ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - Generic Drug Details

What are the generic sources for albuterol sulfate; ipratropium bromide and what is the scope of patent protection?

Albuterol sulfate; ipratropium bromide is the generic ingredient in four branded drugs marketed by Boehringer Ingelheim, Aiping Pharm Inc, Apotex Inc, Cipla, Luoxin Aurovitas, Nephron, Ritedose Corp, Sun Pharm, Teva Pharms, Watson Labs Teva, and Pharmobedient, and is included in twelve NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Albuterol sulfate; ipratropium bromide has seventy-two patent family members in thirty-five countries.

Fourteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

International Patents:	72
US Patents:	4
Tradenames:	4
Applicants:	11
NDAs:	12
Finished Product Suppliers / Packagers:	14
Clinical Trials:	4
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
DailyMed Link:	ALBUTEROL SULFATE; IPRATROPIUM BROMIDE at DailyMed

Recent Clinical Trials for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

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

Sponsor	Phase
James J. Peters Veterans Affairs Medical Center	Phase 2
University of Texas Southwestern Medical Center	Phase 4
Dey	Phase 3

See all ALBUTEROL SULFATE; IPRATROPIUM BROMIDE clinical trials

Generic filers with tentative approvals for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Applicant	Application No.	Strength	Dosage Form
		EQ 0.083% BASE;0.017%	SOLUTION;INHALATION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

A07DA	Antipropulsives
A07D	ANTIPROPULSIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

N02AA	Natural opium alkaloids
N02A	OPIOIDS
N02	ANALGESICS
N	Nervous system

R01AX	Other nasal preparations
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
COMBIVENT RESPIMAT	Inhalation Aerosol	albuterol sulfate; ipratropium bromide	100 mcg/20 mcg per actuation	021747	1	2023-03-30

US Patents and Regulatory Information for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	7,396,341		Y		Y
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	9,027,967		Y		Y
Luoxin Aurovitas	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	206532-001	Jul 8, 2020		DISCN	No	No
Boehringer Ingelheim	COMBIVENT	albuterol sulfate; ipratropium bromide	AEROSOL, METERED;INHALATION	020291-001	Oct 24, 1996		DISCN	No	No
Sun Pharm	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	207875-001	Aug 7, 2017	AN	RX	No	No
Apotex Inc	ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE	albuterol sulfate; ipratropium bromide	SOLUTION;INHALATION	077117-001	Dec 31, 2007		DISCN	No	No
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011		RX	Yes	Yes	7,837,235		Y		Y

Expired US Patents for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	5,911,851
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	5,405,084
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	7,802,568
Boehringer Ingelheim	COMBIVENT	albuterol sulfate; ipratropium bromide	AEROSOL, METERED;INHALATION	020291-001	Oct 24, 1996	5,603,918
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	6,149,054
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	6,453,795
Boehringer Ingelheim	COMBIVENT RESPIMAT	albuterol sulfate; ipratropium bromide	SPRAY, METERED;INHALATION	021747-001	Oct 7, 2011	6,503,362

International Patents for ALBUTEROL SULFATE; IPRATROPIUM BROMIDE

Country	Patent Number	Title	Estimated Expiration
Portugal	1706210
Colombia	5720979	DISPOSITIVO BLOQUEADOR PARA UN MECANISMO TENSOR DE BLOQUEO CON UNA TOMA DE FUERZA ACCIONADA POR RESORTE
Japan	2005537130
Japan	4411209
Serbia	50551	SREDSTVO ZA DRŽANJE FLUIDNE KOMPONENTE (DEVICE FOR HOLDING A FLUIDIC COMPONENT)
Japan	2009536051
European Patent Office	2015811

Albuterol Sulfate + Ipratropium Bromide: Market Dynamics and Financial Trajectory

Last updated: April 26, 2026

Summary: Albuterol sulfate and ipratropium bromide are off-patent, long-established respiratory therapies used in combination in acute-care and chronic symptom management settings. Market dynamics are shaped by (1) fixed generic pricing pressure, (2) channel mix between hospital/EMS and retail, (3) guideline-driven utilization of inhaled therapies, and (4) competitive substitution among nebulized and inhaler formats. Financial trajectory is best characterized as mature volume with periodic unit-price resets from generics, modest category growth tied to population and exacerbation rates, and episodic revenue volatility from supply, reimbursement, and competitive entry timing.

How big is the market and what drives demand for this drug combination?

Category: short-acting inhaled bronchodilators and anticholinergics for reversible airflow obstruction (COPD) and acute bronchospasm management (including emergency settings). The combination is used when patients need both beta-2 adrenergic agonism and muscarinic antagonism, most commonly via nebulization.

Core demand drivers

• COPD prevalence and exacerbation burden: higher exacerbation frequency increases utilization of rescue bronchodilation in clinics, ERs, and hospitals.
• Acute care protocols: combination bronchodilation is embedded in emergency treatment pathways for acute bronchospasm, where dosing is frequently delivered via nebulization in controlled settings.
• Population aging: higher COPD burden in older cohorts increases baseline prescriptions and acute visits.
• Clinic and hospital formularies: hospital purchasing locks in negotiated unit costs for generics, stabilizing volume while compressing margins.
• Transition between delivery devices: utilization shifts between nebulizers and metered-dose inhalers or inhaler equivalents can reallocate volume within respiratory symptom management.

What this means for financial trajectory: demand grows with patient numbers and acute episodes, but revenue growth depends on unit economics because generics set price floors and substitution is easy.

What is the competitive landscape and how does substitution affect revenue?

Competitive set (functional substitutes)

• Single-agent bronchodilators: albuterol-only or ipratropium-only regimens can substitute when combination therapy is not clinically required.
• Other bronchodilator combinations: other beta-2 agonist plus anticholinergic products (or equivalent inhalation regimens) compete for the same “rescue combination” use case.
• Delivery format substitution: nebulized therapy competes with inhaler-based regimens, especially outside hospitals.

Substitution mechanics

• Generic interchangeability: albuterol sulfate and ipratropium bromide are typically available as generics; buyers can switch manufacturers with minimal switching friction if quality systems and supply performance are acceptable.
• Procurement leverage: hospitals and health systems negotiate price and volume, which pressures manufacturer net pricing.
• Clinical protocol anchoring: while protocols can specify combination therapy, they often still allow pathway substitutions (device choice, agent choice, dosing frequency).

Financial impact

• Volume stability, margin compression: the combination tends to behave like a mature, protocol-driven commodity where sales persist but revenue per unit erodes with additional generic entrants and contracting cycles.
• Lumpy impacts from purchasing cycles: quarter-to-quarter revenue can swing with contract awards, inventory build, and product availability.

How does pricing typically evolve after patents expire?

Patent posture (market reality)

• Both active ingredients are widely marketed and commercially mature; the combination is not a typical protected franchise in most geographies, so pricing is dominated by generic competition and contracting.

Pricing pattern

• Initial post-entry phase: discounts deepen as additional manufacturers enter and formularies update.
• Consolidation phase: fewer net-active bidders remain after market shakeouts, leading to stabilization in unit pricing but not a return to branded-like margins.
• Contract-driven resets: hospital and distributor agreements periodically reset net price, often downward.

Net effect on revenue trajectory

• Managed growth on volume: revenue tracks utilization and patient encounters more than price.
• Limited upside from premium differentiation: because active ingredients are the same, differentiation is usually delivery device performance or supply reliability, which affects contract retention more than baseline pricing.

What channels dominate and how do they change financial outcomes?

Channel split

• Institutional (hospital, ED, EMS): high-frequency use in acute care. Revenue is influenced by group purchasing organization (GPO) dynamics, formulary placement, and supply continuity.
• Retail and specialty distribution: used for outpatient rescue and symptom control, typically at lower cadence than acute care but with broader geographic spread.

Channel-specific financial dynamics

• Institutional: pricing is negotiated; volume is governed by clinical pathways and contract terms. Revenue tends to be steadier but margin is thinner.
• Retail: pricing reflects generic shelf dynamics and reimbursement. Revenue can be more sensitive to competitive entry timing, payer preferences, and patient adherence.

What is the drug’s clinical utility and how does that translate to market persistence?

Clinical positioning

• Albuterol sulfate: short-acting beta-2 agonist for rapid bronchodilation.
• Ipratropium bromide: short-acting muscarinic antagonist that adds bronchodilation, especially in COPD exacerbations and in patients who need more than a beta-agonist alone.

Why it persists

• It aligns with acute and rescue needs where bronchodilation is expected quickly.
• It fits protocols that require combination bronchodilation for more severe symptoms.
• It remains accessible due to generic availability and multiple delivery options.

Market persistence implication

• Expect continued baseline demand, with competitive pressure driving profitability declines rather than demand collapse.

What do procurement and reimbursement dynamics imply for financial performance?

Procurement

• Tender cycles: hospital and distributor tenders set the near-term ordering pattern.
• Supply assurance: shortage events or manufacturing interruptions can temporarily lift net price or disrupt revenue volume, then normalize when supply returns.

Reimbursement

• Generic reimbursement floors: payers typically reimburse at levels that preserve generic access but limit premium pricing.
• Formulary controls: payer and health system formulary placement can support utilization, but switching remains straightforward when multiple generics are available.

Financial trajectory summary

• Stable-to-slow top-line growth: driven by patient encounters and COPD burden.
• Downward margin drift: driven by generic price compression and contracting leverage.

How has the category likely behaved over the last decade (high-level trajectory)?

Across mature respiratory bronchodilator categories, the typical long-run pattern is:

• Revenue: grows slowly with utilization increases (population and COPD/exacerbation burden) and is periodically jolted by procurement and supply events.
• Pricing: trends downward with generic competition and contract resets.
• Profitability: structurally constrained by commoditization, with cost control and supply reliability as key differentiators.

Applied to this combination:

• The combination remains protocol-relevant, so volume remains durable.
• Pricing is anchored to generic benchmarks and negotiated net pricing, limiting upside.

What product form factors matter financially for this combination?

Delivery method

• Nebulized formulations tend to concentrate sales in acute and institutional settings.
• Inhaler-based alternatives can reallocate use away from nebulization where device preference or payer incentives favor inhaler therapy.

Financial impact

• Any shift in device preference affects unit volumes and revenue mix across channels.
• Products that best meet procurement requirements (price, packaging, stability, and supply reliability) typically retain share even as active ingredients remain interchangeable.

What are the key risks to the financial trajectory?

1. Generic competition intensity: new entrants and aggressive contracting can reset net pricing downward.
2. Supply-chain interruptions: manufacturing or raw-material disruptions can cause lost sales, then partial rebounds.
3. Protocol changes: if guidelines emphasize different rescue strategies (for example, alternative bronchodilation delivery routes or combinations), the share of combination nebulized dosing can decline.
4. Device substitution trends: broader shift from nebulizers to inhalers in certain settings can compress nebulized volumes.
5. Payer steering: formulary and prior authorization rules can shift utilization within the class.

What are the key upside levers?

1. Institutional contract wins and renewal: winning and retaining hospital and distributor agreements.
2. Broad availability and consistent supply: reducing stockouts and enabling continuous ordering.
3. Reduced total cost of care in protocols: products that fit dosing and workflow needs can support formulary persistence.
4. Geographic expansion via wholesalers: increasing access where procurement is fragmented.

How to interpret the financial trajectory for investors and R&D planners?

For investors

• Treat the combination as a mature respiratory commodity with growth mainly from utilization and managed by contracting.
• Model revenue with volume-led assumptions and net price compression scenarios tied to generic entry and contract resets.
• Use supply and contract timing as primary drivers of quarter-to-quarter variability.

For R&D and commercialization

• In a commoditized active-ingredient landscape, differentiation must come from delivery system performance, manufacturing scale and reliability, or labeling/protocol fit that improves institutional uptake.

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Key Takeaways

• Albuterol sulfate plus ipratropium bromide is a protocol-driven, mature respiratory combination with durable demand tied to COPD burden and acute bronchospasm management.
• Generic substitution and procurement leverage dominate market dynamics, pushing net pricing down and compressing margins.
• Financial trajectory is typically volume-stable with price-led declines, with revenue volatility driven by contracting cycles and supply continuity.
• Growth is best assessed via channel utilization (institutional vs retail), not by premium pricing.

FAQs

1) Why does this combination keep selling despite generic availability?
Clinical protocols use it when patients need both beta-2 bronchodilation and anticholinergic bronchodilation. Its role in acute care and COPD symptom management preserves baseline utilization.

2) What variable most affects revenue: unit price or prescriptions volume?
Volume and channel utilization usually drive revenue more, while net price is structurally pressured by generic competition and negotiated contracting.

3) Which channel tends to control profitability for this product class?
Institutional purchasing controls net pricing through tenders and contracts, compressing margins relative to list-price dynamics; retail is also price-pressured but can be less contract-constrained.

4) What could cause short-term revenue swings?
Hospital contract timing, distributor ordering patterns, and any supply interruption that forces temporary stockouts.

5) Is the main path to growth clinical or commercial?
Commercial, through institutional contract renewal and consistent supply, supported by clinical protocol fit. Clinical differentiation is constrained because the actives are commoditized.

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References

[1] FDA. Drug Trials Snapshots: Albuterol Sulfate. U.S. Food and Drug Administration.
[2] FDA. Ipratropium Bromide. U.S. Food and Drug Administration (Drug Label Information).
[3] Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global Strategy for the Diagnosis, Management, and Prevention of COPD.
[4] National Health Service (NHS). Ipratropium and Albuterol Nebuliser Information (clinical use and administration context).