Last Updated: June 9, 2026

PERFOROMIST Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 22nd, 2021.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for PERFOROMIST?
  • What are the global sales for PERFOROMIST?
  • What is Average Wholesale Price for PERFOROMIST?
Summary for PERFOROMIST
Recent Clinical Trials for PERFOROMIST

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

SponsorPhase
Mylan Inc.Phase 3
Theravance BiopharmaPhase 3
Chiesi Farmaceutici S.p.A.Phase 2

See all PERFOROMIST clinical trials

Pharmacology for PERFOROMIST
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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 ⤷  Start Trial ⤷  Start Trial
Viatris Specialty PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Start Trial ⤷  Start Trial
Viatris Specialty PERFOROMIST formoterol fumarate SOLUTION;INHALATION 022007-001 May 11, 2007 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for PERFOROMIST

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

Country Patent Number Title Estimated Expiration
Japan 2015178506 霧状化を経て肺に送達するためのフォルモテロール含有エアゾール組成物 (AEROSOL COMPOSITIONS CONTAINING FORMOTEROL FOR DELIVERY TO LUNGS VIA NEBULIZATION) ⤷  Start Trial
Spain 2554476 ⤷  Start Trial
Portugal 1381346 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PERFOROMIST

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 132019000000087 Italy ⤷  Start Trial PRODUCT NAME: UNA COMBINAZIONE DI GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI) E FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI)(BEVESPI AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1339, 20181220
2435025 2019C/532 Belgium ⤷  Start Trial PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435024 PA2021511,C2435024 Lithuania ⤷  Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Last updated: April 22, 2026

PERFOROMIST: Market Dynamics and Financial Trajectory

PERFOROMIST is a brand name used in market practice for formoterol fumarate (an inhaled long-acting beta2-agonist, LABA) in chronic obstructive pulmonary disease (COPD) and, in some territories, other obstructive airway indications where LABAs are used as controller therapy. The financial trajectory for this class of therapy is driven by (1) COPD prevalence and access to inhaled maintenance regimens, (2) competitive substitution across inhaler devices and formulations, (3) payer tilt toward combination therapy, and (4) patent and exclusivity dynamics around legacy LABA molecules and device/combination line extensions.


What are the demand-side market dynamics for PERFOROMIST (formoterol) in COPD?

1) COPD maintenance therapy shifts toward combinations

Formoterol products compete in the COPD maintenance setting where payers and clinicians prefer inhaled maintenance therapy that delivers bronchodilation with higher clinical consistency. In the broader COPD market, maintenance regimens increasingly concentrate around:

  • LABA/LAMA combinations (greater bronchodilation coverage than LABA monotherapy)
  • Triple therapy (LABA/LAMA/ICS) where exacerbation risk supports inhaled corticosteroid inclusion

This shifts share away from LABA-only products over time, particularly in markets where guidelines and payer formularies incentivize combination regimens. The substitution pressure is not uniform across geographies, but it is structural.

2) Device preference and switch behavior

For inhaled products, market pull comes from usability and perceived effectiveness, with switch behavior influenced by:

  • Inhaler device class (pressurized metered-dose inhaler vs dry powder vs nebulized)
  • Dose convenience and dosing frequency
  • Patient training and adherence performance, which can impact real-world persistence and outcomes

Where PERFOROMIST is positioned around specific device usability (typical in inhaled brand competition), it faces competition from newer device generations that reduce steps and improve dose reliability.

3) Payer dynamics: step therapy and formulary placement

Formoterol monotherapies often face:

  • Step edits requiring prior trial of cheaper options or combination therapy
  • Formulary tiering that places combination inhalers above monotherapy, or uses restricted access for monotherapy in higher-risk cohorts
  • Rebates and contracting that compress net pricing for brands in crowded inhaled categories

Net revenue growth tends to track broader COPD inhaler contracting patterns more than headline list price.


How does competition shape PERFOROMIST’s share and pricing?

1) Direct competition: other LABAs and combination inhalers

Formoterol competes against:

  • Other LABAs (molecules vary by market)
  • Combination inhalers where formoterol is part of LABA/LAMA or LABA/ICS products
  • Fixed-dose regimen substitutions driven by guideline updates

Competitive effect shows up as:

  • Higher promotional spend to defend share
  • Discounting and rebate intensity to maintain formulary position
  • Channel pressure from pharmacy benefit structures and large payer networks

2) Indirect competition: genericization and line-extension pressure

Over time, inhaled respiratory categories see:

  • Generic or biosimilar-like erosion in comparable therapy areas where legal and regulatory conditions permit
  • Line extensions via new devices, combination products, or reformulations that capture higher share

If PERFOROMIST’s core molecule faces generic alternatives in a given territory, its financial trajectory typically follows a pattern: share stability initially, then gradual net pricing decline unless reinforced by device advantage or contracted exclusivity.

3) Pricing power is constrained by the inhaled category’s consolidation

The inhaled COPD market has high switching and multiple manufacturers. Pricing power is constrained because:

  • Payers compare across therapeutic equivalence, not just molecule
  • Pharmacy procurement uses volume leverage for dominant inhaler portfolios
  • Clinical differentiation is often smaller than what device and adherence claims allow

What drives the unit and revenue trajectory over time?

1) Two-phase sales path typical for established inhaled brands

For established COPD inhalers, sales often follow:

  1. Defend-and-grow phase (formulary access + patient base retention + limited substitution)
  2. Deflation and share drift phase (combination preference + competitive entry + pricing pressure)

PERFOROMIST’s financial trajectory is best modeled as a maturity-phase inhaled respiratory product with upside only if it maintains differentiated device access or holds a formulary position that prevents substitution.

2) Revenue is increasingly net-price dependent

For inhaled brands, gross-to-net dilution comes from:

  • Contract rebates
  • Performance-related arrangements
  • Competitive buy-downs

Net revenue growth, when it occurs, usually comes from:

  • Share gains in specific payer segments
  • Persistency improvement through device performance and patient education support

What is the most likely financial trajectory for PERFOROMIST (portfolio-level view)?

Trajectory drivers

The following are the key financial levers for a formoterol-based inhaled brand:

  • Market access survival: whether PERFOROMIST remains on key formularies without restrictive step edits
  • Substitution protection: whether it competes effectively against combination inhalers
  • Net price resilience: whether rebate intensity stays manageable versus competing respiratory brands
  • Device differentiation: whether the product holds an adherence advantage that supports persistence

Expected financial shape

In mature respiratory markets, a typical financial path for a LABA-based brand is:

  • Plateauing volume as patients migrate to combination therapy
  • Falling net pricing as payer contracting tightens
  • Sales decline unless there is a portfolio offset (for example, combination products under the same corporate umbrella)

A brand in this position can still generate cash, but growth is usually modest and expense discipline is critical.


Business implications: where PERFOROMIST fits in portfolio decisions

1) R&D and lifecycle strategy

A mature inhaled brand typically supports two strategic moves:

  • Device lifecycle optimization (reduce failure rates, improve usability, support adherence)
  • Portfolio migration into combination regimens where payer demand is shifting

Formoterol’s value proposition is strongest when it becomes part of a regimen aligned with guideline-driven treatment escalation.

2) Commercial strategy

For market defense:

  • Target “steady-state” patient segments where monotherapy is still accepted
  • Use payer-specific contracting to reduce switch incentives
  • Invest in training to protect real-world persistence

For growth:

  • Align with combination expansion where clinicians already escalate therapy
  • Maintain formulary access during transitions, so patients do not fully churn to competitor regimens

Key Takeaways

  • PERFOROMIST (formoterol-based inhaled LABA) operates in a COPD maintenance market where demand structurally shifts toward LABA/LAMA and triple therapy, which pressures LABA monotherapy share.
  • Financial trajectory is typically characterized by volume plateau then net-price deflation, driven by payer contracting, rebate pressure, and substitution to combination inhalers.
  • The main variables that determine whether PERFOROMIST declines slowly or more sharply are formulary access stability, net pricing resilience, and device-driven adherence/persistence.
  • Portfolio outcomes depend on whether the commercial engine supports a migration path into combination regimens, not only brand defense.

FAQs

1) Is PERFOROMIST growth primarily volume-led or price-led?

It is typically net price-led under competitive pressure, because volume growth is constrained by substitution to combination inhalers.

2) What is the biggest sales headwind for formoterol brands in COPD?

The biggest headwind is payer and guideline preference for combination therapy (LABA/LAMA and triple therapy), which displaces LABA monotherapy over time.

3) Do inhaler devices change the competitive outcome for PERFOROMIST?

Yes. Device class and usability affect adherence and switching, which can influence persistence and formulary value.

4) What commercial lever most impacts net revenue for inhaled brands?

Contracting and rebate intensity drive gross-to-net outcomes more than list price.

5) What business move best stabilizes long-term earnings for a LABA brand?

A portfolio migration into combinations that match COPD escalation patterns is the most reliable stabilizer.


References

[1] Global Initiative for Chronic Obstructive Lung Disease (GOLD). GOLD Report: Global Strategy for Prevention, Diagnosis and Treatment of COPD. Latest edition. https://goldcopd.org/

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.