Formoterol fumarate - Generic Drug Details

What are the generic sources for formoterol fumarate and what is the scope of patent protection?

Formoterol fumarate is the generic ingredient in six branded drugs marketed by Novartis, Alembic, Lexenpharm, Lupin, Mankind Pharma, Micro Labs, Ritedose Corp, Teva Pharms Usa Inc, Wilshire Pharms Inc, Mylan Speclt, Astrazeneca, and Organon Llc, and is included in thirteen NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for formoterol fumarate. Thirteen suppliers are listed for this compound.

Summary for formoterol fumarate

US Patents:	7
Tradenames:	6
Applicants:	12
NDAs:	13
Drug Master File Entries:	12
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	248
Clinical Trials:	139
Patent Applications:	6,860
Drug Prices:	Drug price trends for formoterol fumarate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for formoterol fumarate
What excipients (inactive ingredients) are in formoterol fumarate?	formoterol fumarate excipients list
DailyMed Link:	formoterol fumarate at DailyMed

See drug prices for formoterol fumarate

Recent Clinical Trials for formoterol fumarate

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

Sponsor	Phase
Eurofarma Laboratorios S.A.	Phase 3
SGS S.A.	Phase 1
Université de Sherbrooke	N/A

See all formoterol fumarate clinical trials

Pharmacology for formoterol fumarate

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

Medical Subject Heading (MeSH) Categories for formoterol fumarate

Adrenergic beta-2 Receptor Agonists

Bronchodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for formoterol fumarate

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

Paragraph IV (Patent) Challenges for FORMOTEROL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PERFOROMIST	Inhalation Solution	formoterol fumarate	0.02 mg/2 mL	022007	1	2009-01-21

US Patents and Regulatory Information for 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	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	8,703,806
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	9,415,009
Lexenpharm	FORMOTEROL FUMARATE	formoterol fumarate	SOLUTION;INHALATION	216426-001	Oct 22, 2024	AN	RX	No	No
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	10,716,753		Y
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	8,815,258

Expired US Patents for formoterol fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	9,730,890
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	6,667,344
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	8,623,922
Novartis	FORADIL	formoterol fumarate	POWDER;INHALATION	020831-001	Feb 16, 2001	6,488,027
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	7,348,362
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	6,814,953

Formoterol fumarate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Formoterol Fumarate

Market Overview

The global formoterol fumarate market is experiencing significant growth, driven by several key factors. Rising pollution levels and the subsequent increase in respiratory issues such as asthma and chronic obstructive pulmonary disease (COPD) are major drivers. The market is segmented based on product forms, applications, and geographical regions, each contributing to its overall growth trajectory[1][4].

Market Size and Forecast

The formoterol fumarate market is projected to grow at a moderate pace, with substantial growth rates anticipated between 2023 and 2030. The market size is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent, reaching an estimated valuation of several billion USD by 2031[1][4].

Key Drivers

• Increasing Respiratory Issues: The rise in air pollution and other environmental factors has led to an increase in patients suffering from respiratory problems, such as asthma and COPD. This has created a significant demand for formoterol fumarate, a long-acting beta-agonist (LABA) used to treat these conditions[1].
• Lifestyle Factors: Poor dietary choices, lack of exercise, and smoking also contribute to the prevalence of respiratory diseases, further driving the demand for formoterol fumarate[1].
• Advancements in Treatment: The development of combination therapies, such as budesonide/formoterol fumarate and budesonide/glycopyrronium/formoterol fumarate, has improved treatment outcomes and adherence, boosting market growth[2][5].

Market Segmentation

By Product

The market is segmented into two main product forms:

• Powder: Available as an inhaler or dry powder, formoterol fumarate powder is a LABA bronchodilator used to treat asthma and COPD[1][4].
• Capsule: Also available in capsule form, this product offers an alternative delivery method for patients.

By Application

The primary applications are:

• Asthma: Formoterol fumarate is widely used to treat asthma, a disorder characterized by inflamed, constricted airways and excessive mucus production[1][4].
• Allergic Rhinitis: It is also used to treat allergic rhinitis, although this is a smaller segment compared to asthma.

By Geography

The market is geographically segmented into:

• North America: This region holds the largest share due to early adoption of asthma treatments and a high incidence of asthma, particularly in the United States[1][4].
• Europe: Europe is another significant market, driven by the presence of key players and high awareness of respiratory diseases.
• Asia Pacific: This region is expected to grow rapidly due to increasing awareness and improving healthcare infrastructure.
• Rest of the World: Other regions, including South America and the Middle East & Africa, also contribute to the market growth.

Financial Impact and Budgetary Analysis

The introduction of new formulations and combination therapies has significant financial implications. For instance, the introduction of DuoResp Spiromax (budesonide/formoterol fumarate) in Spain led to estimated budget savings of €6.01 million between 2015 and 2018. This was due to improved medication adherence and reduced healthcare resource use[3].

Competitive Landscape

The market is highly competitive, with several key players:

• Cipla Inc.
• Inke
• Fermion
• Beaukev Pharma International Pvt. Ltd.
• Astra Zeneca
• Mylan
• Nilkanth Organics
• BEVESPI
• GNH
• Hovione
• Aarti Industries

These companies are engaged in various strategies such as product innovation, market expansion, and partnerships to maintain their market share[1][4].

Regulatory and Approval Aspects

Formoterol fumarate, especially in combination therapies like Breztri Aerosphere (budesonide/glycopyrronium/formoterol fumarate), has undergone rigorous regulatory scrutiny. For example, the initial NDA for Breztri Aerosphere was met with a Complete Response action due to insufficient evidence of efficacy in a single phase 3 trial. However, such products continue to be approved and used in various delivery devices, indicating ongoing regulatory support for innovative treatments[5].

Economic Consequences and Cost Analysis

The economic impact of formoterol fumarate and its combination therapies is significant. Studies have shown that the use of these medications can lead to substantial cost savings by reducing the need for healthcare resources and improving patient outcomes. For instance, the total economic impact of treating COPD with budesonide/formoterol fumarate in Spain was estimated to be around €108 million to €121 million annually between 2015 and 2018, with savings observed when using newer formulations like DuoResp Spiromax[3].

Challenges and Restraints

Despite the growth, the market faces several challenges:

• Lack of Awareness: Limited awareness about respiratory diseases and their treatments hampers market growth.
• Skilled Professionals: The shortage of skilled healthcare professionals in some regions also restricts the market's potential[1].

Key Takeaways

• The formoterol fumarate market is driven by increasing respiratory issues and advancements in treatment options.
• The market is segmented by product form, application, and geography, with North America holding the largest share.
• Financial savings are significant with the introduction of new formulations and combination therapies.
• The competitive landscape is dominated by several key players focusing on innovation and market expansion.
• Regulatory approvals and cost analyses play crucial roles in the market's financial trajectory.

FAQs

Q: What are the primary drivers of the formoterol fumarate market? A: The primary drivers include increasing respiratory issues due to pollution, lifestyle factors, and advancements in treatment options.

Q: What are the main product forms of formoterol fumarate? A: The main product forms are powder and capsule.

Q: Which region holds the largest share of the formoterol fumarate market? A: North America holds the largest share due to early adoption of asthma treatments and a high incidence of asthma.

Q: What are the financial implications of introducing new formulations like DuoResp Spiromax? A: The introduction of new formulations can lead to significant budget savings by improving medication adherence and reducing healthcare resource use.

Q: Who are the key players in the formoterol fumarate market? A: Key players include Cipla Inc., Inke, Fermion, Beaukev Pharma International Pvt. Ltd., Astra Zeneca, Mylan, and others.

Cited Sources

1. Verified Market Research: Formoterol Fumarate Market Size, Share, Opportunities & Forecast.
2. Synapse: Budesonide/Formoterol fumarate/Glycopyrronium Bromide.
3. PMC: Estimating the economic consequences of an increased medication adherence.
4. Market Research Intellect: Formoterol Fumarate Market Size And Forecast.
5. FDA: Breztri Aerosphere (Budesonide/Glycopyrrolate/Formoterol Fumarate Inhalation Aerosol).