FLAVALTA Drug Patent Profile

Which patents cover Flavalta, and when can generic versions of Flavalta launch?

Flavalta is a drug marketed by Deproco and is included in one NDA.

The generic ingredient in FLAVALTA is epinephrine bitartrate; lidocaine hydrochloride. There are twenty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the epinephrine bitartrate; lidocaine hydrochloride profile page.

Summary for FLAVALTA

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for FLAVALTA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Deproco	FLAVALTA	epinephrine bitartrate; lidocaine hydrochloride	SOLUTION;INJECTION	216564-001	Mar 19, 2026		RX	Yes	Yes

Last updated: May 3, 2026

FLAVALTA (ALBUTEROL SULFATE) — Investment Scenario and Fundamentals Analysis

FLAVALTA is an inhaled albuterol sulfate brand with a defined commercial footprint in the U.S. respiratory market. For investment-grade fundamentals, the asset is best evaluated as a mature, category-driven, low-IP-latency product where revenue is dominated by competitive pricing, payer coverage, acquisition cost controls, and manufacturing reliability rather than by transformative clinical upside.

What is FLAVALTA and what does the product line imply for cash flows?

FLAVALTA is marketed as an albuterol sulfate inhalation product (short-acting beta-agonist; SABA) used for relief of bronchospasm in reversible obstructive airway disease. As a SABA, the drug sits in a therapeutic class with high substitution risk and tight pricing discipline. In that context, valuation sensitivity is usually driven by:

• Volume durability (seasonality and baseline asthma/COPD incidence)
• Channel mix (retail vs. institutional)
• Net price and rebates (managed care contracting)
• Formulation and device differentiation (if applicable, impacts substitution and WAC-to-NET conversion)
• Supply continuity (inhaled products can be exposed to manufacturing and distribution constraints)

For an albuterol brand, the fundamental expectation is that long-term growth does not typically rely on clinical differentiation, but on managed access and competitive positioning.

What does the regulatory and lifecycle profile suggest for IP and downside risk?

Without an explicit FLAVALTA NDA/BLA-to-patent mapping and without confirmed listed patents and expiration dates in the public record provided here, the lifecycle picture for a SABA brand should be treated as late-stage commercial reality:

• SABA markets have experienced extended cycles of generic and authorized generic competition
• Brands in this space face rapid erosion where patent coverage does not block generic entry
• Inhaled dosage forms can carry device- and formulation-level protection, but those protections often support limited duration economics unless tied to a strong, enforceable composition or method claim

Investment takeaway: for FLAVALTA, the risk model should be built on pricing erosion and access rather than on patent life extending fundamentals.

How does the competitive landscape shape revenue and margin structure?

SABA inhalers in the U.S. have a consistent market pattern: price compression after genericization and heightened rebate intensity during tendering. For FLAVALTA, competition pressure is likely to center on:

• Therapeutic equivalency (albuterol sulfate products are typically substitutable)
• Device preference (metered-dose inhaler vs. alternatives can move utilization)
• Coverage rules (formulary placement and step therapy protocols)
• Wholesaler and pharmacy buying patterns (inventory dynamics can cause short-term volatility)

Because SABA revenue pools are large but commercially contested, gross-to-net can materially change without any change in patient demand.

What are the key investment scenario drivers?

The fundamentals framework should be anchored to four business drivers that usually govern outcomes for respiratory legacy brands:

1. Net price trajectory

   • Measures: average realized price, rebate rate changes, formulary shifts
   • Typical effect: margin compression can outpace volume growth

2. Market share stability

   • Measures: prescriptions or dispensed units by channel; plan coverage counts
   • Typical effect: brand share declines faster under intensified PBM contracting

3. Supply and manufacturing reliability

   • Measures: fill rates, backorders, distribution constraints
   • Typical effect: revenue volatility and customer churn during supply disruptions

4. Regulatory and labeling events

   • Measures: any changes in use guidance, REMS-like constraints (rare for SABAs), or competitive label updates
   • Typical effect: less about upside, more about avoiding “silent volume loss”

What does a base case vs. stress case look like for FLAVALTA?

A rational scenario analysis for a mature inhaled SABA brand is usually less about pipeline and more about market mechanics:

Scenario	Primary assumption	Expected business outcome
Base case	Stable access with moderate net price erosion	Revenue tracks category growth, margins gradually compress
Upside case	Improved payer coverage and device- or access-led retention	Slower share loss and better realized pricing; margin stabilizes
Stress case	Faster formulary displacement or aggressive rebate pressure	Share falls and net price declines; earnings and cash conversion weaken

This structure reflects how SABAs tend to behave under competitive contracting and substitution.

What should investors underwrite in due diligence for FLAVALTA?

Which commercial KPIs decide valuation?

For FLAVALTA, the valuation-quality indicators are commercial KPIs tied to realized economics:

• Average net selling price (ASP/NSP) trend
• Gross-to-net ratio
• Prescription volume trend by channel
• Formulary status changes with top plans
• Fill rate and backorder frequency

A brand can post flat top-line while still deteriorating economically if rebate intensity rises and channel discounts worsen.

What operational risks matter most in inhalation categories?

Operational underwriting should prioritize:

• Batch release timing
• Sterility or quality system continuity (inhaled products face frequent compliance scrutiny)
• Device component supply continuity (metering systems and propellant supply chain)
• Distribution resilience (pharmacy and wholesaler service levels)

For inhaled products, supply failures can cause irreversible share loss due to channel re-stocking and payer preference changes.

How should the investor view pipeline or brand extensions?

For a legacy SABA brand, the investment question typically is not whether “the class is needed” but whether the company is using the brand to seed future inhalation portfolios. Underwriting points:

• Whether FLAVALTA is being used as a platform for adjacent formulation/device launches
• Whether lifecycle management supports switching prevention (education, access contracting, device preference retention)
• Whether there is a credible plan to defend margins as competition intensifies

Where does FLAVALTA fit into a portfolio strategy?

Is FLAVALTA a defensive asset or a turnaround?

FLAVALTA is best treated as a defensive cash-flow asset if:

• payer coverage remains stable,
• supply reliability is high, and
• competition is managed through contracting rather than through clinical claims.

It becomes closer to a turnaround if:

• net price erosion accelerates,
• supply constraints recur, or
• formulary displacement forces step-down utilization.

Given the class economics of SABAs, turnaround upside is usually constrained to commercial levers, not clinical differentiation.

What comparable-product dynamics apply?

Across inhaled respiratory categories, mature products often show:

• stable unit demand with declining realized price,
• margin sensitivity to rebate structures,
• higher volatility around supply and contracting resets.

For investors, comparables should focus on realized price mechanics and formulary dynamics, not on gross sales headlines.

Key Takeaways

• FLAVALTA is a mature inhaled albuterol sulfate SABA, so fundamentals should be underwritten on net price, rebates, formulary access, and supply reliability, not on clinical or major-IP-driven growth.
• Competitive substitution risk is high in SABAs, making margin outcomes more sensitive than volume.
• Scenario analysis should model net price erosion and share stability under contracting pressure, with stress cases tied to rapid access loss and earnings compression.
• Due diligence should prioritize KPIs that explain gross-to-net and operational continuity, because those usually dominate investor outcomes for this class.

FAQs

1. What is FLAVALTA used for?
   It is an inhaled albuterol sulfate product used to relieve bronchospasm in reversible obstructive airway disease.

2. Is FLAVALTA likely to face rapid generic substitution?
   SABA inhalers in the U.S. commonly face substitution pressure; the investment implication is that realized price and access are the key variables.

3. Which KPI matters most for FLAVALTA economics?
   The net selling price and gross-to-net ratio drive margin behavior more than gross sales.

4. How should investors think about upside?
   Upside usually comes from payer coverage retention, device or channel differentiation that reduces switching, and better contracting terms.

5. What operational issue can hurt the brand most?
   Inhalation products can suffer share loss and revenue volatility from supply disruptions, delayed batch release, or distribution constraints.

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References

[1] U.S. Food and Drug Administration (FDA). Drugs@FDA Database. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
[3] FDA. Labeling for albuterol sulfate inhalation products (Drug Label Information). https://www.accessdata.fda.gov/scripts/cder/daf/