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. 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

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
Australia	2002244211
Canada	2438544	COMPOSITIONS BRONCHODILATATRICES ET METHODES ASSOCIEES (AEROSOL COMPOSITIONS CONTAINING FORMOTEROL FOR DELIVERY TO THE LUNGS VIA NEBULIZATION)
European Patent Office	1381346	COMPOSITIONS PHARMACEUTICALES COMPRENANT FORMOTEROL (PHARMACEUTICAL COMPOSITIONS CONTAINING FORMOTEROL)
Spain	2554476

Supplementary Protection Certificates for PERFOROMIST

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	SPC/GB21/029	United Kingdom		PRODUCT NAME: A COMBINATION OF FORMOTEROL, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, GLYCOPYRROLATE, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS AND SOLVATES THEREOF, AND BUDESONIDE INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS, ES; REGISTERED: UK EU/1/20/1498 (NI) 20201210; UK PLGB 17901/0352-001 20201210
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
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
2435024	PA2021511	Lithuania		PRODUCT NAME: FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS), GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENANTIOMERUS) IR BUDEZONIDO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, SOLVATUS ARBA ENATIOMERUS) DERINYS; REGISTRATION NO/DATE: EU/1/20/1498 20201209

Last updated: April 23, 2026

PERFOROMIST: Investment Scenario and Fundamentals Analysis

PERFOROMIST is an established brand name tied to a single, well-defined active ingredient and dosing profile in most markets where the term is used. The investment case therefore hinges on (1) patent and exclusivity position, (2) competitive intensity from authorized generics and inhaled-therapy peers, (3) payer and channel behavior for chronic respiratory use, and (4) near-term product life-cycle and manufacturing supply stability.

What is PERFOROMIST in commercial and regulatory terms?

PERFOROMIST is marketed as an inhaled respiratory medicine (most commonly linked in practice to formoterol-based long-acting bronchodilation in chronic obstructive pulmonary disease and related airway indications). Investment-grade diligence should treat the brand as a formulation and commercial wrapper around a specific inhaled drug substance and delivery device, where value is driven by:

• device usability and adherence outcomes,
• labeling scope and maintenance dosing,
• formulary placement and contracting terms.

Core implication for investors: if PERFOROMIST is effectively a “label + device + contracting” asset rather than a new chemical entity, the expected value curve is strongly correlated to exclusivity expiry, generic entry timing, and switch rates.

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How does the patent and exclusivity stack translate into expected revenue durability?

What exclusivity typically governs an inhaled respiratory brand?

For inhaled respiratory products, durability is usually a function of:

• composition-of-matter patents on the drug substance (often the largest lifetime driver),
• formulation and crystalline/polymorph patents,
• device and delivery system patents,
• regulatory exclusivities tied to originator approval pathways (where applicable),
• patent term extensions and pediatric exclusivity.

Investment scenario based on the practical commercialization reality

Because PERFOROMIST is a brand in a crowded therapeutic class, the baseline investor view should be:

• if primary substance patents have lapsed, the brand’s lifespan is mostly “contract duration” until generic penetration saturates,
• if device/formulation patents still stand, durability can extend through brand differentiation and legal-driven supply constraints.

Decision logic for fundamentals

• High durability scenario: remaining enforceable patents on formulation/device plus strong payer contracts limit substitution.
• Low durability scenario: expired substance patents with active generic competition compress net pricing and volume share quickly.
• Mid case: partial protection through device-specific claims and narrow switching windows.

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What fundamentals matter most for PERFOROMIST’s operating performance?

Demand drivers (what moves unit sales)

Key demand variables for chronic inhaled therapies:

• patient adherence (device friction drives missed doses),
• prescribing habit and guideline alignment,
• stability and availability (stock-outs shift patients and prescribers toward competitors).

For PERFOROMIST, the investment-relevant point is that inhaled chronic therapies tend to show sticky use when:

• the patient finds the device easy,
• prescribers maintain continuity,
• payers avoid frequent formulary churn.

Pricing and margin structure (where revenue is won or lost)

Inhaled brands typically face:

• average net price erosion on formulary pressure,
• higher rebates under managed entry agreements,
• share transfer to lower-cost competitors when contracting updates.

Net result investors model

• post-generic entry: sharp net price decline, then stabilization at a lower tier,
• mid-term: margin compression unless the brand maintains preference via contract terms or evidence-linked outcomes.

Channel mix (who pays and how they switch)

Payer-driven switching in inhaled therapy is common because:

• pharmacy benefit management and step-therapy rules decide access,
• patient co-pays determine “last-mile” switching.

Implication: PERFOROMIST’s fundamentals should be modeled on net revenue and access metrics, not list price.

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Who are the competitive substitutes and how does competition change the thesis?

Competitive pressure profile for inhaled long-acting bronchodilators

PERFOROMIST sits in a therapeutic field where competition comes from:

• same-class inhaled bronchodilators (often with varying dosing frequency and device types),
• combination products (dual or triple therapy improves outcomes but can shift patient mix),
• authorized generics and non-branded equivalents once exclusivity ends.

Investment scenario by competitive intensity

• Low intensity: competition focuses on therapeutic alternatives with limited formulary displacement; PERFOROMIST holds preference.
• High intensity: rapid substitution after generic availability; combination products pull new starts and switchers.

What this means for an investor

• If PERFOROMIST is near exclusivity expiry, the upside is dominated by execution on access and differentiation.
• If it has remaining enforceable IP, the downside risk is lower because competition is delayed or constrained.

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What is the near-term risk map for PERFOROMIST?

1) Exclusivity and litigation timing risk

For established inhaled brands, the most material downside is:

• generic launch timing relative to remaining patent estate,
• adverse legal outcomes accelerating market entry,
• injunction failure or narrow claim interpretations reducing enforceability.

2) Contracting risk

• payer reformularization can trigger volume loss,
• step-therapy policies can reduce new starts,
• pharmacy contracting changes can shift channel mix away from brand.

3) Supply and device performance risk

• manufacturing disruptions affect persistence and switching,
• device reliability issues can cause discontinuation even if pharmacology is unchanged.

4) Portfolio and life-cycle risk

• competing inhaled combinations can reduce incident use for monotherapy,
• prescriber and patient preference shift toward simplified regimens.

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What would a base-case financial thesis look like for an inhaled brand like PERFOROMIST?

A practical fundamentals model for a mature inhaled therapy should separate:

• volume (prescriber demand, adherence, persistence),
• net pricing (rebates, contracting, generic reference pricing),
• cost of goods and margins (device manufacturing complexity, supply chain),
• commercial spend efficiency (marketing intensity vs access outcomes).

Revenue drivers investors should track

• script volume trend (new starts vs renewals),
• persistence curves at 3, 6, 12 months,
• net price vs list price gap,
• formulary tier movement (preferred to non-preferred),
• generic market share capture if applicable.

What would constitute “good fundamentals” from an investment lens?

• stable or improving persistence,
• limited net price erosion relative to peers,
• continued preferred formulary positioning,
• controlled share loss to generics through contracts.

What would constitute “weak fundamentals”?

• accelerating patient switching after a competitor or generic milestone,
• sustained net price compression without volume stabilization,
• formulary downgrade or step-therapy tightening without mitigation.

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How should investors position PERFOROMIST within a portfolio strategy?

If PERFOROMIST has remaining enforceable exclusivity

A conservative bullish posture targets:

• upside from delayed substitution,
• incremental margins if contracting holds,
• limited legal-driven entry timing risk.

If exclusivity is largely exhausted or nearing expiry

A conservative posture targets:

• downside containment via contract retention,
• valuation anchored to expected net price decline and volume attrition,
• optionality from device/formulation differentiation and channel execution.

If the brand is already fully exposed to generics

The investment case becomes:

• cash-flow durability,
• manufacturing and operating leverage,
• competitive positioning in pharmacy channels.

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Key Takeaways

• PERFOROMIST’s investment durability is driven less by chemistry novelty and more by access mechanics: exclusivity status, payer contracts, device adherence, and substitution speed.
• The core downside risks cluster around exclusivity or litigation outcomes, formulary step-therapy changes, and generic launch timing.
• The core upside case rests on holding preferred status, maintaining persistence, and slowing net price erosion through contractual differentiation.

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FAQs

1) Is PERFOROMIST mainly a patent-driven or contract-driven asset?

It is primarily a contract-driven asset once substantive exclusivity weakens, with patent status determining how long contract leverage can be sustained.

2) What performance metric best predicts future revenue for inhaled chronic brands?

Persistence and adherence are the most predictive because they stabilize renewal volume and reduce churn from switching.

3) Does generic entry typically cause only price declines or also volume loss?

Both. Generic entry generally reduces net price and accelerates switching, especially when payers update tiers or enforce step-therapy.

4) How does device design affect investment outcomes for inhaled brands?

Device usability influences adherence and persistence; that directly impacts renewals and reduces the effectiveness of competing substitution strategies.

5) What is the dominant competitive threat to mature inhaled monotherapies?

Combination products and authorized generics, because they capture both new starts and switchers through improved regimen convenience and payer preference.

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References

[1] Bloomberg Information Services (market data and company/therapeutic-area coverage).
[2] FDA Drug Labels and Approved Drug Products databases.
[3] EMA product information and EPAR documentation for inhaled respiratory therapies.