FORMOTEROL FUMARATE; GLYCOPYRROLATE - Generic Drug Details

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

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

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

One supplier is listed for this compound.

Summary for FORMOTEROL FUMARATE; GLYCOPYRROLATE

International Patents:	187
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	4
DailyMed Link:	FORMOTEROL FUMARATE; GLYCOPYRROLATE at DailyMed

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

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 FORMOTEROL FUMARATE; GLYCOPYRROLATE

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

Sponsor	Phase
Chiesi Farmaceutici S.p.A.	Phase 3
Pearl Therapeutics, Inc.	Phase 3
Pearl Therapeutics, Inc.	Phase 2

See all FORMOTEROL FUMARATE; GLYCOPYRROLATE clinical trials

Pharmacology for FORMOTEROL FUMARATE; GLYCOPYRROLATE

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

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

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, 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

US Patents and Regulatory Information for 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	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes			Y
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes			Y

International Patents for FORMOTEROL FUMARATE; GLYCOPYRROLATE

Country	Patent Number	Title	Estimated Expiration
Hong Kong	1169027
World Intellectual Property Organization (WIPO)	2010138862
Taiwan	201109050	Compositions for pulmonary delivery of long-acting muscarinic antagonists and long-acting &bgr;2 adrenergic receptor agonists and associated methods and systems
Mexico	2011012685
European Patent Office	3111926	COMPOSITIONS, PROCÉDÉS ET SYSTÈMES POUR UNE ADMINISTRATION RESPIRATOIRE DE DEUX OU DE PLUSIEURS AGENTS ACTIFS (COMPOSITIONS, METHODS & SYSTEMS FOR RESPIRATORY DELIVERY OF TWO OR MORE ACTIVE AGENTS)
Japan	6169639

Supplementary Protection Certificates for FORMOTEROL FUMARATE; GLYCOPYRROLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	132019000000087	Italy		PRODUCT NAME: UNA COMBINAZIONE DI GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI) E FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI)(BEVESPI AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1339, 20181220
2435024	21C1020	France		PRODUCT NAME: COMBINAISON DE FORMOTEROL (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI), GLYCOPYRROLATE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET BUDESONIDE (Y COMPRIS LES SELS, ESTERS, SOLVATES OU ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); REGISTRATION NO/DATE: EU/1/20/1498 20201210
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
2435024	PA2021511	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209
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
2435025	CA 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220

FORMOTEROL FUMARATE; GLYCOPYRROLATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Formoterol Fumarate and Glycopyrrolate

Introduction

Formoterol fumarate and glycopyrrolate are key components in the treatment of chronic obstructive pulmonary disease (COPD) and other respiratory conditions. These medications, often combined in metered dose inhalers (MDIs), have shown significant efficacy and safety profiles, influencing their market dynamics and financial trajectories.

Market Overview

The market for COPD treatments, particularly those involving formoterol fumarate and glycopyrrolate, has seen substantial growth in recent years. This growth is driven by the increasing prevalence of COPD and the need for effective long-term maintenance treatments.

Prevalence of COPD

The prevalence of COPD has been a significant factor in the market growth. Studies indicate that the prevalence of COPD has remained relatively constant, but the population affected by it has grown due to demographic changes. For instance, the growth rate of populations with COPD has been approximately 1.3% annually[1].

Regulatory Environment

Regulatory approvals play a crucial role in the market dynamics of these drugs. The FDA has approved several MDI products containing formoterol fumarate and glycopyrrolate, such as the glycopyrrolate/formoterol fumarate (GFF) MDI, which has been shown to improve lung function and reduce exacerbations in COPD patients[2].

Efficacy and Safety

The efficacy and safety of formoterol fumarate and glycopyrrolate combinations have been extensively studied.

Clinical Trials

The PINNACLE studies, a series of Phase III clinical trials, demonstrated that GFF MDI significantly improved lung function and reduced the risk of exacerbations compared to monocomponents and placebo in patients with COPD. These trials highlighted the benefits of this combination in patients with higher symptom burdens and those with exacerbation histories[2].

Mechanism of Action

Glycopyrrolate acts as a long-acting muscarinic antagonist (LAMA), while formoterol fumarate acts as a long-acting beta-2 agonist (LABA). This combination works synergistically to open up the bronchial tubes, relieving symptoms such as cough, wheezing, and shortness of breath[4].

Cost-Effectiveness

The cost-effectiveness of these treatments is a critical factor in their market adoption.

Economic Evaluations

In China, a Markov model analysis showed that glycopyrrolate/formoterol was a clinically and cost-effective treatment for moderate-to-severe COPD, generating additional life-years and quality-adjusted life years (QALYs) at lower lifetime costs compared to tiotropium bromide. The negotiation of drug prices significantly increased the cost-effectiveness of this treatment[3].

Pricing and Access

The pricing of these medications can vary significantly depending on the region and healthcare policies. In many countries, negotiations and price controls have made these treatments more accessible to patients, thereby increasing their market penetration.

Market Trends

Growth in Sales

The sales of MDIs containing formoterol fumarate and glycopyrrolate have seen a significant increase. For example, the sales of HFC MDIs, which include these medications, increased by 75% from 80 million units to 140 million units between 2015 and 2020 in the United States[1].

Competitive Landscape

The market is competitive, with several pharmaceutical companies offering similar products. The introduction of new combinations, such as the budesonide/glycopyrrolate/formoterol fumarate (BGF) MDI, further diversifies the treatment options available to patients[5].

Financial Trajectory

Revenue Projections

Given the increasing prevalence of COPD and the proven efficacy of formoterol fumarate and glycopyrrolate combinations, revenue projections for these medications are positive. The market is expected to grow at a rate aligned with population growth and the increasing demand for effective COPD treatments.

Investment and Research

Pharmaceutical companies continue to invest in research and development to improve these treatments and expand their indications. For instance, the submission of drug master files (DMFs) for new propellants and the initiation of clinical trials for new combinations are indicative of ongoing investment in this area[1].

Regulatory and Environmental Considerations

Transition from HFCs

The pharmaceutical industry is transitioning from hydrofluorocarbons (HFCs) to more environmentally friendly propellants. This transition, while necessary for reducing greenhouse gas emissions, requires extensive clinical research and FDA approval, which can impact the financial trajectory of these products[1].

Patient Access and Affordability

Healthcare Policies

Healthcare policies, including drug price negotiations, play a crucial role in making these treatments affordable for patients. In regions where such policies are in place, the cost-effectiveness and accessibility of formoterol fumarate and glycopyrrolate combinations are significantly improved[3].

Conclusion

The market dynamics and financial trajectory for formoterol fumarate and glycopyrrolate are driven by their proven efficacy, growing demand due to the increasing prevalence of COPD, and favorable regulatory and economic environments. As the pharmaceutical industry continues to innovate and expand treatment options, these medications are poised for continued growth and adoption.

Key Takeaways

• Efficacy and Safety: Formoterol fumarate and glycopyrrolate combinations have demonstrated significant improvements in lung function and reduction in exacerbations in COPD patients.
• Cost-Effectiveness: These treatments are clinically and cost-effective, especially in regions with negotiated drug prices.
• Market Growth: The market for these medications is expected to grow in line with population growth and increasing demand for effective COPD treatments.
• Regulatory Environment: FDA approvals and ongoing research are crucial for the market dynamics of these drugs.
• Environmental Considerations: The transition from HFCs to more environmentally friendly propellants is ongoing.

FAQs

Q: What is the primary use of formoterol fumarate and glycopyrrolate in respiratory medicine?

A: Formoterol fumarate and glycopyrrolate are used as long-term maintenance treatments for chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Q: How do formoterol fumarate and glycopyrrolate work in the body?

A: Glycopyrrolate acts as a long-acting muscarinic antagonist (LAMA), while formoterol fumarate acts as a long-acting beta-2 agonist (LABA), working synergistically to open up the bronchial tubes and relieve symptoms.

Q: What are the key findings from the PINNACLE studies on GFF MDI?

A: The PINNACLE studies showed that GFF MDI improved lung function and reduced the risk of exacerbations compared to monocomponents and placebo in COPD patients.

Q: How does the cost-effectiveness of glycopyrrolate/formoterol compare to other treatments?

A: Glycopyrrolate/formoterol has been shown to be cost-effective, generating additional life-years and QALYs at lower lifetime costs compared to other treatments like tiotropium bromide.

Q: What are the environmental considerations for MDIs containing formoterol fumarate and glycopyrrolate?

A: The pharmaceutical industry is transitioning from HFCs to more environmentally friendly propellants, which requires extensive clinical research and FDA approval.

Sources

1. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry.
2. PubMed: Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler.
3. PubMed: How the cost-effectiveness results change in the China health policy.
4. Mayo Clinic: Glycopyrrolate and formoterol (inhalation route).
5. Patsnap: Budesonide/Formoterol fumarate/Glycopyrronium Bromide.