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 four branded drugs marketed by Astrazeneca, Mylan, and Astrazeneca Ab, and is included in four NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Summary for BUDESONIDE; FORMOTEROL FUMARATE

International Patents:	187
US Patents:	14
Tradenames:	4
Applicants:	3
NDAs:	4
Clinical Trials:	30
DailyMed Link:	BUDESONIDE; FORMOTEROL FUMARATE at DailyMed

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

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
Cipla Ltd.	Phase 3
AstraZeneca	N/A
ShiYue Li	N/A

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
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes			Y
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	AB	RX	Yes	Yes					Y
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006	AB	RX	Yes	Yes					Y
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes			Y
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699-002	Mar 15, 2022	AB	RX	No	No
Mylan	BREYNA	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	211699-001	Mar 15, 2022	AB	RX	No	No
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	AB	RX	Yes	Yes					Y

International Patents for BUDESONIDE; FORMOTEROL FUMARATE

Country	Patent Number	Title	Estimated Expiration
China	107412212	经肺递送长效毒蕈碱拮抗剂及长效β2肾上腺素能受体激动剂的组合物及相关方法与系统 (Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting beta2 adrenergic receptor agonists and associated methods and systems)
Canada	2763941	COMPOSITIONS, METHODES ET SYSTEMES PERMETTANT UNE ADMINISTRATION PAR VOIE RESPIRATOIRE DE DEUX PRINCIPES ACTIFS OU PLUS (COMPOSITIONS, METHODS & SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS)
Brazil	PI1011508
Poland	2435023
Brazil	PI1011220
Netherlands	300995
European Patent Office	2435025	ADMINISTRATION PAR VOIE RESPIRATOIRE DE PRINCIPES ACTIFS (RESPIRATORY DELIVERY OF ACTIVE AGENTS)

Supplementary Protection Certificates for BUDESONIDE; FORMOTEROL FUMARATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2435024	C202130025	Spain		PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209
2435025	19C1040	France		PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220
2435025	2019C/532	Belgium		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435024	CA 2021 00014	Denmark		PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210
2435025	122019000068	Germany		PRODUCT NAME: KOMBINATION VON GLYCOPYRROLAT, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON, UND FORMOTEROL, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1339 20181218
2435025	PA2019014	Lithuania		PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218

BUDESONIDE; FORMOTEROL FUMARATE Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Budesonide and Formoterol Fumarate

Market Overview

The market for budesonide and formoterol fumarate, a combination used in the treatment of asthma and chronic obstructive pulmonary disease (COPD), is experiencing significant growth driven by several key factors.

Market Size and Growth

As of 2023, the budesonide inhaler market was valued at US$ 6.8 billion and is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.6% from 2024 to 2034, reaching US$ 13.6 billion by the end of the forecast period[1].

Key Drivers

Increasing Prevalence of Respiratory Diseases

The rising number of patients affected by asthma and COPD worldwide is a major driver of the market. These chronic respiratory diseases are becoming more prevalent, leading to an increased demand for effective treatments like budesonide and formoterol fumarate[1][4].

Generic Versions and Affordability

The introduction of generic versions of budesonide inhalers by key players has expanded the consumer base, particularly in low- and middle-income economies. This affordability factor is crucial in widening the market reach[1].

Technological Innovations

Companies are working on innovative treatments, such as the provision of budesonide-formoterol over the counter (OTC) for mild asthma, which enhances preventive measures and improves patient outcomes[1].

Market Segmentation

By Product Type

The market is segmented into inhalants and nebulizers, with inhalants being the dominant segment. The dosage forms include aerosols, dry powder, and suspension, each catering to different patient needs and preferences[1][4].

By Distribution Channel

Hospital pharmacies accounted for the largest share in 2023, indicating a strong presence in the healthcare system. Other distribution channels include retail pharmacies and online platforms[1].

By Region

North America holds the largest share in the budesonide inhaler market and is expected to maintain this position during the forecast period. Other significant regions include Europe, Asia-Pacific, and the Middle East & Africa[1][4].

Financial Trajectory

Cost-Effectiveness

Studies have shown that budesonide-formoterol combination is cost-effective compared to other treatments. For instance, a study using German unit costs found that budesonide-formoterol resulted in significantly lower total healthcare costs per patient over a 12-week period compared to fluticasone propionate[2].

Revenue Growth

The revenue growth in the budesonide inhaler market is driven by the increasing adoption of these inhalers due to their effectiveness in managing asthma and COPD symptoms. The launch of generic versions, such as Breyna (budesonide and formoterol fumarate dehydrate) Inhalation Aerosol by Viatris, further boosts market revenue[1].

Competitive Landscape

The market is competitive with key players such as Pfizer Inc., Cipla Ltd., Lupin Limited, Cosmo Pharmaceuticals SA, and AstraZeneca. These companies are continuously innovating and expanding their product portfolios to capture a larger market share[1][4].

Market Opportunities

Rising Generic Versions

The increasing number of launches of generic versions of budesonide inhalers presents a significant opportunity for market expansion. These generic versions are more affordable and accessible to a broader patient population[1][4].

Innovation in Inhaled Therapy

Further innovation in inhaled therapy for airway diseases is another opportunity. Companies are exploring new formulations and delivery mechanisms to improve patient outcomes and compliance[1][4].

Market Challenges

Side Effects

One of the challenges facing the budesonide inhaler market is the potential side effects associated with the medication. However, these are generally manageable and do not significantly deter market growth[4].

Availability of Alternatives

The presence of alternative treatments can pose a challenge, but the effectiveness and cost-efficiency of budesonide-formoterol combination make it a preferred choice for many patients and healthcare providers[4].

Regional Analysis

North America

North America is the dominant region in the budesonide inhaler market, driven by high healthcare spending and a large patient population suffering from respiratory diseases[1].

Europe

Europe is another significant market, with countries like Germany, the U.K., France, Italy, and Spain contributing substantially to the regional revenue[1].

Asia-Pacific

The Asia-Pacific region is growing rapidly due to an increasing prevalence of respiratory diseases and improving healthcare infrastructure. Countries like China, India, and Japan are key markets in this region[1][4].

Key Takeaways

• The budesonide inhaler market is projected to grow significantly due to the increasing prevalence of asthma and COPD.
• Generic versions of budesonide inhalers are expanding the market reach, especially in low- and middle-income economies.
• The market is driven by cost-effectiveness, innovative treatments, and a strong distribution network.
• North America is the leading region, but Asia-Pacific is emerging as a significant market.
• Side effects and the availability of alternatives are challenges, but the benefits of budesonide-formoterol combination outweigh these factors.

FAQs

What is the projected market size of the budesonide inhaler market by 2034?

The budesonide inhaler market is expected to reach US$ 13.6 billion by 2034, growing at a CAGR of 6.6% from 2024 to 2034[1].

Which region dominates the budesonide inhaler market?

North America holds the largest share in the budesonide inhaler market and is expected to maintain this position during the forecast period[1].

What are the key drivers of the budesonide inhaler market?

The key drivers include the increasing prevalence of asthma and COPD, the introduction of generic versions, and innovations in inhaled therapy[1][4].

Is budesonide-formoterol combination cost-effective?

Yes, studies have shown that budesonide-formoterol combination is cost-effective compared to other treatments, resulting in lower total healthcare costs per patient[2].

What are the potential side effects of budesonide inhalers?

While budesonide inhalers are generally safe, they can have side effects such as oral thrush, cough, and headache, though these are typically manageable[3].

Sources

1. Transparency Market Research: Budesonide Inhaler Market Size, Share & Trends, Forecast - 2034.
2. PubMed: Cost-effectiveness analysis of budesonide/formoterol compared with fluticasone propionate.
3. Mayo Clinic: Budesonide and formoterol (inhalation route).
4. Research and Markets: Budesonide Inhaler Market Size, Share & Forecast to 2030.
5. PubMed: Cost-effectiveness of budesonide-formoterol vs inhaled epinephrine.