PROAIR DIGIHALER Drug Patent Profile

When do Proair Digihaler patents expire, and when can generic versions of Proair Digihaler launch?

Proair Digihaler is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in PROAIR DIGIHALER is albuterol sulfate. There are thirty-eight drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the albuterol sulfate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Proair Digihaler

A generic version of PROAIR DIGIHALER was approved as albuterol sulfate by SUN PHARM INDUSTRIES on December 5^th, 1989.

Summary for PROAIR DIGIHALER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	1
Patent Applications:	6,134
Drug Prices:	Drug price information for PROAIR DIGIHALER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PROAIR DIGIHALER
What excipients (inactive ingredients) are in PROAIR DIGIHALER?	PROAIR DIGIHALER excipients list
DailyMed Link:	PROAIR DIGIHALER at DailyMed

See drug prices for PROAIR DIGIHALER

Recent Clinical Trials for PROAIR DIGIHALER

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

Sponsor	Phase
Wake Forest University Health Sciences	Early Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Early Phase 1
University of North Carolina, Chapel Hill	Early Phase 1

See all PROAIR DIGIHALER clinical trials

Pharmacology for PROAIR DIGIHALER

Drug Class	beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists

US Patents and Regulatory Information for PROAIR DIGIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018		DISCN	Yes	No

Expired US Patents for PROAIR DIGIHALER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	6,748,947
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	7,540,282
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	10,765,820
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	6,718,972
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	8,006,690
Teva Branded Pharm	PROAIR DIGIHALER	albuterol sulfate	POWDER, METERED;INHALATION	205636-002	Dec 21, 2018	6,871,646

International Patents for PROAIR DIGIHALER

See the table below for patents covering PROAIR DIGIHALER around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2011254958
Brazil	112012029106
Canada	2799625
Canada	2887315
Canada	2936362
Canada	3019694

PROAIR DIGIHALER market dynamics and financial trajectory (U.S. asthma/COPD rescue inhaler)

Last updated: June 19, 2026

Executive summary: PROAIR DIGIHALER (albuterol sulfate) is a U.S. short-acting beta2-agonist (SABA) rescue inhaler positioned against legacy PROAIR HFA and generic albuterol HFA plus competing albuterol devices. Market growth is constrained by entrenched generic substitution, payer preference for lowest acquisition cost, and limited clinical differentiation versus other albuterol rescue inhalers. Financial trajectory is driven primarily by (1) share shift from older albuterol brands to device-enhanced formats, (2) volume effects from substitution and formulary churn, and (3) margin pressure as generics expand and net price discounts intensify. Without current Nielsen IQ/IMS revenue data and issuer financial disclosures tied specifically to “PROAIR DIGIHALER” (as opposed to the albuterol portfolio), no complete, accurate revenue trajectory can be stated.

What is PROAIR DIGIHALER and where does it fit in the asthma and COPD rescue inhaler market?

PROAIR DIGIHALER is a dose-controlled, device-assisted inhaled albuterol product used as a rescue bronchodilator in asthma. Albuterol SABAs remain a high-volume category where prescribing is stable but brands are exposed to substitution risk once generics are established and payers prefer lower-cost alternatives.

How does it compare with PROAIR HFA and other albuterol rescue inhalers?

In the U.S., the albuterol rescue landscape is crowded with:

• Generic albuterol HFA metered-dose inhalers (MDIs)
• Branded albuterol MDIs (legacy brands)
• Other device-specific albuterol formats and competing SABA inhalers

The practical market positioning of PROAIR DIGIHALER depends on:

• Whether payers view the device as reducing errors or improving adherence versus generic MDIs
• Whether retail pharmacy and PBM formularies grant preferred tier access
• Whether prescriber switching occurs beyond formulary-driven substitution

Which patient segments drive demand?

Demand is typically concentrated in:

• Asthma patients requiring SABA rescue use
• Patients with COPD needing rescue bronchodilation
• Patients who switch from older MDIs due to perceived usability benefits

How do PBM formulary rules and payer step edits shape PROAIR DIGIHALER sales?

SABA inhalers are commonly managed through:

• Tiering (preferred vs non-preferred)
• Quantity limits or claims editing
• Substitution policies at the pharmacy counter (brand-to-generic)

Even when a branded device is nominally differentiated, payer incentives usually favor the lowest-cost equivalent that meets substitution rules. Device features can matter for pharmacy benefit design, but PBM cost minimization typically dominates.

What tiering and discount dynamics typically occur for branded albuterol devices?

Common patterns across inhaler categories once generics dominate:

• Brand-to-generic substitution reduces volume
• Net pricing compresses due to laddered rebates and formulary placement costs
• Retail demand becomes more sensitive to PBM contracts and pharmacy benefit changes

What commercial levers determine net sales for PROAIR DIGIHALER?

Net sales are usually a function of:

• Formulary status (preferred tier access is critical)
• Contract renewals and rebate intensity
• Channel mix (commercial vs institutional vs government)
• Impact of patient assistance programs and copay cards (where applicable)

What market dynamics affect competition between PROAIR DIGIHALER and generic albuterol?

Generic albuterol HFA pricing and broad availability create structural headwinds for branded MDIs. A device-enhanced branded product can still win share, but usually only within limits set by:

• PBM substitution rules
• Prescriber behavior when a specific device is required
• Patient experience driven switching

Where can PROAIR DIGIHALER still gain share?

Share gains are most plausible when:

• Formularies keep the brand on preferred or at least non-excluded status
• Prescriber switching occurs due to usability or perceived technique improvement
• Pharmacy benefit design allows limited brand continuity for certain patients

What causes revenue volatility in SABA branded products?

Key volatility drivers:

• PBM contract renegotiations
• Tier changes
• Net-to-gross swings from rebate and discount adjustments
• Competitive entrants or LCM (life-cycle management) pressures from adjacent albuterol products

When does PROAIR DIGIHALER face exclusivity or patent-driven market entry risks?

A complete exclusivity and patent-timeline analysis requires current FDA exclusivity status and a contemporaneous Orange Book patent list for the specific strength and dosage form. No definitive timeline can be provided without the relevant Orange Book entries and their expiration dates.

Why exclusivity timelines matter for financial trajectory

For respiratory inhalers with long-established active ingredients, commercial outcome is mostly determined by:

• Patent estate strength for formulation, device, delivery, and method-of-use (where applicable)
• Exclusivity for reference product labeling changes (if any)
• Timelines for ANDA approvals and potential Paragraph IV litigation events

What is the Orange Book status of PROAIR DIGIHALER and which patents are listed for it?

A valid, accurate Orange Book status summary requires:

• The exact NDA number tied to PROAIR DIGIHALER
• The patent numbers and listed expiration dates for that NDA
• Any “patent drug” coding that differentiates strengths or dosage forms

No Orange Book data is available in the provided input, so no accurate patent listing can be reported.

How strong is the patent estate for PROAIR DIGIHALER versus competing albuterol inhalers?

Patent strength assessments depend on:

• Number of active patents at each jurisdiction
• Remaining enforceability windows
• Claim scope: formulation, device, manufacturing process, and use patents
• Litigation history and status

Without the active patent list and expiration dates for PROAIR DIGIHALER, a strength ranking cannot be produced.

Which companies challenge or compete against PROAIR DIGIHALER with generic or authorized alternatives?

Identifying challengers requires:

• ANDA filers tied to the relevant NDA in the Orange Book
• Paragraph IV notices and litigation dockets
• Authorized generic or branded “authorized alternatives” if any

No such dataset is provided, so competitor identification cannot be done accurately.

What formulation or device IP issues could block generic entry for PROAIR DIGIHALER?

Generic entry can be constrained when there are enforceable protections over:

• Device mechanics and dose delivery characteristics
• Particle engineering, spray characteristics, or valve/dose counter components
• Manufacturing process controls or stability specifications
• Labeling or method-of-use claims (less common for SABAs than for biologics or oncology, but possible where tied to specific therapeutic regimens)

A specific blocking-IP assessment requires the actual asserted or listed claims for PROAIR DIGIHALER.

What generic entry risks exist for PROAIR DIGIHALER under ANDA and Paragraph IV frameworks?

Generic risk is primarily determined by:

• How many ANDAs are “ready to launch” upon expiration
• Whether there are settlement agreements limiting launch dates
• Whether the branded product has ongoing litigation with stay provisions

No litigation or settlement dates are provided, so a generic launch-risk scenario cannot be stated.

How does PROAIR DIGIHALER compare with other SABA devices on usability, dosing conversion, and payer preference?

Where clinical difference is limited, market outcomes hinge on:

• Inhaler technique learning curve
• Device reliability (dose counter, feedback mechanisms)
• Training requirements at pharmacy and clinic
• Patient switching behavior

Commercial differentiation is possible if payers believe fewer administration errors reduce total pharmacy utilization or improve adherence. The extent of this effect is not quantifiable without observed market share, TRx, and payer claim pattern data.

What is the likely financial trajectory for PROAIR DIGIHALER given category maturity and substitution pressure?

Given category realities for albuterol SABAs:

• The branded “device-enhanced” segment tends to see slower growth or declining growth rates after generics strengthen and PBMs tighten tiering.
• Net sales usually compress first (pricing and rebates), then volume (share) follows when formularies shift.
• Any sustained growth usually depends on managed access: preferred formulary placement, contracted rebate structures that preserve net price, and clinician/patient stickiness to the device.

What financial metrics should be tracked to model trajectory?

To forecast and validate trajectory, the most decision-relevant metrics are:

• Rx volume (TRx) by month, distinguishing mail order vs retail
• Net price and rebate rate (net sales vs gross sales)
• Share vs the albuterol category total
• WAC-to-net ratio and PBM contract changes
• Claims-based patient persistence (time to discontinuation)

A quantified trajectory cannot be produced from the current input.

What settlement, litigation, or regulatory events could shift PROAIR DIGIHALER sales?

Material disruptions typically occur when:

• Paragraph IV litigation triggers a launch stay or settlement
• FDA safety or labeling changes alter patient eligibility or switching
• Device recalls or lot-specific distribution interruptions occur

No PROAIR DIGIHALER litigation or regulatory event timeline is provided here.

Key takeaways

• PROAIR DIGIHALER competes in a high-substitution SABA category where payer tiering and PBM economics usually dominate device differentiation.
• Market growth is constrained by generic albuterol penetration, pharmacy substitution incentives, and discount intensity.
• Financial trajectory is expected to be driven by formulary status, contract renewals, and net pricing compression.
• A precise exclusivity/patent and revenue trajectory cannot be stated without Orange Book/NDA patent data and current sales/claims datasets tied specifically to PROAIR DIGIHALER.

FAQs

1. How does PROAIR DIGIHALER typically maintain formulary access versus generic albuterol HFA?
2. What PBM contract levers most influence net sales for branded albuterol inhalers?
3. Which device-related features most affect patient switching between SABA inhalers?
4. How do settlement agreements in albuterol inhaler litigation change generic launch timing?
5. What claims metrics best predict whether PROAIR DIGIHALER share will decline after a competitor launch?

References

1. FDA Orange Book. Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drugs@FDA: FDA Approved Drug Products. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/