protection Certificates for SYMBICORT

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

Market Dynamics and Financial Trajectory for Symbicort

Introduction

Symbicort, a combination inhaler containing budesonide and formoterol, is a pivotal medication in the management of respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD). Here, we delve into the market dynamics and financial trajectory of Symbicort, highlighting its performance, market drivers, and future outlook.

Market Drivers

Several factors drive the demand for Symbicort:

Rising Prevalence of Respiratory Diseases

The increasing prevalence of asthma and COPD, exacerbated by rising pollution levels and lifestyle changes, has fueled the demand for effective treatments like Symbicort[3].

Personalized Medicine

The shift towards personalized medicine is a significant trend in the pharmaceutical market. Symbicort's combination of budesonide and formoterol allows for tailored treatment plans, catering to individual patient needs and increasing its adoption[3].

Affordability

The generic competition that emerged after Symbicort's patent expiration has lowered costs, making the medication more accessible to a broader patient base[3].

Financial Performance of Symbicort

Revenue Trends

Symbicort remains a key product for AstraZeneca, although its revenue has faced challenges in recent years. In Q4 2023, Symbicort saw a decline of 16% in the US due to the entry of a generic competitor, which significantly impacted its sales[1].

Global Market Leadership

Despite the decline in some regions, Symbicort continues to be the global market leader within the ICS/LABA class. It has maintained strong performance in emerging markets, particularly in Latin America[4].

Cost and Revenue Analysis

Studies have shown that Symbicort offers cost advantages over separate inhalers containing budesonide and formoterol. Adjustable dosing with Symbicort maintains control of asthma using less medication, resulting in lower treatment costs[5].

Impact of Generic Competition

Decline in Sales

The entry of generic competitors has led to a decline in Symbicort's sales, particularly in the US. In Q4 2023, this decline was noted as a significant factor in the overall revenue performance of AstraZeneca's respiratory and immunology segment[1].

Market Adaptation

Despite this, AstraZeneca continues to adapt by investing in other respiratory products such as Breztri and Saphnelo, which have shown strong growth and helped offset the decline in Symbicort sales[1].

Pharmacoeconomic Benefits

Cost Savings

Symbicort has been shown to offer pharmacoeconomic benefits by reducing total costs compared to separate inhalers or other combination therapies like fluticasone/salmeterol. The SMART (Single inhaler Maintenance And Reliever Therapy) approach with Symbicort improves asthma control, reduces exacerbations, and lowers both direct and indirect costs[5].

Clinical Advantages

In COPD, Symbicort offers clinical advantages over monocomponent therapies with little or no extra cost, making it a cost-effective option for managing COPD[5].

Future Outlook

Market Growth

The market for Symbicort is expected to be influenced by ongoing trends in personalized medicine and the increasing prevalence of respiratory diseases. While generic competition will continue to impact sales, the drug's clinical and cost benefits are likely to sustain its market presence[3].

AstraZeneca's Strategic Investments

AstraZeneca's strategy to invest in new launches and pipeline development is expected to drive overall revenue growth. The company anticipates double-digit revenue growth excluding COVID-19 medicines, which will help mitigate the impact of declining Symbicort sales[1].

Regional Performance

Emerging Markets

Symbicort has shown strong performance in emerging markets, particularly in Latin America and China. However, the decline in sales in the US and other established markets has been a significant factor in the overall revenue trends[1][4].

Established Markets

In established markets, the entry of generic competitors has led to a decline in Symbicort sales. However, AstraZeneca's diversified portfolio and investments in other products have helped maintain overall revenue growth in these regions[1].

Conclusion

Symbicort remains a crucial medication in the management of respiratory diseases, driven by its pharmacoeconomic benefits and clinical advantages. Despite facing challenges from generic competition, its market presence is sustained by its tailored treatment options and cost-effectiveness. AstraZeneca's strategic investments in new launches and pipeline development are expected to drive future growth, mitigating the impact of declining Symbicort sales.

Key Takeaways

• Market Leadership: Symbicort is the global market leader in the ICS/LABA class.
• Pharmacoeconomic Benefits: Symbicort offers lower treatment costs compared to separate inhalers or other combination therapies.
• Generic Competition: The entry of generic competitors has led to a decline in Symbicort sales, particularly in the US.
• Regional Performance: Strong performance in emerging markets, but declines in established markets.
• Future Outlook: Expected to be influenced by trends in personalized medicine and increasing prevalence of respiratory diseases.

FAQs

What are the key ingredients in Symbicort?

Symbicort contains budesonide, a corticosteroid, and formoterol, a long-acting beta-agonist[3].

How does Symbicort compare to other inhalers in terms of cost?

Symbicort offers lower treatment costs compared to separate inhalers containing budesonide and formoterol, and other combination therapies like fluticasone/salmeterol[5].

What is the impact of generic competition on Symbicort sales?

The entry of generic competitors has led to a significant decline in Symbicort sales, particularly in the US[1].

How does AstraZeneca plan to mitigate the decline in Symbicort sales?

AstraZeneca is investing in new launches and pipeline development to drive overall revenue growth and mitigate the impact of declining Symbicort sales[1].

What is the future outlook for Symbicort in the market?

The market for Symbicort is expected to be influenced by trends in personalized medicine and the increasing prevalence of respiratory diseases, despite the impact of generic competition[3].

Sources

1. AstraZeneca 8 February 2024 FY and Q4 2023 results Strong performance across key brands.
2. Symbicort SMART - Effective Treatment at a Lower Cost.
3. Budesonide/Formoterol (Symbicort) Manufacturing Plant Project Report 2024: Industry Trends, Plant Setup, Machinery, Raw Materials, Investment Opportunities, Cost and Revenue.
4. Full year and Q4 2022 results | AstraZeneca.
5. Symbicort: a pharmacoeconomic review - PubMed.