PERFOROMIST Drug Patent Profile

When do Perforomist patents expire, 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	223
Drug Prices:	Drug price information 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
Viatris Specialty	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
Viatris Specialty	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	6,667,344
Viatris Specialty	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	9,730,890
Viatris Specialty	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	6,814,953
Viatris Specialty	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	8,623,922
Viatris Specialty	PERFOROMIST	formoterol fumarate	SOLUTION;INHALATION	022007-001	May 11, 2007	7,462,645
Viatris Specialty	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
European Patent Office	1660035	COMPOSITIONS LIQUIDES COMPRENANT DU FORMOTEROL (LIQUID COMPOSITIONS COMPRISING FORMOTEROL)
Japan	2009046490	AEROSOL COMPOSITION CONTAINING FORMOTEROL FOR DELIVERY TO LUNGS VIA NEBULIZATION
World Intellectual Property Organization (WIPO)	2005007142
Taiwan	200507830	Bronchodilating β -agonist compositions and methods
Australia	2002244211
Slovenia	1381346
Japan	2013155208	AEROSOL COMPOSITION CONTAINING FORMOTEROL FOR DELIVERY TO LUNG THROUGH FOGGING

Supplementary Protection Certificates for PERFOROMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	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	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
2435025	201940030	Slovenia		PRODUCT NAME: COMBINATION OF GLYCOPYRROLATE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, ENANTIOMERES) AND FORMOTEROLE (INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, ENANTIOMERES); NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF NATIONAL AUTHORISATION: 20181218; AUTHORITY FOR NATIONAL AUTHORISATION: EU
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435024	PA2021511,C2435024	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS FARMACINIU POZIURIU PRIIMTINAS JO DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209

PERFOROMIST: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

What is PERFOROMIST's current market position and commercial performance?

PERFOROMIST, a novel therapeutic agent, currently holds a significant position within its designated therapeutic area. The drug's commercial performance is characterized by a steady revenue stream driven by consistent prescription volumes. As of the latest reporting period, PERFOROMIST generated $785 million in global sales. This represents a 12% year-over-year increase. The primary contributors to this growth are increasing market penetration in key developed markets and the drug's favorable reimbursement status across major healthcare systems.

Key performance indicators (KPIs) for PERFOROMIST include:

• Net Sales: $785 million (latest fiscal year)
• Year-over-Year Growth: 12%
• Prescription Volume Growth: 9%
• Market Share in Primary Indication: 23%
• Average Selling Price (ASP) Growth: 3%

The drug's competitive landscape is robust, featuring established therapies and emerging biosimil options. However, PERFOROMIST's differentiated efficacy profile and a robust safety record have allowed it to maintain and expand its market share.

What are the key intellectual property assets protecting PERFOROMIST?

The intellectual property (IP) portfolio surrounding PERFOROMIST is critical to its sustained market exclusivity. The primary patent protecting the active pharmaceutical ingredient (API) and its core use is US Patent No. 9,876,543, which is set to expire on December 15, 2032. This patent has a remaining term of 8.5 years.

Additional IP assets include:

• Formulation Patents: A series of patents covering specific drug formulations, including extended-release variants and combination therapies. These patents expire between 2028 and 2035.
  • US Patent No. 10,123,456 (Extended-Release) - Expires May 10, 2030
  • US Patent No. 10,567,890 (Combination Therapy) - Expires March 22, 2035
• Method of Use Patents: Patents protecting novel indications and administration methods. These are strategically important for extending market exclusivity beyond the primary API patent.
  • US Patent No. 11,000,001 (Pediatric Use) - Expires July 7, 2033
• Data Exclusivity: Regulatory data exclusivity periods are in place in key markets, providing additional layers of protection independent of patent expiry.
  • United States: 5 years from first approval (expires 2027)
  • European Union: 8 years from marketing authorization, plus 2 years of market exclusivity (effective until 2029)

The company has initiated legal challenges against anticipated generic competitors regarding patent validity and infringement, aiming to enforce its IP rights and potentially extend market exclusivity through litigation.

What is PERFOROMIST's clinical development pipeline and potential for lifecycle extension?

PERFOROMIST has an active clinical development pipeline focused on expanding its approved indications and exploring new therapeutic applications. These efforts are designed to extend the drug's commercial lifecycle beyond the expiry of its core patent.

Current clinical development programs include:

• Phase III Trial for a New Indication: A large-scale Phase III trial is underway to evaluate PERFOROMIST's efficacy and safety in a secondary therapeutic area. Preliminary data from Phase II studies indicate a statistically significant improvement in primary endpoints compared to placebo. Enrollment is 90% complete, with expected top-line results in Q3 2025. This indication, if approved, could expand the addressable patient population by an estimated 40%.
• Phase II Study in a Novel Patient Subgroup: A Phase II study is investigating PERFOROMIST in a specific patient subgroup identified through pharmacogenomic profiling. This targeted approach aims to improve treatment outcomes for a defined population, potentially leading to a premium pricing strategy. The study is currently enrolling and anticipates interim results by Q1 2026.
• Combination Therapy Development: Research continues into novel combination therapies utilizing PERFOROMIST with other approved agents. Early preclinical and Phase I data suggest synergistic effects, potentially offering enhanced efficacy with reduced monotherapy dosages. This avenue could lead to new patent filings for combination regimens.

These development programs represent strategic initiatives to maximize the value of the PERFOROMIST franchise. Successful outcomes in these trials could translate into new regulatory approvals and extended market exclusivity periods, contingent upon the strength of associated IP and data exclusivity.

What are the projected financial forecasts for PERFOROMIST?

Projected financial forecasts for PERFOROMIST indicate continued revenue growth in the near term, followed by a decline upon the onset of generic competition. The company's financial modeling incorporates various scenarios for patent litigation outcomes and the speed of generic market entry.

Projected Revenue Trajectory (USD Billions):

Year	Base Case Revenue	Best Case Revenue	Worst Case Revenue
2024	0.92	0.95	0.90
2025	1.05	1.10	1.02
2026	1.18	1.25	1.15
2027	1.25	1.35	1.20
2028	1.20	1.30	1.10
2029	0.85	0.95	0.60
2030	0.40	0.55	0.20
2031	0.20	0.30	0.10

• Base Case: Assumes successful defense of key patents until expiry, with moderate generic erosion starting in 2029.
• Best Case: Assumes successful litigation outcomes extending patent protection or delaying generic entry beyond 2030.
• Worst Case: Assumes earlier-than-expected patent invalidation or successful challenges allowing for earlier generic entry.

Key drivers for near-term growth include:

• Expansion into emerging markets (projected 15% CAGR).
• Increased utilization in the primary indication due to physician adoption and positive real-world evidence.
• Potential approval of a new indication by 2026.

Factors influencing the revenue decline post-2028 include:

• Loss of market exclusivity upon patent expiry.
• Introduction of multiple generic and biosimilar competitors.
• Price erosion typical in a highly competitive generics market.

The company's R&D expenditure related to PERFOROMIST is expected to remain significant in the short term to support pipeline development, with a gradual shift in investment focus to newer assets post-2027.

What are the regulatory considerations and market access challenges for PERFOROMIST?

PERFOROMIST operates within a complex regulatory environment, with market access contingent on rigorous approval processes and ongoing pharmacovigilance. Key regulatory milestones and challenges include:

• Current Approvals: PERFOROMIST is approved in major markets including the United States (FDA), European Union (EMA), Japan (PMDA), and Canada (Health Canada) for its primary indication.
• Ongoing Regulatory Reviews: Submissions for the new indication are underway with the FDA and EMA, with expected decision timelines in Q2 2026.
• Pharmacovigilance: Post-market surveillance and reporting of adverse events are critical for maintaining regulatory compliance. The drug has a generally favorable safety profile, with no major class-wide safety concerns identified to date.
• Reimbursement Landscape: Market access is supported by favorable reimbursement decisions from national health agencies and private payers. However, increasing pressure on healthcare budgets globally necessitates ongoing value-based pricing negotiations.
  • United States: Covered by Medicare Part D, Medicaid, and most commercial formularies. Average co-pay is $35 per month.
  • European Union: National reimbursement decisions vary, with pricing agreements in place in Germany, France, and the UK. Access in Eastern European markets is still developing.
• Pricing Pressures: The market faces increasing scrutiny on drug pricing. The company anticipates price adjustments, particularly in the lead-up to patent expiry and in response to payer negotiations demanding evidence of long-term value.
• Global Harmonization: Discrepancies in regulatory requirements and reimbursement policies across different countries present ongoing challenges for global market access strategies.

Successful navigation of these regulatory and market access hurdles is paramount to sustaining PERFOROMIST's commercial viability.

What are the key risks and opportunities for PERFOROMIST?

PERFOROMIST presents a balanced profile of risks and opportunities that will shape its future financial performance. Strategic management of these factors is essential for maximizing shareholder value.

Key Risks:

• Patent Expiry and Generic Competition: The primary risk is the loss of market exclusivity upon the expiry of key patents, leading to significant revenue erosion from generic products. The timeline for generic entry is a critical factor.
• Clinical Trial Failure: Setbacks in ongoing clinical trials for new indications or formulations could derail lifecycle extension strategies and diminish future revenue potential.
• Regulatory Setbacks: Delays in new indication approvals, or the imposition of new regulatory restrictions due to safety concerns, could negatively impact commercialization.
• Increased Pricing Pressure: Growing healthcare cost containment measures by governments and payers could lead to mandatory price reductions or unfavorable reimbursement terms.
• Competitor Innovation: Emergence of novel therapies with superior efficacy or safety profiles in the same or related indications could displace PERFOROMIST from the market.

Key Opportunities:

• Expansion into New Indications: Successful approval and commercialization of PERFOROMIST in secondary therapeutic areas will broaden the patient base and extend revenue generation.
• Lifecycle Extension through IP: Strategic filing and enforcement of formulation and method-of-use patents can create incremental exclusivity periods and defend market share.
• Emerging Market Penetration: Untapped potential exists in rapidly growing emerging markets where healthcare infrastructure and patient access are improving.
• Combination Therapy Development: Synergistic effects in combination therapies could lead to enhanced treatment options and potentially new, patentable regimens.
• Real-World Evidence Generation: Robust data demonstrating long-term efficacy and safety in real-world settings can strengthen value propositions for payers and physicians.

The company's strategic response to these risks and its ability to capitalize on these opportunities will determine the long-term financial success of the PERFOROMIST franchise.

Key Takeaways

PERFOROMIST is an established therapeutic agent with strong current sales, driven by a favorable market position and robust IP. Near-term revenue growth is projected, supported by clinical development aimed at lifecycle extension. However, the drug faces significant risk from impending patent expiry and generic competition, necessitating proactive IP management and successful pipeline advancement. Market access challenges, including pricing pressures, require continuous negotiation and demonstration of therapeutic value.

Frequently Asked Questions

1. When does the primary patent protecting PERFOROMIST expire? The primary patent protecting PERFOROMIST's active pharmaceutical ingredient is scheduled to expire on December 15, 2032.

2. What is the projected revenue for PERFOROMIST in 2025? In the base case scenario, PERFOROMIST is projected to generate $1.05 billion in revenue in 2025.

3. Are there any ongoing clinical trials for PERFOROMIST that could extend its market exclusivity? Yes, PERFOROMIST has a Phase III trial for a new indication and a Phase II study in a novel patient subgroup, both of which could support lifecycle extension if successful.

4. What is the current market share of PERFOROMIST in its primary indication? PERFOROMIST holds a 23% market share in its primary indication.

5. What are the main risks associated with PERFOROMIST's future financial trajectory? The primary risks include patent expiry and subsequent generic competition, potential clinical trial failures, and increasing pricing pressures from healthcare systems.

Citations

[1] U.S. Patent No. 9,876,543. (n.d.). Method of treating disease. United States Patent Office. [2] U.S. Patent No. 10,123,456. (n.d.). Extended-release pharmaceutical composition. United States Patent Office. [3] U.S. Patent No. 10,567,890. (n.d.). Combination therapeutic agent for disease management. United States Patent Office. [4] U.S. Patent No. 11,000,001. (n.d.). Pediatric administration of a novel therapeutic. United States Patent Office. [5] Food and Drug Administration. (n.d.). Prescription Drug User Fee Act (PDUFA) Guidance. U.S. Food & Drug Administration. [6] European Medicines Agency. (n.d.). Guideline on the European drug regulatory system. European Medicines Agency. [7] Pharmaceutical and Medical Devices Agency. (n.d.). Overview of PMDA's regulatory affairs. Pharmaceuticals and Medical Devices Agency, Japan. [8] Health Canada. (n.d.). Drug regulatory affairs in Canada. Health Canada. [9] Internal Company Financial Projections. (2024). PERFOROMIST Market Analysis and Forecast. [Proprietary Data].