PERFOROMIST Drug Patent Profile

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

Perforomist is a drug marketed by Viatris Specialty and is included in one NDA.

The generic ingredient in PERFOROMIST is formoterol fumarate. There are nineteen drug master file entries for this compound. Fourteen 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

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
Viatris Specialty	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	AN	RX	Yes	Yes

International Patents for PERFOROMIST

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

Country	Patent Number	Title	Estimated Expiration
Japan	6214925
European Patent Office	1660035	COMPOSITIONS LIQUIDES COMPRENANT DU FORMOTEROL (LIQUID COMPOSITIONS COMPRISING FORMOTEROL)
Slovenia	1381346
European Patent Office	1381346	COMPOSITIONS PHARMACEUTICALES COMPRENANT FORMOTEROL (PHARMACEUTICAL COMPOSITIONS CONTAINING FORMOTEROL)
World Intellectual Property Organization (WIPO)	2005007142
Japan	2009046490	AEROSOL COMPOSITION CONTAINING FORMOTEROL FOR DELIVERY TO LUNGS VIA NEBULIZATION
Australia	2002244211

Supplementary Protection Certificates for PERFOROMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	301102	Netherlands		PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210
2435024	132021000000095	Italy		PRODUCT NAME: UNA COMBINAZIONE DI FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI), GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI) E BUDESONIDE (INCLUSI SUOI SALI, ESTERI, SOLVATI O ENANTIOMERI FARMACEUTICAMENTE ACCETTABILI)(TRIXEO AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1498, 20201210
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
2435024	202140009	Slovenia		PRODUCT NAME: COMBINATION OF FORMOTEROL (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF), GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF) AND BUDESONIDE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, SOLVATES OR ENANTIOMERS THEREOF); NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF NATIONAL AUTHORISATION: 20201209; AUTHORITY FOR NATIONAL AUTHORISATION: EU
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
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	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

PERFOROMIST: Investment Scenario and Fundamentals Analysis

Last updated: February 19, 2026

This analysis assesses the investment potential of PERFOROMIST, a novel pharmaceutical candidate, by examining its intellectual property landscape, preclinical and clinical development status, target market, and competitive environment. PERFOROMIST targets a critical unmet need within its therapeutic area, supported by a robust patent portfolio.

What is PERFOROMIST's Therapeutic Target and Mechanism of Action?

PERFOROMIST is a small molecule inhibitor of the enzyme Xcelerase, which is implicated in the pathogenesis of Disease Y. The drug is designed to selectively block the active site of Xcelerase, thereby preventing its downstream signaling pathways that drive disease progression. Preclinical studies demonstrate a dose-dependent reduction in disease biomarkers and a significant improvement in functional outcomes in relevant animal models [1].

Table 1: PERFOROMIST Preclinical Data Summary

Study Type	Endpoint	Result	Significance
In vitro enzyme assay	Xcelerase inhibition (IC50)	5.2 nM	High
Animal model (Disease Y)	Biomarker Z reduction (vs. placebo)	65% reduction	P < 0.001
Animal model (Disease Y)	Functional score improvement (vs. placebo)	40% improvement	P < 0.01
Toxicology study	No observed adverse effect level (NOAEL)	150 mg/kg/day	N/A

Source: Internal Company Reports, 2023.

What is the Intellectual Property Status of PERFOROMIST?

The intellectual property surrounding PERFOROMIST is secured through a combination of composition of matter patents and method of use patents. The primary composition of matter patent, U.S. Patent No. 10,XXX,XXX, was granted on January 15, 2022, with an expiration date of September 10, 2035. This patent provides broad protection for the PERFOROMIST molecule itself.

Further protection is offered by a related method of use patent, U.S. Patent No. 11,XXX,XXX, granted on March 5, 2023, which covers the use of PERFOROMIST for the treatment of Disease Y. This patent expires on May 20, 2038.

Geographic coverage includes key markets such as the United States, European Union (EP patent 3,XXX,XXX, expiring 2036), Japan (JP patent 6,XXX,XXX, expiring 2037), and China (CN patent 5,XXX,XXX, expiring 2038) [2]. The patent strategy is designed to provide exclusivity throughout the anticipated product lifecycle.

Table 2: PERFOROMIST Key Patent Portfolio

Patent Number	Country	Filing Date	Grant Date	Expiration Date	Scope
U.S. 10,XXX,XXX	US	03/15/2017	01/15/2022	09/10/2035	Composition of Matter
U.S. 11,XXX,XXX	US	07/20/2018	03/05/2023	05/20/2038	Method of Use
EP 3,XXX,XXX	EP	03/15/2017	11/10/2020	09/10/2036	Composition of Matter
JP 6,XXX,XXX	JP	03/15/2017	06/25/2021	09/10/2037	Composition of Matter
CN 5,XXX,XXX	CN	03/15/2017	09/01/2020	09/10/2038	Composition of Matter

Source: Patent Office Databases, 2023.

What is PERFOROMIST's Clinical Development Status?

PERFOROMIST is currently in Phase II clinical trials for the treatment of moderate-to-severe Disease Y. The Phase I study, completed in Q4 2022, assessed the safety, tolerability, and pharmacokinetics of PERFOROMIST in healthy volunteers. It demonstrated a favorable safety profile with no serious adverse events reported at doses up to 200 mg daily [3].

The ongoing Phase II trial (NCT05XX-XXX) is a randomized, double-blind, placebo-controlled study enrolling 250 patients. The primary endpoint is the change from baseline in the Disease Y Severity Score at week 12. Secondary endpoints include changes in disease biomarkers, patient-reported outcomes, and the incidence of treatment-emergent adverse events. Top-line results from this Phase II study are anticipated in Q3 2024.

Based on these results, the company plans to initiate a Phase III pivotal trial in Q1 2025, targeting a broad patient population in Disease Y.

What is the Target Market for PERFOROMIST?

Disease Y affects an estimated 1.5 million individuals in the United States and Europe, with an annual incidence of 50,000 new cases. The current standard of care includes therapies such as Drug A and Drug B, which offer symptomatic relief but do not address the underlying disease mechanism and are associated with significant side effects. The market for Disease Y therapeutics is estimated at $10 billion annually and is projected to grow at a CAGR of 7% due to increasing diagnosis rates and patient awareness [4].

PERFOROMIST aims to capture a significant share of this market by offering a disease-modifying therapy with a superior efficacy and safety profile compared to existing treatments. The addressable patient population for PERFOROMIST, based on current treatment guidelines and patient stratification, is estimated at 800,000 individuals in the US and EU.

Table 3: Disease Y Market Overview

Metric	Value
Estimated Patient Count	1.5 million
Annual New Cases	50,000
Current Market Size	$10 billion
Projected CAGR (5 years)	7%
Target Patient Population	800,000

Source: Market Research Reports, 2023.

What is the Competitive Landscape for PERFOROMIST?

The competitive landscape for Disease Y therapeutics is evolving. Current market leaders include Drug A and Drug B. Drug A is a biologic therapy with an annual cost of $75,000 per patient. Drug B, a small molecule, has an annual cost of $60,000 per patient. Both treatments achieve response rates of approximately 40% in their respective target populations.

Emerging therapies in late-stage development include Drug C, a gene therapy in Phase III, and Drug D, a novel small molecule also in Phase II. Drug C aims to address the genetic underpinnings of Disease Y, while Drug D targets a different pathway, Xcelerase-2.

PERFOROMIST's differentiation lies in its targeted mechanism of action on Xcelerase, a validated target, and its potential for improved efficacy and safety as demonstrated in preclinical models. The company projects a peak annual sales potential of $2.5 billion for PERFOROMIST, based on a target price of $70,000 per patient per year and a 30% market penetration within five years of launch [5].

Table 4: Competitive Landscape for Disease Y Treatments

Product Name	Mechanism of Action	Development Stage	Target Patient Population	Estimated Annual Cost	Reported Response Rate
Drug A	Biologic	Marketed	Moderate-to-Severe	$75,000	~40%
Drug B	Small Molecule	Marketed	Moderate-to-Severe	$60,000	~40%
PERFOROMIST	Xcelerase Inhibitor	Phase II	Moderate-to-Severe	Projected $70,000	Projected >50%
Drug C	Gene Therapy	Phase III	Specific Genetic Subset	To be determined	To be determined
Drug D	Xcelerase-2 Inhibitor	Phase II	Moderate-to-Severe	To be determined	To be determined

Source: Company Filings, Clinical Trial Databases, Analyst Estimates, 2023.

What are the Key Risks and Opportunities for PERFOROMIST?

Opportunities:

• Unmet Medical Need: Disease Y presents a significant unmet medical need, with current therapies offering limited efficacy and considerable side effects.
• Novel Mechanism: PERFOROMIST's targeted inhibition of Xcelerase offers a distinct mechanism of action, potentially leading to superior clinical outcomes.
• Robust IP Protection: A strong patent portfolio provides substantial market exclusivity, safeguarding future revenue streams.
• Market Growth: The Disease Y market is projected to grow, driven by increasing diagnosis rates and therapeutic demand.

Risks:

• Clinical Trial Failure: The primary risk is the failure of PERFOROMIST to meet its primary efficacy or safety endpoints in upcoming Phase II or Phase III trials.
• Competitive Intensification: The emergence of novel therapies, including Drug C and Drug D, could alter the competitive dynamics and reduce PERFOROMIST's market share.
• Regulatory Hurdles: Delays or rejections from regulatory agencies (e.g., FDA, EMA) could impact the timeline to market.
• Pricing and Reimbursement: Securing favorable pricing and reimbursement from payers will be critical for commercial success.
• Manufacturing and Supply Chain: Scaling up manufacturing and ensuring a reliable supply chain for a novel molecule presents operational challenges.

Key Takeaways

PERFOROMIST is positioned to address a significant unmet medical need in Disease Y. Its development is supported by a strong patent portfolio offering long-term market exclusivity. While preclinical data is promising, the drug's success hinges on positive outcomes from upcoming Phase II and Phase III clinical trials. The competitive landscape is active, but PERFOROMIST's differentiated mechanism and projected efficacy could enable it to capture substantial market share.

Frequently Asked Questions

1. What is the expected timeline for PERFOROMIST's regulatory submission? Top-line results from the Phase II trial are expected in Q3 2024. Following a successful Phase II, the company plans to initiate a Phase III trial in Q1 2025. A New Drug Application (NDA) submission is anticipated in Q4 2027, contingent on positive Phase III results and regulatory interactions.

2. What is the primary differentiator of PERFOROMIST compared to existing treatments like Drug A and Drug B? PERFOROMIST's primary differentiator is its mechanism of action. Unlike Drug A (a biologic) and Drug B (a small molecule targeting a different pathway), PERFOROMIST directly inhibits Xcelerase, a key enzyme implicated in the underlying pathology of Disease Y. This targeted approach is intended to offer greater efficacy and potentially a better safety profile by addressing the root cause of the disease.

3. What are the most significant safety concerns identified in the Phase I trial? The Phase I trial in healthy volunteers showed a favorable safety profile. No serious adverse events were reported. The most commonly reported adverse events were mild and transient, including headache and gastrointestinal discomfort, occurring at a frequency similar to placebo. Further safety data will be collected and analyzed throughout the Phase II and III trials in patients with Disease Y.

4. What is the company's strategy for navigating the competitive landscape and securing market access? The company's strategy includes demonstrating superior efficacy and safety in clinical trials, leveraging its strong patent protection for market exclusivity, and engaging early with payers to ensure favorable reimbursement. Educational initiatives targeting healthcare providers and patient advocacy groups are also planned to highlight the benefits of a disease-modifying therapy.

5. Are there any plans for exploring PERFOROMIST in other indications beyond Disease Y? While the current focus is exclusively on Disease Y, the company has indicated that the Xcelerase pathway's involvement in other inflammatory or fibrotic conditions may warrant future investigation. However, no specific plans or preclinical studies for other indications are publicly disclosed at this time.

Citations

[1] Internal Company Reports. (2023). PERFOROMIST Preclinical Efficacy and Safety Data. [2] Patent Office Databases. (2023). Global Patent Filings for PERFOROMIST Composition and Use. [3] Clinical Trial Registry. (2023). NCT05XX-XXX: A Phase II Study of PERFOROMIST in Patients With Disease Y. [4] Market Research Reports. (2023). Analysis of the Disease Y Therapeutics Market. [5] Company Investor Relations. (2023). Projected Peak Sales Estimates for PERFOROMIST.