MAXAIR Drug Patent Profile

When do Maxair patents expire, and what generic alternatives are available?

Maxair is a drug marketed by Bausch and is included in two NDAs.

The generic ingredient in MAXAIR is pirbuterol acetate. There are three drug master file entries for this compound. Additional details are available on the pirbuterol acetate profile page.

Summary for MAXAIR

US Patents:	0
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	2,177
DailyMed Link:	MAXAIR at DailyMed

US Patents and Regulatory Information for MAXAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	019009-001	Dec 30, 1986		DISCN	No	No
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	020014-001	Nov 30, 1992		DISCN	No	No

Expired US Patents for MAXAIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	020014-001	Nov 30, 1992
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	019009-001	Dec 30, 1986
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	019009-001	Dec 30, 1986
Bausch	MAXAIR	pirbuterol acetate	AEROSOL, METERED;INHALATION	019009-001	Dec 30, 1986

International Patents for MAXAIR

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

Country	Patent Number	Title	Estimated Expiration
Yugoslavia	25272
Philippines	15467	METHOD FOR TREATING CONGESTIVE HEART FAILURE
Germany	2204195
Austria	315842

MAXAIR (albuterol) Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is MAXAIR’s market position?

MAXAIR is a U.S. brand for albuterol (a short-acting beta-2 agonist, SABA) delivered as MAXAIR® metered-dose products (common market forms include the MAXAIR AutoHaler and related albuterol pressurized inhaler formats). The product sits in a mature, highly substitutable respiratory category where patent-protected innovation is limited, and branded economics are driven by formulation/device differentiation, payer contracting, and substitution velocity to authorized generics.

Market structure

• Therapeutic class: SABA for acute relief of bronchospasm in asthma and COPD
• Competitive set: other SABA inhalers (multiple molecules and device formats), plus manufacturer-sponsored generics and pharmacy counter substitution
• Key economic driver: rapid movement toward authorized generics after brand exclusivity erosion

Implication for dynamics

• MAXAIR competes less on clinical differentiation and more on price, rebate execution, channel access (PBM contracts), and device usability perceptions.

What demand forces move MAXAIR volume?

MAXAIR demand behaves like other rescue-inhaler products: it tracks diagnosed asthma prevalence, switching between inhaler devices, and payer insistence on preferred SABA/generic coverage.

Primary demand forces

• Asthma and COPD prevalence: chronic airflow disease incidence and diagnosis rates influence baseline inhaler usage.
• Guideline practice patterns: overall prescriptions shift slowly with guideline cycles; rescue inhaler use remains persistent even as controller therapies expand.
• Substitution pressure: pharmacies and PBMs push lower net-cost options within the SABA bucket.
• Device and adherence: user experience and actuation reliability affect repeat fills for inhaler brands versus generics of differing devices.

How does payer and PBM contracting affect MAXAIR pricing power?

Branded MAXAIR pricing power is constrained by:

• Formulary preference tiers that typically favor generic albuterol or preferred SABA equivalents
• Rebate requirements to maintain formulary placement in commercial and Medicare Part D plans
• Wholesale acquisition cost vs net price gap driven by rebates and chargebacks

Market reality

• In mature inhaler categories, the brand’s ability to hold share depends on sustaining net price competitiveness. When authorized generics expand, branded volume typically declines unless the brand holds a differentiated device advantage that PBMs still cover.

How competitive threats show up in revenue trajectory

MAXAIR faces three recurring competitive threats:

1. Authorized generic entry and substitution
   • When generic/authorized generic versions are available, pharmacy substitution accelerates and branded share erodes.
2. Multiple brand-device rivals
   • Even within “albuterol,” device format differences can shift consumer and payer preferences temporarily.
3. Shift to preferred rescue options
   • PBMs can steer to whichever SABA is cheapest within their contract framework, independent of patient history.

What is the likely financial trajectory for MAXAIR?

MAXAIR’s financial trajectory in the U.S. marketplace is expected to show the same profile as most mature, largely substitutable inhaler brands:

• Peak or plateau period driven by exclusivity and active promotion
• Downward revenue slope once authorized generics and/or equivalent inhalers widen availability and PBMs tighten SABA preferencing
• Stabilization only when the brand holds a contract position and/or device-based differentiation that reduces switching

Category economics that govern MAXAIR

• Net revenue: structurally reduced by rebates/discounting once branded status loses advantage.
• COGS and channel: inhaler manufacturers face ongoing manufacturing scale economics; margin depends on volume mix and trade spending.
• Marketing efficiency: branded spend typically declines post-peak as share loss becomes inevitable.

What do known product and regulatory signals imply for MAXAIR’s market path?

Regulatory and substitution environment

Albuterol inhalers are a mature class with extensive generic penetration. MAXAIR’s trajectory is therefore dominated by:

• FDA approval status of competing products
• Timing of generic entry windows
• Therapeutic equivalence leading to substitution

Does MAXAIR have a “drug lifecycle” profile that investors can model?

Yes. For mature SABA brands, investors typically model:

• Share erosion curves after generic/authorized generic availability
• Net price compression driven by PBM rebate pressure
• Volume stabilization only when patient/device switching costs remain high

Where is value created: brand, device, or channel?

For MAXAIR specifically, value creation is most commonly:

• Channel access (preferred status on formularies)
• Net pricing execution (rebates/discounting)
• Device performance and patient retention (less switching within the patient base)

Notably, therapeutic differentiation does not typically justify sustained premium pricing once generics are accessible.

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Market dynamics checklist for MAXAIR (what to watch)

Variable	What moves it	Expected direction under generic competition
Prescriptions	PBM formulary preference and pharmacy substitution	Downward share for branded MAXAIR
Net price	Rebates and chargebacks; contract renegotiation	Net price declines
Volume	Patient retention for device format	Stabilizes only if switching barriers exist
Channel inventory	Wholesale buying pattern around contract changes	Periodic volatility around rebate/contract updates
Competitive intensity	Additional authorized generics and alternative devices	Increases over time

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Key Takeaways

• MAXAIR operates in a mature, highly substitutable SABA albuterol market where payer contracting and authorized generic substitution determine branded economics.
• The financial trajectory typically follows a post-exclusivity decline driven by net price compression and share erosion, with partial stabilization only if the brand maintains PBM access and device-driven patient retention.
• MAXAIR’s revenue model is less about clinical superiority and more about formulary positioning, rebate execution, and switching friction.

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FAQs

1) What drives MAXAIR revenue most in the current market phase?
Payer formulary access and net price execution (rebates/discounts) plus pharmacy substitution dynamics.

2) How does generic entry typically affect MAXAIR?
It usually compresses net price and accelerates branded share loss as pharmacies and PBMs shift to lower-cost equivalents.

3) What metrics best track MAXAIR’s trajectory?
Script share trends, pharmacy channel sell-through, and net price after rebates versus gross price.

4) Does MAXAIR compete only on albuterol molecule equivalence?
No. It competes on device format usability and contract placement within PBM preferred networks.

5) What is the most realistic lifecycle pattern for MAXAIR as a SABA brand?
Peak or plateau followed by a multi-year downward slope, with limited stabilization if device and contracting sustain a residual differentiated position.

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References

[1] FDA. “Albuterol Sulfate Inhalation Products.” FDA Drug Databases (accessed via public FDA product and labeling resources). APA.
[2] FDA. “Drug Approval Reports and Product Labeling for Inhalation Bronchodilators.” FDA (public resources). APA.
[3] National Library of Medicine. “Albuterol.” PubChem and/or Drug Information resources. APA.