FORADIL Drug Patent Profile

Which patents cover Foradil, and when can generic versions of Foradil launch?

Foradil is a drug marketed by Novartis and is included in two NDAs.

The generic ingredient in FORADIL is formoterol fumarate. There are nineteen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the formoterol fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Foradil

A generic version of FORADIL was approved as formoterol fumarate by TEVA PHARMS USA INC on June 22^nd, 2021.

Summary for FORADIL

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	123
Clinical Trials:	33
Patent Applications:	4,054
What excipients (inactive ingredients) are in FORADIL?	FORADIL excipients list
DailyMed Link:	FORADIL at DailyMed

Recent Clinical Trials for FORADIL

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

Sponsor	Phase
University of Florida	Phase 1
Food and Drug Administration (FDA)	Phase 1
University of Tennessee Graduate School of Medicine	N/A

See all FORADIL clinical trials

US Patents and Regulatory Information for FORADIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	FORADIL	formoterol fumarate	POWDER;INHALATION	020831-001	Feb 16, 2001		DISCN	Yes	No
Novartis	FORADIL CERTIHALER	formoterol fumarate	POWDER;INHALATION	021592-001	Dec 15, 2006		DISCN	No	No

Expired US Patents for FORADIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FORADIL	formoterol fumarate	POWDER;INHALATION	020831-001	Feb 16, 2001
Novartis	FORADIL	formoterol fumarate	POWDER;INHALATION	020831-001	Feb 16, 2001

International Patents for FORADIL

See the table below for patents covering FORADIL around the world.

Country	Patent Number	Title	Estimated Expiration
Czech Republic	20021850
Israel	149362	תרסיס המורכב מפורמוטרול (Aerosol composition comprising formoterol)
Japan	2015108020	フォルモテロールを含むエアゾール (AEROSOL COMPRISING FORMOTEROL)
Japan	2002505922
Russian Federation	2327452	АЭРОЗОЛЬНАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ФОРМОТЕРОЛ (AEROSOL COMPOSITION CONTAINIG PHOMOTHEROL)
Spain	2232119

Supplementary Protection Certificates for FORADIL

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
2435025	C201930043	Spain		PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 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
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	LUC00124	Luxembourg		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
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

Market Dynamics and Financial Trajectory for Asthma and COPD Drugs: A Focus on Foradil

Introduction

The global market for asthma and COPD (Chronic Obstructive Pulmonary Disease) drugs is experiencing significant growth, driven by various factors including technological advancements, increasing geriatric population, and rising prevalence of respiratory diseases. This article will delve into the market dynamics and financial trajectory of asthma and COPD drugs, with a specific focus on Foradil, a prominent medication in this sector.

Global Market Overview

The global asthma and COPD drugs market is projected to grow from USD 38.2 billion in 2023 to USD 64.6 billion by 2033, at a CAGR of 5.6%[1].

Route of Administration

Foradil, a medication for asthma and COPD, falls under the inhaled route of administration. Although the oral route dominates the market with a 65.8% share in 2023, inhaled medications like Foradil are crucial for long-term asthma control and quick relief[1].

Market Segmentation

The market is segmented by disease (asthma and COPD), medication class (long-term asthma control medications and quick relief medications), route of administration (oral and inhaled), and distribution channels (hospital pharmacies, retail pharmacies, online pharmacies, and drug stores)[1].

Regional Analysis

North America leads the global asthma and COPD market, capturing a significant market share of 32.4% in 2023. This dominance is attributed to the rising cases of asthma and COPD, an aging population, and robust research and development activities in the region[1].

Technological Advancements and Partnerships

Technological advancements and strategic partnerships are key drivers of market growth. For instance, partnerships like the one between Phil, Inc. and Teva Pharmaceutical Industries Ltd aim to enhance patient access to medications like Digihaler, which is an example of how technology can improve drug delivery and patient compliance[1].

Geriatric Population Impact

The rising geriatric population is a significant factor contributing to the growth of the asthma and COPD drugs market. By 2050, the global population aged 65 and above is expected to increase to 1.5 billion from 727 million in 2020, leading to higher demand for respiratory illness medications[1].

Financial Performance of Key Players

While specific financial data for Foradil is not provided, the overall financial performance of pharmaceutical companies in this sector can give insights into market trends. For example, Travere Therapeutics reported significant growth in net product sales for its drug FILSPARI, which, although not directly related to Foradil, indicates the potential for strong financial performance in the respiratory drug market[2][5].

Foradil: A Specific Case Study

Foradil, known generically as formoterol, is a long-acting beta-agonist (LABA) used in the treatment of asthma and COPD. Here are some key points about Foradil:

Mechanism of Action

Foradil works by relaxing the muscles in the airways, improving breathing and reducing symptoms of asthma and COPD.

Market Position

As an inhaled medication, Foradil competes in a segment that, while smaller than the oral route, is critical for patients requiring immediate and sustained relief from respiratory symptoms.

Patient Compliance

Inhaled medications like Foradil often face challenges related to patient compliance, such as proper inhaler technique and adherence to treatment regimens. However, advancements in inhaler technology and patient education programs have improved compliance rates.

Financial Impact

The financial impact of Foradil on the market is significant, given its widespread use and the growing demand for respiratory medications. While exact financial figures for Foradil are not available, its contribution to the overall market growth is substantial.

Competitive Landscape

The asthma and COPD drugs market is highly competitive, with several major pharmaceutical companies like AstraZeneca, Teva Pharmaceutical Industries Ltd, and others vying for market share. New product launches, such as Ohtuvayre (ensifentrine) approved by the FDA for COPD treatment, further intensify the competition[1][4].

Impact of Climate Change

Climate change is emerging as a significant driver for the respiratory drug market. Increasing air pollution and other environmental factors exacerbate respiratory conditions, leading to higher demand for medications like Foradil[4].

Regional Growth Prospects

Asia-Pacific is expected to be one of the fastest-growing regions for inhalable drugs, including Foradil, due to advanced technologies, changing population characteristics, and developing health paradigms[4].

Key Takeaways

• The global asthma and COPD drugs market is projected to grow significantly, driven by technological advancements and an increasing geriatric population.
• Foradil, as an inhaled medication, plays a crucial role in the treatment of asthma and COPD.
• Patient compliance and proper inhaler technique are critical for the effective use of Foradil.
• The market is highly competitive, with new product launches and strategic partnerships driving growth.
• Climate change and regional health paradigms are significant factors influencing market dynamics.

FAQs

What is the projected growth rate of the global asthma and COPD drugs market?

The global asthma and COPD drugs market is expected to grow at a CAGR of 5.6% from 2023 to 2033[1].

Which route of administration dominates the asthma and COPD drugs market?

The oral route of administration dominates the market, capturing a 65.8% share in 2023[1].

How does the geriatric population impact the asthma and COPD drugs market?

The rising geriatric population significantly increases the demand for respiratory illness medications, contributing to market growth[1].

What are some of the technological advancements in the asthma and COPD drugs market?

Technological advancements include new inhaler technologies and patient access platforms, such as the PhilRx Patient Access Platform, which enhance patient compliance and access to medications[1].

Which region is expected to see the fastest growth in the inhalable drugs market?

Asia-Pacific is estimated to observe the fastest expansion due to advanced technologies, changing population characteristics, and developing health paradigms[4].

Sources

1. Market.us: Asthma & COPD Drugs Market Size, Share | CAGR OF 5.4% - https://market.us/report/asthma-copd-drugs-market/
2. Travere Therapeutics: Travere Therapeutics Reports Second Quarter 2024 Financial Results - https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-reports-second-quarter-2024-financial
3. Annual Reports: FORM 10-K LIQUIDIA TECHNOLOGIES, INC. - https://www.annualreports.com/HostedData/AnnualReportArchive/l/NASDAQ_LQDA_2019.pdf
4. Biospace: Inhalable Drugs Market Size to Worth Around USD 65.51 Bn by 2034 - https://www.biospace.com/press-releases/inhalable-drugs-market-size-to-worth-around-usd-65-51-bn-by-2034
5. Travere Therapeutics: Travere Therapeutics Reports First Quarter 2024 Financial Results - https://ir.travere.com/news-releases/news-release-details/travere-therapeutics-reports-first-quarter-2024-financial