BUDESONIDE; FORMOTEROL FUMARATE - Generic Drug Details

What are the generic drug sources for budesonide; formoterol fumarate and what is the scope of freedom to operate?

Budesonide; formoterol fumarate is the generic ingredient in five branded drugs marketed by Astrazeneca, Mylan, Teva Pharms Usa Inc, and Astrazeneca Ab, and is included in five NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Budesonide; formoterol fumarate has one hundred and ninety-four patent family members in thirty-two countries.

Summary for BUDESONIDE; FORMOTEROL FUMARATE

International Patents:	194
US Patents:	9
Tradenames:	5
Applicants:	4
NDAs:	5
Clinical Trials:	34
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BUDESONIDE; FORMOTEROL FUMARATE
DailyMed Link:	BUDESONIDE; FORMOTEROL FUMARATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BUDESONIDE; FORMOTEROL FUMARATE

Constraining patent/regulatory exclusivity:

NEW STRENGTH

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.

Recent Clinical Trials for BUDESONIDE; FORMOTEROL FUMARATE

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

Sponsor	Phase
Henan University of Traditional Chinese Medicine	NA
Parexel	PHASE4
AstraZeneca	PHASE4

See all BUDESONIDE; FORMOTEROL FUMARATE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BUDESONIDE; FORMOTEROL FUMARATE

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for BUDESONIDE; FORMOTEROL FUMARATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa Inc	BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	212212-002	Apr 23, 2026	AB	RX	No	No
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	8,815,258
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699-002	Mar 15, 2022	AB	RX	No	No
Astrazeneca	SYMBICORT AEROSPHERE	budesonide; formoterol fumarate	AEROSOL, METERED;INHALATION	216579-002	Apr 27, 2026		RX	Yes	Yes	9,415,009
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-002	Apr 27, 2026		RX	Yes	Yes	9,415,009
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	11,833,292		Y

International Patents for BUDESONIDE; FORMOTEROL FUMARATE

Country	Patent Number	Title	Estimated Expiration
Argentina	076621
Argentina	076806
Argentina	076807
Argentina	121758
Argentina	122477
Argentina	122478

Supplementary Protection Certificates for BUDESONIDE; FORMOTEROL FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	CR 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER SOLVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERE ELLER SOLVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
2435024	122021000026	Germany		PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; AUTHORISATION NO/DATE: EU/1/20/1498 20201209
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	LUC00124	Luxembourg		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
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
2435024	2190014-7	Sweden		PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210

Last updated: February 13, 2026

Market Overview and Financial Outlook for Budesonide and Formoterol Fumarate

Budesonide and formoterol fumarate are combination inhalation products primarily used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Their market penetration hinges on a range of factors, including clinical efficacy, regulatory approvals, patent status, competitive landscape, and healthcare policy shifts.

Market Size and Growth Drivers

The global respiratory therapies market, including inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA), is expected to reach approximately $36 billion by 2027, with a compound annual growth rate (CAGR) of 4.5%, from an estimated $25.6 billion in 2022 [1].

Budesonide and formoterol fumarate occupy a significant segment within this space. Their combined use is prescribed for persistent asthma and COPD, with both drugs available in various dosage forms and delivery devices.

Key Market Segments

• Asthma: Approximately 358 million globally. ICS/LABA combinations cover 30-40% of treatment regimens post receipt of initial control.
• COPD: About 200 million cases. ICS/LABA combination therapies are prescribed for severe cases to reduce exacerbations.

Patent and Regulatory Landscape

• Patent Expiration: Many formulations of combination therapies including budesonide and formoterol fumarate face patent expirations between 2024-2026, opening market access for generic competitors.
• Regulatory Approvals: Both drugs have gained FDA approval; most generic entries occurred post-2015, with some recent approvals in emerging markets.

Competitive Environment

Major players include AstraZeneca, Teva, Mylan (now part of Viatris), and Sun Pharmaceutical, each offering various inhalers and formulations.

Company	Product Name	Key Markets	Patent Status
AstraZeneca	Symbicort	Global	Patent expired in 2022+
Teva	QVAR RediHaler (budesonide)	US, EU	Patent expires 2024
Mylan / Viatris	Formoterol fumarate inhalers	Multiple markets	Patent expirations from 2024

Revenue Projections

Global revenues for combination inhalers with budesonide and formoterol are projected to grow at approximately 5-7% CAGR through 2030, driven by increased adoption in emerging markets, increased prevalence of respiratory diseases, and expanded indications.

Approximate Revenue Breakdown (by Company)

• AstraZeneca: USD 2 billion in 2022, with a 5% CAGR expected.
• Teva and Viatris: USD 0.8 billion combined, with growth dependent on market expansion and generic uptake.

Price Trends and Market Entry Effects

Price erosion is observed post-patent expiry, with generic equivalents reducing average prices by 30-50%. This affects revenue trajectory but expands access and overall volume.

Risks and Opportunities

• Development of biosimilars and generics could significantly impact revenue streams post-expiration.
• Regulatory changes aimed at reducing healthcare costs could further expedite generic uptake.
• Innovation in inhaler technology or new combination therapies offers potential for premium pricing and market expansion.

Financial Trajectory Summary

Timeline	Market Trends	Revenue Outlook
2023-2024	Patent cliffs, imminent generic entries	Revenue decline for branded products
2025-2026	Increased generic penetration, regulatory changes	Stabilization or slight decline in revenues
2027-2030	Market saturation, pipeline innovations	Potential growth from new formulations

Key Takeaways

• Patent expirations around 2024-2026 are primary catalysts for market transition toward generics.
• The respiratory drug market demonstrates steady growth, driven by rising disease prevalence.
• The revenue trajectory for branded combination inhalers will decline post-patent expiry but may stabilize with new product launches or expanded indications.
• Companies actively invest in inhaler technology innovation to preserve margins and market share.
• Cost containment policies and healthcare reforms present both risks and opportunities for market participants.

FAQs

Q1: What factors influence the timing of generic entry for budesonide and formoterol fumarate?
A1: Patent status, regulatory approvals, manufacturing capabilities, and market demand dictate generic entry timing.

Q2: How do regulatory policies impact the pricing of these inhalers?
A2: Policies aimed at cost reduction and drug price negotiations typically accelerate generic adoption, reducing prices.

Q3: Are there emerging markets with high growth potential?
A3: Yes. Countries in Asia, Latin America, and Eastern Europe demonstrate significant growth due to increasing respiratory disease prevalence and expanding healthcare coverage.

Q4: What developments could alter the current market outlook?
A4: Advances in inhaler device technology, such as digital inhalers, or new combination drugs with improved efficacy could shift dynamics.

Q5: How does the competitive landscape influence future revenues?
A5: Increased competition from generics and biosimilars tends to compress margins but enhances market volume and access.

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References

[1] MarketsandMarkets. "Respiratory Drugs Market by Disease Type, Route of Administration, and Region — Global Forecast to 2027." Published 2022.