PERFOROMIST Drug Patent Profile

When do Perforomist patents expire, and when can generic versions of Perforomist launch?

Perforomist is a drug marketed by Mylan Speclt and is included in one NDA.

The generic ingredient in PERFOROMIST 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 Perforomist

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

Summary for PERFOROMIST

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	6
Patent Applications:	4,438
Drug Prices:	Drug price information for PERFOROMIST
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PERFOROMIST
What excipients (inactive ingredients) are in PERFOROMIST?	PERFOROMIST excipients list
DailyMed Link:	PERFOROMIST at DailyMed

See drug prices for PERFOROMIST

Recent Clinical Trials for PERFOROMIST

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

Sponsor	Phase
Mylan Inc.	Phase 3
Theravance Biopharma	Phase 3
Chiesi Farmaceutici S.p.A.	Phase 2

See all PERFOROMIST clinical trials

Pharmacology for PERFOROMIST

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

Paragraph IV (Patent) Challenges for PERFOROMIST

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 PERFOROMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	AN	RX	Yes	Yes

Expired US Patents for PERFOROMIST

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	8,623,922
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	9,730,890
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	7,462,645
Mylan Speclt	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	7,348,362

International Patents for PERFOROMIST

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	02083079
European Patent Office	1381346	COMPOSITIONS PHARMACEUTICALES COMPRENANT FORMOTEROL (PHARMACEUTICAL COMPOSITIONS CONTAINING FORMOTEROL)
Slovenia	1381346
Australia	2002244211
Japan	2004532217

Supplementary Protection Certificates for PERFOROMIST

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

PERFOROMIST Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PERFOROMIST

Introduction to PERFOROMIST

PERFOROMIST, also known as formoterol fumarate inhalation solution, is a long-acting beta2 adrenergic agonist (LABA) used to control the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults. It is administered via a nebulizer and is indicated for the treatment of bronchoconstriction in patients with COPD, including those with chronic bronchitis and emphysema[1].

Market Demand and Drivers

The demand for PERFOROMIST is driven by several key factors:

Rising Prevalence of COPD

The increasing prevalence of COPD, exacerbated by rising pollution levels, poor air quality, and lifestyle factors such as smoking and lack of exercise, contributes significantly to the demand for formoterol fumarate inhalation solutions. COPD is a chronic lung disease that includes chronic bronchitis and emphysema, and its symptoms can be severe and debilitating[4].

Geographical Distribution

The global formoterol fumarate market is segmented geographically, with North America holding the largest share due to the early adoption of asthma and COPD treatments in this region. The United States is a significant market within North America, driven by the high incidence of asthma and COPD[4].

Financial Performance and Sales

Annual Sales

The branded version of PERFOROMIST has significant annual sales, exceeding $299 million in the U.S. as of March 2021, according to IQVIA data. This figure underscores the market's substantial demand for this medication[1].

Generic Market Entry

The launch of the first generic version of PERFOROMIST by Teva Pharmaceuticals marked a significant event in the market. This generic version is expected to increase accessibility and affordability for patients, potentially expanding the market share. Teva's extensive portfolio of generic medicines and its leading position in first-to-file opportunities further solidify its market presence[1].

Competitive Landscape

The respiratory market, particularly the long-acting nebulized (LA-NEB) segment, is competitive and includes several key players and products such as YUPELRI, BROVANA, LONHALA, and arformoterol. PERFOROMIST competes in this space, and its market share is influenced by factors such as product differentiation, pricing, and the strength of the manufacturer's distribution network[3].

Strategic Collaborations and Innovations

Companies like Viatris and Theravance Biopharma are involved in strategic collaborations and innovations that impact the market dynamics of respiratory medications. For instance, Viatris's focus on expanding its innovative portfolio includes collaborations for the development and commercialization of new assets, which can influence the competitive landscape and future market trends[2][3].

Regulatory and Market Trends

Regulatory Environment

The regulatory environment plays a crucial role in the market trajectory of PERFOROMIST. Approvals, label updates, and patent protections are key factors that can affect market share and revenue. For example, the PIFR clinical study aimed at supporting a label update for YUPELRI to capture more of the addressable market highlights the importance of regulatory strategies in this sector[3].

Market Trends

The global formoterol fumarate market is expected to grow significantly from 2023 to 2030, driven by increasing awareness of respiratory diseases and the need for effective treatments. The market is also influenced by trends such as the rise in pollution levels, lifestyle changes, and the growing demand for inhalation solutions[4].

Financial Trajectory of Key Players

Teva Pharmaceuticals

Teva's financial trajectory is influenced by its extensive portfolio of generic medicines, including the launch of the generic version of PERFOROMIST. With over 500 generic medicines available, Teva holds a leading position in the generics market, and its financial performance is robust, with a significant portion of generic prescriptions in the U.S. filled with Teva products[1].

Viatris

Viatris, formed by the combination of Mylan N.V. and the Upjohn business of Pfizer Inc., has a strong financial foundation. In 2023, Viatris reported total revenues of $15.4 billion, adjusted EBITDA of $5.1 billion, and free cash flow of $2.4 billion. The company's focus on debt reduction, returning capital to shareholders, and expanding its innovative portfolio positions it for future growth[2].

Challenges and Risks

Market Competition

The market for respiratory medications is highly competitive, with multiple players and products. This competition can impact pricing, market share, and the commercial success of PERFOROMIST and its generic versions[1][3].

Regulatory Risks

Regulatory risks, including delays in approvals and changes in regulatory requirements, can significantly affect the market trajectory of PERFOROMIST. Additionally, the effectiveness of patents and other intellectual property measures is crucial in protecting market share[1].

Global Health Pandemics

Global health pandemics, such as COVID-19, can impact the business operations and financial performance of pharmaceutical companies, including those manufacturing and distributing PERFOROMIST[3].

Key Takeaways

• Market Demand: Driven by the rising prevalence of COPD and poor air quality.
• Financial Performance: Significant annual sales, with the branded version exceeding $299 million in the U.S.
• Generic Market Entry: Teva's launch of the first generic version of PERFOROMIST increases accessibility and affordability.
• Competitive Landscape: Highly competitive LA-NEB market with multiple key players.
• Regulatory and Market Trends: Influenced by regulatory approvals, label updates, and market trends such as increasing awareness of respiratory diseases.
• Financial Trajectory of Key Players: Strong financial performance by Teva and Viatris, with a focus on debt reduction, shareholder returns, and innovative portfolio expansion.

FAQs

1. What is PERFOROMIST used for?

PERFOROMIST (formoterol fumarate inhalation solution) is used to control the symptoms of Chronic Obstructive Pulmonary Disease (COPD) in adults, including chronic bronchitis and emphysema.

2. Who launched the first generic version of PERFOROMIST?

Teva Pharmaceuticals launched the first generic version of PERFOROMIST in the United States.

3. What are the key drivers of the formoterol fumarate market?

The key drivers include the rising prevalence of COPD, poor air quality, lifestyle factors, and increasing awareness of respiratory diseases.

4. How does the competitive landscape affect PERFOROMIST?

The competitive landscape, including other LA-NEB products like YUPELRI and BROVANA, influences pricing, market share, and commercial success.

5. What are the financial highlights of Viatris relevant to the respiratory market?

Viatris reported total revenues of $15.4 billion, adjusted EBITDA of $5.1 billion, and free cash flow of $2.4 billion in 2023, with a focus on debt reduction and expanding its innovative portfolio.

Cited Sources

1. Teva Announces Its Launch of the First Generic PERFOROMIST - Teva Pharmaceuticals.
2. 2023 Annual Report - Viatris Investor Relations.
3. TBPH Q3 2021 Financial Results and Business Update - Theravance Biopharma.
4. Formoterol Fumarate Market Size, Share, Opportunities & Forecast - Verified Market Research.