FORADIL CERTIHALER Drug Patent Profile

When do Foradil Certihaler patents expire, and what generic alternatives are available?

Foradil Certihaler is a drug marketed by Novartis and is included in one NDA.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Foradil Certihaler

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

Summary for FORADIL CERTIHALER

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	36
Patent Applications:	1,107
DailyMed Link:	FORADIL CERTIHALER at DailyMed

US Patents and Regulatory Information for FORADIL CERTIHALER

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

Expired US Patents for FORADIL CERTIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	FORADIL CERTIHALER	formoterol fumarate	POWDER;INHALATION	021592-001	Dec 15, 2006	6,182,655
Novartis	FORADIL CERTIHALER	formoterol fumarate	POWDER;INHALATION	021592-001	Dec 15, 2006	6,645,466

International Patents for FORADIL CERTIHALER

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	0995457	Embout buccal pour un inhalateur fournissant des doses multiples d'une poudre sèche pharmacologique (Mouthpiece for an inhalator designed to provide multiple doses of dry pharmacological powder)
World Intellectual Property Organization (WIPO)	0028979
Portugal	1131059
Slovakia	284889
Australia	7617396
Japan	3669710

Supplementary Protection Certificates for FORADIL CERTIHALER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2019014,C2435025	Lithuania		PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
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
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	CR 2019 00032	Denmark		PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER SOLVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERE ELLER SOLVATER DERAF; REG. NO/DATE: 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

FORADIL CERTIHALER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Foradil Certihaler

Introduction

Foradil Certihaler, a breath-actuated multi-dose dry powder inhaler containing formoterol fumarate, was developed through a collaborative effort between Novartis and SkyePharma. Here, we delve into the market dynamics and financial trajectory of this drug.

Development and Approval

Foradil Certihaler was the result of an agreement signed in November 1998 between Novartis Pharma and SkyePharma PLC to develop a new formulation of the beta(2)-adrenoceptor agonist formoterol. The product utilized SkyePharma's SkyeProtect powder formulation technology and the SkyeHaler inhalation device. It received its first approval in Europe in March 2004, specifically in Switzerland, triggering an undisclosed milestone payment from Novartis to SkyePharma[1].

Clinical Trials and Regulatory Submissions

Clinical trials for Foradil Certihaler began in October 1999, with phase III trials commencing in Europe in December 2000 and in the US in April 2001. Regulatory submissions were filed in the EU and the US in December 2002, and the US FDA issued an 'approvable' letter in October 2003[1].

Market Launch and Expectations

The launch of Foradil Certihaler was anticipated for 2004. SkyePharma estimated the worldwide sales potential of Foradil Certihaler to be as high as $600 million, with the company anticipating significant royalties and manufacturing revenues[1].

Market Performance and Financial Impact

Despite the initial optimism, the commercialization of Foradil Certihaler faced challenges. The decision not to proceed with US commercialization led to the termination of contracts between Novartis and SkyePharma in July 2009. This termination resulted in an exceptional income of £5.1 million for SkyePharma, which was a net cash inflow[2].

Revenue and Royalties

SkyePharma was set to receive royalties and manufacturing revenues from the sales of Foradil Certihaler. However, the failure to commercialize the product in the US significantly impacted these revenue streams. The company's overall revenue for 2009 was £55.9 million, down 10% from the previous year, partly due to lower milestones and non-recurring manufacturing revenues[2].

Operating Profit and EBITDA

Despite the challenges, SkyePharma reported an improvement in pre-exceptional operating profit, up 39% to £15.1 million in 2009, driven by lower research and development expenses, cost savings, and price increases for manufactured products. The pre-exceptional EBITDA also increased by 14.1% to £18.6 million[2].

Market Dynamics in the Respiratory Drugs Sector

The respiratory drugs market, which includes products like Foradil Certihaler, is driven by several key factors:

Increasing Prevalence of Respiratory Disorders

The market is significantly influenced by the increasing prevalence of respiratory disorders such as asthma and chronic obstructive pulmonary disease (COPD). These conditions drive the demand for inhalation-based therapies and advanced treatments[3].

Advancements in Drug Delivery Technologies

Technological advancements, such as the use of dry powder inhalers like the SkyeHaler device, play a crucial role in the market. These technologies improve the efficacy and convenience of drug delivery, making them more appealing to patients and healthcare providers[3].

Regulatory and Safety Considerations

Safety concerns and side effects associated with long-term use of respiratory drugs can hinder their adoption. Additionally, high costs of advanced therapies and regulatory hurdles can limit market expansion[3].

Regional Market Analysis

North America

North America, particularly the US, dominates the respiratory drugs market due to advanced healthcare infrastructure, strong R&D activities, and the widespread adoption of combination therapies. However, the high costs of novel therapies and regulatory challenges can limit growth in this region[3].

Asia Pacific

The Asia Pacific region is experiencing the fastest growth, driven by rising pollution levels, increasing prevalence of smoking, and growing awareness of respiratory health. Countries like China, India, and Japan are major contributors to this growth, although challenges such as limited access to advanced therapies in rural areas persist[3].

Key Takeaways

• Approval and Launch: Foradil Certihaler received its first European approval in Switzerland in 2004 but faced challenges in US commercialization.
• Financial Impact: The termination of US commercialization contracts resulted in significant financial adjustments for SkyePharma, including a one-time exceptional income.
• Market Dynamics: The respiratory drugs market is driven by increasing prevalence of respiratory disorders, advancements in drug delivery technologies, and regional healthcare infrastructure.
• Regional Performance: North America and the Asia Pacific region are key markets, with different challenges and opportunities in each.

FAQs

What is Foradil Certihaler?

Foradil Certihaler is a breath-actuated multi-dose dry powder inhaler containing formoterol fumarate, used for the treatment of asthma and prevention of bronchospasm.

Who developed Foradil Certihaler?

Foradil Certihaler was developed through a collaboration between Novartis and SkyePharma.

What were the initial sales expectations for Foradil Certihaler?

SkyePharma estimated the worldwide sales potential of Foradil Certihaler to be as high as $600 million.

Why was the US commercialization of Foradil Certihaler terminated?

The decision to terminate US commercialization was made after the product received an 'approvable' letter from the US FDA but did not proceed to full approval and commercial launch.

How did the termination of US commercialization affect SkyePharma financially?

The termination resulted in an exceptional income of £5.1 million for SkyePharma, which was a net cash inflow, but overall impacted the company's revenue and royalty streams negatively.

Sources

1. PubMed: Formoterol dry-powder inhalation--Novartis/SkyePharma: Foradil Certihaler.
2. London Stock Exchange: Preliminary statement of annual results SkyePharma PLC.
3. Consegic Business Intelligence: Respiratory Drugs Market Size, Trends, Growth, Report 2031.