Budesonide; formoterol fumarate dihydrate - Generic Drug Details

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

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

Budesonide; formoterol fumarate dihydrate has one hundred and sixty-two patent family members in thirty-nine countries.

Three suppliers are listed for this compound.

Summary for budesonide; formoterol fumarate dihydrate

International Patents:	162
US Patents:	5
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Clinical Trials:	11
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for budesonide; formoterol fumarate dihydrate
DailyMed Link:	budesonide; formoterol fumarate dihydrate at DailyMed

Recent Clinical Trials for budesonide; formoterol fumarate dihydrate

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

Sponsor	Phase
Cipla Ltd.	Phase 3
Actavis Inc.	Phase 3
Teva Pharmaceuticals USA	Phase 3

See all budesonide; formoterol fumarate dihydrate clinical trials

Pharmacology for budesonide; formoterol fumarate dihydrate

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for budesonide; formoterol fumarate dihydrate

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

Paragraph IV (Patent) Challenges for BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE

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 budesonide; formoterol fumarate dihydrate

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	021929-002	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	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	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	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	021929-002	Jul 21, 2006	AB	RX	Yes	Yes					Y
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006	AB	RX	Yes	Yes					Y

Expired US Patents for budesonide; formoterol fumarate dihydrate

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
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	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	021929-001	Jul 21, 2006
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-001	Jul 21, 2006
Astrazeneca	SYMBICORT	budesonide; formoterol fumarate dihydrate	AEROSOL, METERED;INHALATION	021929-002	Jul 21, 2006

EU/EMA Drug Approvals for budesonide; formoterol fumarate dihydrate

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 budesonide; formoterol fumarate dihydrate

Country	Patent Number	Title	Estimated Expiration
Taiwan	200613019	Inhaler device
China	1882371	Inhaler cap strap
Denmark	200700256
Portugal	1768728
Brazil	PI0609459	elemento contador de dispositivo inalador
Slovenia	1696987
Canada	2570078	INHALATEUR REDUISANT LE RISQUE D'ERREUR DE CALCUL DES DOSES (INHALER DEVICE THAT REDUCES THE RISK FOR MISCOUNTING A DOSAGE)

Supplementary Protection Certificates for budesonide; formoterol fumarate dihydrate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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

Budesonide; formoterol fumarate dihydrate Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Budesonide and Formoterol Fumarate Dihydrate

Introduction

Budesonide and Formoterol Fumarate Dihydrate, commonly known by the brand name Symbicort, is a combination inhaler used to treat asthma and Chronic Obstructive Pulmonary Disease (COPD). This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this medication.

Market Size and Growth

The budesonide inhaler market, which includes budesonide and formoterol fumarate dihydrate, was valued at US$ 6.8 billion in 2023. It 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 of Growth

Several factors are driving the growth of the budesonide and formoterol fumarate dihydrate market:

Increasing Prevalence of Respiratory Diseases

The rise in the number of patients affected by asthma and COPD worldwide is a significant driver. Poor air quality due to rising pollution levels and lifestyle factors such as lack of exercise, bad dietary choices, and smoking contribute to the increasing incidence of respiratory issues[1][3].

Generic Versions and Affordability

The introduction of generic versions of budesonide inhalers by key players has widened the consumer base, especially in low- and middle-income economies. For instance, Viatris launched Breyna, a generic version of AstraZeneca’s Symbicort, in collaboration with Kindeva, which is approved by the U.S. FDA for COPD and asthma patients[1].

Cost-Effectiveness

Studies have shown that budesonide/formoterol maintenance and reliever therapy (SMART) is cost-effective compared to higher fixed-dose regimens. This approach reduces severe exacerbations at a lower or similar overall cost, making it an attractive option for both patients and healthcare systems[2].

Regional Market Analysis

North America

North America holds the largest share in the budesonide inhaler market and is expected to maintain this dominance during the forecast period. The early adoption of asthma treatments and the high incidence of asthma in the region, particularly in the United States, contribute to this market leadership[1].

Asia Pacific and Other Regions

The Asia Pacific region is also experiencing significant growth due to increasing awareness of asthma and its treatment. Europe and the Middle East & Africa regions are also crucial, with market growth driven by the rising prevalence of respiratory diseases and the availability of generic and branded treatments[1][3].

Market Segmentation

The market is segmented based on several factors:

Dosage Form

The market is segmented into aerosols, dry powder, suspension, and spray forms. Aerosols and dry powder forms are particularly popular due to their ease of use and effectiveness[1].

Strength

The medication is available in various strengths, such as 0.25 mg and 0.5 mg, catering to different patient needs and treatment protocols[1].

Indication

Budesonide and formoterol fumarate dihydrate are primarily used for asthma and COPD. The market is also exploring its use for other respiratory conditions[1].

Distribution Channels

Hospital pharmacies account for the largest share in the distribution of budesonide inhalers. Retail pharmacies and online channels are also significant, especially with the increasing trend of telemedicine and online healthcare services[1].

Competitive Landscape

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

Mechanism and Therapeutic Areas

Budesonide and formoterol fumarate dihydrate work as glucocorticoid receptor agonists and beta-2 adrenergic receptor agonists, respectively. This combination provides both anti-inflammatory and bronchodilatory effects, making it highly effective in managing asthma and COPD symptoms[5].

Financial Impact

The financial trajectory of budesonide and formoterol fumarate dihydrate is positive, driven by increasing demand and the introduction of generic versions. The cost-effectiveness of SMART therapy and the expanding consumer base in low- and middle-income economies further support the financial growth of this market[1][2].

Key Takeaways

• The budesonide inhaler market, including budesonide and formoterol fumarate dihydrate, is projected to grow significantly due to rising respiratory disease prevalence and the introduction of generic versions.
• North America dominates the market, but the Asia Pacific region is also experiencing substantial growth.
• The medication is available in various dosage forms and strengths, catering to different patient needs.
• Hospital pharmacies are the primary distribution channels, but retail and online channels are gaining importance.
• The competitive landscape is driven by innovation and expansion by key pharmaceutical companies.

Frequently Asked Questions (FAQs)

Q: What is the projected market size of the budesonide inhaler market by 2034? A: The budesonide inhaler market is expected to reach US$ 13.6 billion by 2034[1].

Q: What are the key drivers of the budesonide and formoterol fumarate dihydrate market? A: The key drivers include the increasing prevalence of respiratory diseases, the introduction of generic versions, and the cost-effectiveness of SMART therapy[1][2].

Q: Which region dominates the budesonide inhaler market? A: North America holds the largest share in the budesonide inhaler market[1].

Q: What are the primary dosage forms of budesonide and formoterol fumarate dihydrate? A: The primary dosage forms are aerosols, dry powder, suspension, and spray[1].

Q: Who are the key players in the budesonide and formoterol fumarate dihydrate market? A: Key players include Pfizer Inc., Cipla Ltd., Lupin Limited, and AstraZeneca, among others[1].

Cited Sources:

1. Transparency Market Research - Budesonide Inhaler Market Size, Share & Trends, Forecast - 2034
2. PubMed - Cost-effectiveness of budesonide/formoterol for maintenance and reliever therapy
3. Verified Market Research - Formoterol Fumarate Market Size, Share, Opportunities & Forecast
4. Patsnap Synapse - Budesonide/Formoterol fumarate/Glycopyrronium Bromide
5. Patsnap Synapse - Budesonide/Formoterol Fumarate Dihydrate