FORMOTEROL FUMARATE; GLYCOPYRROLATE - Generic Drug Details

What are the generic drug sources for formoterol fumarate; glycopyrrolate and what is the scope of freedom to operate?

Formoterol fumarate; glycopyrrolate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Formoterol fumarate; glycopyrrolate has one hundred and ninety-two patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for FORMOTEROL FUMARATE; GLYCOPYRROLATE

International Patents:	192
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	5
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FORMOTEROL FUMARATE; GLYCOPYRROLATE
DailyMed Link:	FORMOTEROL FUMARATE; GLYCOPYRROLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for FORMOTEROL FUMARATE; GLYCOPYRROLATE

Constraining patent/regulatory exclusivity:

8,324,266

Dosage:

AEROSOL, METERED;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for FORMOTEROL FUMARATE; GLYCOPYRROLATE

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

Sponsor	Phase
University of Alabama at Birmingham	PHASE2
Chiesi Farmaceutici S.p.A.	Phase 3
Pearl Therapeutics, Inc.	Phase 3

See all FORMOTEROL FUMARATE; GLYCOPYRROLATE clinical trials

Pharmacology for FORMOTEROL FUMARATE; GLYCOPYRROLATE

Drug Class	Anticholinergic Cholinergic Muscarinic Antagonist beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Cholinergic Antagonists Cholinergic Muscarinic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for FORMOTEROL FUMARATE; GLYCOPYRROLATE

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for FORMOTEROL FUMARATE; GLYCOPYRROLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	8,815,258
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	10,716,753		Y
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	8,808,713		Y
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	9,415,009
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	8,703,806
Astrazeneca	BEVESPI AEROSPHERE	formoterol fumarate; glycopyrrolate	AEROSOL, METERED;INHALATION	208294-001	Apr 25, 2016		RX	Yes	Yes	8,324,266

International Patents for FORMOTEROL FUMARATE; GLYCOPYRROLATE

Country	Patent Number	Title	Estimated Expiration
Argentina	076621	COMPOSICIONES PARA EL SUMINISTRO DE ANTAGONISTAS MUSCARINICOS DE ACCION PROLONGADA Y AGONISTA DEL RECEPTOR ADRENERGICO B2 DE ACCION PROLONGADA. METODO DE TRATAMIENTO. SISTEMAS ASOCIADOS. INHALADOR DOSIFICADOR
Argentina	076806	COMPOSICIONES PARA EL SUMINISTRO DE AGENTES ACTIVOS MEDIANTE LAS VIAS RES-PIRATORIAS, Y METODOS Y SISTEMAS ASOCIADOS, COSUSPENSION, INHALADOR DOSIFI-CADOR
Argentina	076807	COMPOSICIONES METODOS Y SISTEMAS PARA EL SUMINISTRO DE DOS O MAS AGENTES ACTIVOS MEDIANTE LAS VIAS RESPIRATORIAS. METODO DE PREPARACION COMPOSICION
Argentina	121758	COMPOSICIÓN FARMACÉUTICA QUE PUEDE SUMINISTRARSE DESDE UN INHALADOR DOSIFICADOR
Argentina	122477	COMPOSICIONES PARA EL SUMINISTRO DE AGENTES ACTIVOS MEDIANTE LAS VÍAS RESPIRATORIAS, Y MÉTODOS Y SISTEMAS ASOCIADOS
Argentina	122478	COMPOSICIONES PARA EL SUMINISTRO PULMONAR DE ANTAGONISTAS MUSCARÍNICOS DE ACCIÓN PROLONGADA Y AGONISTAS DEL RECEPTOR ADRENÉRGICO b₂ DE ACCIÓN PROLONGADA, Y MÉTODOS Y SISTEMAS ASOCIADOS

Supplementary Protection Certificates for FORMOTEROL FUMARATE; GLYCOPYRROLATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435024	122021000026	Germany		PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; REGISTRATION NO/DATE: EU/1/20/1498 20201209
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
2435025	2019026	Norway		PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104
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
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
2435025	36/2019	Austria		PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220

Last updated: June 12, 2026

Formoterol Fumarate + Glycopyrrolate Market Dynamics and Financial Trajectory: Revenue Drivers, Patent/Exclusivity Overhang, and Competitive Risks

Formoterol fumarate plus glycopyrrolate is an established dual bronchodilator combination used in COPD, and its financial trajectory is shaped by (1) COPD population aging and treatment intensity, (2) payor preference and formulary placement versus LABA/LAMA competitors, (3) manufacturing cost and inhaler economics, and (4) the timing of patent and regulatory exclusivities that determine generic or biosimilar-like risk (generics in this case). In practice, this product’s growth is constrained less by demand and more by substitution dynamics within the LABA/LAMA class and by how defensible its inhaler and formulation patent estate remains relative to competing fixed-dose combinations.

How is the formoterol fumarate plus glycopyrrolate market structured and who buys it?

Direct market buyer profile

• COPD care is dominated by respiratory specialists and primary care. Real-world substitution pressure typically comes from primary care plus large integrated delivery networks and pharmacy benefit managers.
• Inhaled maintenance therapy is highly formulary-driven. A LABA/LAMA combination product’s growth depends on contracted placement and step therapy rules.

Key market structure features

• LABA/LAMA combinations sit in the middle of the COPD escalation ladder, often positioned after single bronchodilator therapy.
• Patients commonly “tubes through” multiple inhalers over time. That increases churn and makes adherence device performance and co-pay decisive.

Competitive set (class-based)

• The combination competes against other fixed-dose LABA/LAMA inhalers, including (by active ingredient class) dual bronchodilators from the same and competing manufacturers.
• Competitive differentiation is usually:
  • inhaler type and dosing regimen
  • perceived ease of use (device ergonomics)
  • patient switching costs for pharmacies and clinicians
  • payor rebates and restricted formulary access

What inhaler factors influence sales more than drug chemistry?

• Device is typically the largest measurable driver of adherence and persistence within COPD portfolios.
• Switch rates are influenced by:
  • breath-actuation vs metered-dose learning curve
  • inspiratory flow requirements
  • dose counters and perceived reliability
  • local contracting and pharmacy switching programs

What drives revenue performance for COPD dual bronchodilators like formoterol fumarate plus glycopyrrolate?

Core revenue drivers

• Patient prevalence and persistence: COPD prevalence continues to grow with age cohorts; persistence declines when payors restrict access or when patients experience tolerability issues.
• Formulary wins: Access through preferred tiers is strongly correlated with volume.
• Dose regimen and inhaler fit: Lower friction between device technique and successful inhalation improves long-term refills.
• Seasonality and exacerbations: While exacerbation reduction is clinically relevant, reimbursement and sales in many markets track maintenance utilization and inhaler refills rather than outcomes alone.

Typical financial trajectory in LABA/LAMA COPD

• Early-to-mid lifecycle products see revenue growth from uptake and formulary placement.
• Mid lifecycle growth slows as competitors expand coverage and generics enter adjacent combinations, forcing price pressure and rebate escalation.
• Later lifecycle performance becomes highly dependent on:
  • sustained formulary position
  • protection of inhaler-specific IP (device/formulation)
  • promotional spend and channel strategy
  • payer channel contracting

When do exclusivity protections expire for formoterol fumarate plus glycopyrrolate, and how do they affect generic entry risk?

How to think about exclusivity timing (for this specific combination) For a fixed-dose combination inhalation product, generic entry is usually blocked by one or more of the following:

1. Application-specific exclusivity (NCE/NDA exclusivities where applicable, and other FDA exclusivities tied to approval history).
2. Patent estate that covers:
   • formulation and delivery system characteristics
   • composition of matter (if present)
   • method-of-use (less common for classic maintenance indications, but can exist)
   • specific inhaler device or dosing characteristics

Generic entry mechanics

• Generic risk typically becomes material when relevant patents expire (or are successfully avoided via Paragraph IV litigation settlements or final invalidation).
• Even when the active pharmaceutical ingredients are old, combination products can remain protected through formulation/device patents.

What does this mean for valuation and near-term revenue risk?

• If the product’s remaining exclusivity window is short, revenue often shifts into “defense mode”:
  • increased rebates to defend tier placement
  • heavy contracting with payers
  • switching to longer-dated presentations or alternative SKUs where IP is stronger
• If relevant patents are still active and robust, revenue risk remains lower but still depends on competitive substitution within the LABA/LAMA class.

What patents protect formoterol fumarate plus glycopyrrolate, and how strong is the patent estate?

How patent strength is evaluated for this combination Patent strength for inhaled LABA/LAMA fixed-dose products generally breaks into:

• Composition and formulation patents: protect particle engineering, salt form, stability, spray/dose uniformity, and inhaler content.
• Method-of-use patents: can protect specific dosing regimens or patient subpopulations if claimed.
• Inhaler/device patents: protect mechanical or aerodynamic performance parameters and are a frequent source of “evergreening.”
• Manufacturing process patents: protect mixing, filling, and quality control.

Estate strength signals

• Many active fixed-dose combination programs show estates dominated by:
  • formulation/delivery patents rather than core API composition
  • multiple follow-on filings
• The highest risk is when:
  • formulation/device patents are weakly defensible or expire early
  • competitor generics have clear non-infringing design paths

Which geographic markets face the fastest substitution?

• Generic entry speed is typically fastest where:
  • payer pressure is highest
  • pharmacy distribution favors lowest net price
  • regulatory pathways are streamlined
• Revenue durability is higher in markets that maintain stronger brand access or where devices with specific IP are harder to replicate.

What patent litigation or Paragraph IV challenges affect formoterol fumarate plus glycopyrrolate?

Litigation drivers for fixed-dose combinations

• Paragraph IV challenges are typically filed against one or more listed patents in the Orange Book for the reference product.
• For inhaled products, defendants often focus on:
  • non-infringement through different formulation or particle properties
  • invalidity due to anticipation/obviousness
  • expiration timing if only late-expiring patents remain

Settlement dynamics that change financial trajectories

• Settlements often:
  • delay generic launch by a time-limited window
  • include distribution or supply arrangements
  • cap injunction scope to specific strengths or presentations

How do settlements typically show up in sales?

• If a settlement pushes generic launch beyond the near-term contract cycle, the brand usually maintains pricing and net-to-gross levels longer.
• If a settlement is short or narrow, expect:
  • accelerating discounting
  • increased patient switching risk
  • heightened competitor promotional activity in the final protected period

What is the FDA regulatory status and Orange Book listing status of formoterol fumarate plus glycopyrrolate?

Orange Book linkage

• The controlling question for financial risk is which patents are listed for the reference listed drug (RLD) and what claims they cover:
  • active ingredients and their specific forms
  • dosage form and strength
  • expiration dates

Featured-snippet answer

• For generic entry risk assessment, the financial impact is determined by the latest-to-expire listed patent that is relevant to generic copying and by any granted regulatory exclusivity tied to the NDA.

What FDA pathway choices influence competition?

• For inhaled combinations, generic applicants generally pursue ANDA pathways.
• The presence of multiple listed patents increases the chance of multi-patent challenges and multiple litigations.

How does formoterol fumarate plus glycopyrrolate compare with other LABA/LAMA COPD inhalers on market momentum and competitive positioning?

What to compare

• Net price trajectory and formulary position are more predictive than wholesale channel growth.
• Clinically, COPD care increasingly shifts across treatment lines:
  • LABA/LAMA dual therapy is often baseline maintenance
  • triple therapy (LABA/LAMA/ICS) can capture patients who escalate due to exacerbations

Competitive substitution pattern

• If a competitor product is preferred and has better device acceptance in real-world settings, it can capture share even if the pharmacology is similar.
• Brands with stronger device performance and better payer contracts generally sustain persistence better.

Where does substitution typically happen first?

• First switching typically occurs at the payer level:
  • formulary changes
  • step therapy requirements
  • prior authorization tightened for non-preferred brands
• Second switching occurs at patient behavior level:
  • technique problems
  • perceived symptom relief differences
  • refill compliance

What revenue exposure does formoterol fumarate plus glycopyrrolate have under generic launch scenarios?

Generic launch scenarios Three scenarios drive the forecast range:

1. Full launch at first allowable date: steep volume loss, net price compression, and rapid erosion of prescription share.
2. Delayed launch due to litigation or settlement: brand defends longer; generic uptake begins later and net price falls later.
3. Partial launch constrained by patents or product presentations: brand may lose some strengths or configurations first but retain others.

Financial impact channels

• Volume declines due to patient and prescriber switching.
• Net price declines due to rebate strategy changes and increased payer preference for generics.
• Reduced marketing efficiency because remaining patient base becomes more resistant or already stable.

How should businesses model net sales after generic entry?

• Use ramp assumptions for generic adoption and persistence tied to:
  • device similarity
  • co-pay differences
  • formulary tier placement
  • physician switching inertia

What manufacturing and IP barriers could delay or weaken generic competition for this combination?

Manufacturing barriers

• Inhaled product manufacturing is sensitive to:
  • stability requirements
  • dose uniformity
  • particle/aerodynamic performance or formulation characteristics
• Even if an ANDA is approved, launch can be delayed due to scale-up, validation failures, or supply chain constraints.

IP barriers

• Inhaler-specific formulation and delivery performance patents can limit “simple” generic copying.
• If multiple patents remain in force, generic applicants may redesign rather than litigate all claims.

Key Takeaways

• The financial trajectory for formoterol fumarate plus glycopyrrolate in COPD is primarily driven by formulary access, device-driven persistence, and substitution pressure from competing LABA/LAMA inhalers.
• Generic entry risk is determined not by the age of the APIs alone, but by the latest-to-expire listed formulation/device/method-of-use patents tied to the specific marketed combination product.
• Revenue durability is highest when the remaining patent estate blocks ANDA copying for key presentations and when the product remains preferred on payer formularies.
• The post-exclusivity period typically shifts from brand pricing to defense rebates, then to share defense or rapid volume erosion depending on whether litigation delays generic launch.

FAQs

1. How do inhaler device differences affect generic substitution rates for LABA/LAMA combinations?
2. What factors determine whether payers impose step therapy or prior authorization for dual bronchodilator COPD inhalers?
3. How do settlement timelines in Paragraph IV cases translate into brand net sales retention?
4. Which patent categories most often block generic inhalers: formulation, device, or method-of-use?
5. What is the typical share shift from LABA/LAMA to LABA/LAMA/ICS in COPD, and how does that impact sales of dual bronchodilators?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. ANDA approval pathways and regulatory exclusivity framework. U.S. Food and Drug Administration.