Budesonide; formoterol fumarate; glycopyrrolate - Generic Drug Details

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

Budesonide; formoterol fumarate; glycopyrrolate is the generic ingredient in one branded drug marketed by Astrazeneca Ab and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for budesonide; formoterol fumarate; glycopyrrolate

International Patents:	209
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	budesonide; formoterol fumarate; glycopyrrolate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for budesonide; formoterol fumarate; glycopyrrolate

Constraining patent/regulatory exclusivity:

8,703,806

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.

Pharmacology for budesonide; formoterol fumarate; glycopyrrolate

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists Cholinergic Muscarinic Antagonists Corticosteroid Hormone Receptor Agonists

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

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; glycopyrrolate

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	8,324,266
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		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	8,815,258
Astrazeneca Ab	BREZTRI AEROSPHERE	budesonide; formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	212122-001	Jul 23, 2020		RX	Yes	Yes	9,463,161		Y

International Patents for budesonide; formoterol fumarate; glycopyrrolate

Country	Patent Number	Title	Estimated Expiration
South Korea	20120015334	COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS
Ukraine	109529	КОМПОЗИЦІЇ ДЛЯ РЕСПІРАТОРНОЇ ДОСТАВКИ АКТИВНИХ АГЕНТІВ ТА ПОВ'ЯЗАНІ СПОСОБИ І СИСТЕМИ
South Korea	20120015334
Japan	2019108369	活性剤を呼吸器送達するための組成物、ならびに関連する方法および系 (COMPOSITIONS FOR RESPIRATORY DELIVERY OF ACTIVE AGENTS AND ASSOCIATED METHODS AND SYSTEMS)

Supplementary Protection Certificates for budesonide; formoterol fumarate; glycopyrrolate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	122021000026	Germany		PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2435024	LUC00208	Luxembourg		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES), DE GLYCOPYRRONIUM (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE BUDESONIDE (Y COMPRIS SES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/20/1468 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
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210

Budesonide; formoterol fumarate; glycopyrrolate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Budesonide, Formoterol Fumarate, and Glycopyrronium

Introduction to Budesonide, Formoterol Fumarate, and Glycopyrronium

Budesonide, formoterol fumarate, and glycopyrronium are components of a triple fixed-dose combination inhaler, commonly known as Breztri Aerosphere or BGF MDI. This medication is designed for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD).

Therapeutic Mechanism and Components

• Budesonide: An inhaled corticosteroid (ICS) that reduces inflammation in the lungs[4].
• Formoterol Fumarate: A long-acting beta2-agonist (LABA) that helps to relax the airway muscles, improving breathing[4].
• Glycopyrronium: A long-acting muscarinic antagonist (LAMA) that blocks the action of acetylcholine, further relaxing the airway muscles[4].

Market Drivers

Increasing Prevalence of COPD

The global market for this triple combination therapy is driven by the increasing prevalence of COPD, largely due to rising pollution levels, poor air quality, and lifestyle factors such as smoking and lack of exercise[3].

Clinical Efficacy

The approval of Breztri Aerosphere in the US was based on the Phase III ETHOS trial, which demonstrated a statistically significant reduction in the rate of exacerbations compared to dual-combination therapies. This clinical efficacy enhances market confidence and adoption[4].

Pharmacokinetics and Safety

Studies have shown that the pharmacokinetic parameters of budesonide, glycopyrronium, and formoterol fumarate are stable and comparable across different dosing regimens, indicating no significant drug-drug or within-formulation interactions. This stability contributes to the drug's safety profile and market appeal[2].

Market Size and Forecast

The global market for formoterol fumarate, a key component of this triple combination, is growing at a moderate pace. It is estimated to grow significantly from 2023 to 2030, driven by the increasing demand for respiratory medications due to poor air quality and rising pollution levels[3].

Competitive Landscape

The respiratory and immunology segment, where this drug is categorized, is highly competitive. However, AstraZeneca's Breztri Aerosphere stands out due to its unique triple-combination formula and the positive outcomes from clinical trials such as the ETHOS study. This differentiation helps in capturing a significant market share[4].

Financial Trajectory

Approval and Regulatory Impact

The approval by the US FDA in 2020 marked a significant milestone, opening up a large market for Breztri Aerosphere. This approval, based on robust clinical data, has positively impacted the financial trajectory of the drug by ensuring widespread adoption and reimbursement by healthcare systems[4].

Revenue Growth

Given the growing demand for effective COPD treatments and the drug's proven efficacy, the revenue from Breztri Aerosphere is expected to increase substantially. AstraZeneca's focus on respiratory and immunology as a key growth driver further supports the financial growth potential of this medication[4].

Market Penetration

The drug's market penetration is enhanced by its delivery in a pressurized metered-dose inhaler, which is user-friendly and effective. This ease of use, combined with the drug's clinical benefits, is likely to increase patient compliance and drive market growth[4].

Challenges and Restraints

Awareness and Access

Despite the growing demand, the market faces challenges such as lack of awareness about COPD and its treatments, as well as limited access to skilled healthcare professionals in some regions. These factors can hamper the growth of the global formoterol fumarate market, including the triple combination therapy[3].

Competition from Alternative Therapies

The market is also subject to competition from other COPD treatments, including dual-combination therapies. However, the unique triple-combination formula of Breztri Aerosphere and its proven clinical benefits help it maintain a competitive edge[4].

Key Takeaways

• Increasing Demand: The market is driven by the increasing prevalence of COPD due to poor air quality and lifestyle factors.
• Clinical Efficacy: The drug has shown significant reductions in exacerbation rates and improvements in lung function in clinical trials.
• Stable Pharmacokinetics: The pharmacokinetic parameters of the components are stable and comparable, ensuring safety and efficacy.
• Financial Growth: The drug's approval and positive clinical outcomes are expected to drive revenue growth.
• Market Differentiation: The unique triple-combination formula sets it apart in a competitive market.

FAQs

Q: What is the therapeutic mechanism of Breztri Aerosphere?

A: Breztri Aerosphere combines budesonide (an ICS), glycopyrronium (a LAMA), and formoterol fumarate (a LABA) to reduce inflammation, relax airway muscles, and improve breathing in COPD patients.

Q: What clinical trial data supports the approval of Breztri Aerosphere?

A: The approval was based on the Phase III ETHOS trial, which showed a statistically significant reduction in the rate of exacerbations compared to dual-combination therapies.

Q: How does the pharmacokinetics of BGF MDI impact its safety and efficacy?

A: The pharmacokinetic parameters of budesonide, glycopyrronium, and formoterol fumarate are stable and comparable, indicating no significant drug-drug or within-formulation interactions, which enhances the drug's safety and efficacy.

Q: What are the key drivers of the global formoterol fumarate market?

A: The market is driven by increasing pollution levels, poor air quality, and lifestyle factors such as smoking and lack of exercise, leading to a higher prevalence of COPD.

Q: How does Breztri Aerosphere differentiate itself in the competitive COPD treatment market?

A: The unique triple-combination formula and positive outcomes from clinical trials such as the ETHOS study differentiate Breztri Aerosphere and support its market position.

Sources

1. Patsnap: Budesonide/Formoterol fumarate/Glycopyrronium Bromide.
2. PubMed: Pharmacokinetics of budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler.
3. Verified Market Research: Formoterol Fumarate Market Size, Share, Opportunities & Forecast.
4. AstraZeneca: Breztri Aerosphere approved in the US for the maintenance treatment of patients with COPD.
5. NCBI: Benefits of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler.