When do the ALBENZA patents expire, and when will ALBENZA go generic?

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax Labs Inc	ALBENZA	albendazole	TABLET;ORAL	020666-001	Jun 11, 1996		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: July 9, 2026

ALBENZA (albendazole) is a legacy antiparasitic with limited near-term US upside tied to (1) how many currently listed Orange Book patents truly constrain generic entry and (2) whether any FDA exclusivity protections still block ANDA launches. The investment case is therefore driven less by “brand science” and more by IP and regulatory timing, inventory-to-launch dynamics, and distributor pricing pressure typical for off-patent small molecules.

What is ALBENZA (albendazole) used for, who buys it, and what are core commercial drivers?

ALBENZA is an oral albendazole therapy used for parasitic infections, including (depending on FDA-approved labeling) indications such as cysticercosis and hydatid disease. Commercial demand tends to follow: (i) clinician diagnosis rates in endemic and travel-related cases, (ii) national treatment protocols, and (iii) the availability of alternative antiparasitics stocked in formularies.

Which formularies and channels matter most for albendazole products?

US channel exposure is typically concentrated in pharmacy benefits, hospital formularies (for heavier burden indications), and specialty/limited distribution where applicable.
Demand is sensitive to payer step edits and generic substitution at retail and wholesaler level.

What price and margin structure dominates for legacy antiparasitics?

Once generics are established, gross margin compresses primarily due to: wholesaler contract price pressure, retail DIR dynamics, and competitive shelf pricing.
Upside for branded “survivors” usually depends on: limited generic penetration in some package sizes, REMS-like controls (rare for albendazole), and durable IP or exclusivity that blocks an additional ANDA.

What patents protect ALBENZA in the US, and how many active Orange Book listings matter for generic entry?

The investment relevance is tied to Orange Book listings that are (a) “active” for the specific dosage form and strength and (b) supported by claims that can be asserted in an ANDA Paragraph IV framework.

How to evaluate the patent estate for ALBENZA

For a legacy small molecule, the estate typically includes:

composition-of-matter (rarely the binding limiter by the time the drug is old),
formulation/composition claims for specific dosage forms,
method-of-use claims for specific indications,
manufacturing/process claims (often weak for non-infringement defenses if ANDA uses a standard route),
pediatric exclusivity or other statutory exclusivity (not patents, but blocks certain generic approvals).

How many patents usually constrain ANDAs on older oral antiparasitics?

Investors should segment the Orange Book into “blocking” vs “non-blocking” listings:
- blocking: patents with expiration dates later than a generic’s proposed approval date and with claims plausibly cover the listed drug substance/strength.
- non-blocking: patents expiring earlier or not tied tightly to the ANDA-relevant product attributes (strength, dosage form, route).

Result required for a complete investment-grade analysis: exact Orange Book listings (US patents), listed strengths, expiration dates, and listed exclusivities are needed to compute calendar timing and litigation risk. Without the specific Orange Book dataset for ALBENZA in hand, a complete, accurate patent-count and expiration timeline cannot be produced.

When does ALBENZA lose exclusivity in the US (patent expiration and exclusivity timelines)?

For investment modeling, generic launch probability is primarily a function of:

the latest patent expiration among blocking Orange Book listings for the exact listed dosage form/strength, and
any relevant statutory exclusivity (notably pediatric exclusivity) that may delay ANDA approval even if patents expire.

Key timeline mechanics to model

“First generic approval date” under an ANDA typically depends on patent expiry and any exclusivity still in effect.
If a first Paragraph IV filer is eligible, 180-day exclusivity can shift market share timing even after other patents expire.

Result required for a complete investment-grade analysis: exact US patent expiration dates and any statutory exclusivity periods applicable to ALBENZA are required. Without the dataset, exclusivity “loses” timing cannot be stated accurately.

What generic entry risks exist for ALBENZA under ANDA Paragraph IV challenges?

For off-patent small molecules, the generic risk is usually high if:

there are no late-expiring blocking patents, and
the market already has multiple approved ANDAs, which reduces incremental market share capture risk.

How to assess Paragraph IV likelihood

Investors typically score:

how concentrated the Orange Book list is near-term,
whether the patents are formulation/method-of-use versus composition-of-matter,
historical behavior: how many ANDAs exist already, and whether prior challenges settled.

Result required for a complete investment-grade analysis: requires known Paragraph IV filings (FDA ANDA case numbers, notice letters, court filings, and settlement terms). Those specifics are not provided here, so a complete risk assessment cannot be produced.

How does ALBENZA compare with competing albendazole products and alternative antiparasitics?

Commercial substitution matters more than IP once generics are entrenched. A credible competitive view needs:

albendazole branded vs generic price spread by package size,
whether competing products are other benzimidazoles (e.g., mebendazole) or other antiparasitics used for similar indications,
payer formulary hierarchy.

What usually drives switching

clinical equivalence and safety profile familiarity,
package size and dosing convenience for prescribed duration,
payer coverage tier and patient copay.

Result required for a complete investment-grade analysis: requires actual current market product list and formulary/price dispersion for the relevant indications.

What is the Orange Book status of ALBENZA (listing-by-patent, strength-by-strength)?

An investment-grade Orange Book table typically includes:

Drug (listed product),
Dosage form/strength,
Active ingredient,
Patent number,
Patent expiration date,
Patent type (e.g., composition, method of use),
Exclusivity type (if applicable),
Relevant patents for ANDA blocking.

Result required for a complete investment-grade analysis: exact Orange Book table entries are necessary and cannot be derived from the prompt alone.

What formulation patents protect ALBENZA tablets/suspensions, and do they block non-infringing designs?

For oral small molecules, formulation patents sometimes protect:

specific excipient combinations,
particle size/solid-state properties,
manufacturing controls that affect bioavailability,
stability for shelf life.

Why formulation patents matter less if ANDA uses standard bioequivalence

Generics often match dissolution and bioavailability.
If formulation claims are narrow or depend on unique processing parameters, non-infringing designs become feasible.

Result required for a complete investment-grade analysis: the specific formulation patent numbers and claim scopes for ALBENZA are required.

What method-of-use patents for ALBENZA exist, and which indications are the enforcement targets?

Method-of-use patents can block an ANDA if the ANDA includes labeling that practices the claimed method.

How method-of-use risk is modeled

Does the ANDA seek “carve-out” labeling?
Does the brand enforce through labeling changes, injunction, or settlement restrictions?
Does the method-of-use claim map to standard dosing regimens already in generic label history?

Result required for a complete investment-grade analysis: needs method-of-use patent identifiers and the associated claimed regimens/indications.

What patent litigation affects ALBENZA, and what settlements constrain generic launches?

For branded legacy products, litigation can:

trigger “stay” periods,
lead to consent judgments that delay launches,
restrict label or dosage strength at launch.

What to include in an investment litigation model

case caption, court, docket,
asserted patents,
filing date of ANDA and notice date,
claim construction outcomes,
settlement payment and/or launch date covenants (where disclosed),
consent decree duration.

Result required for a complete investment-grade analysis: litigation and settlement facts for ALBENZA are not supplied in the prompt.

What is the FDA regulatory status of ALBENZA (approvals, labeling updates, and generic interchangeability)?

A fundamentals review requires:

current approved dosage forms,
whether any labeling changes were made in response to IP disputes,
whether “therapeutic equivalence” and generic interchangeability are widely established.

Result required for a complete investment-grade analysis: current FDA product status specifics and the active labeling version number are required.

How strong is the patent estate for ALBENZA in the long run?

For older molecules, the estate strength is often characterized as:

narrow, aging, or formulation-specific,
increasingly susceptible to non-infringement,
less likely to support extended market exclusivity beyond initial composition expiration.

Investment scoring framework for a legacy antiparasitic

Late-expiring patents: high scoring
Concentrated near-term exclusivity: high scoring
Numerous independent claims spanning the generic design space: high scoring
Weak claim-to-label mapping: low scoring
High probability of generic launch already realized historically: low incremental upside

Result required for a complete investment-grade analysis: a scored patent list with expiration dates and claim types is required.

Investment scenario: base case, bull case, and bear case for ALBENZA based on generic and exclusivity timelines

Because patent/exclusivity details are not provided, only a structure-level scenario map can be produced without making unsupported factual claims.

Bear case (high generic pressure)

Blocking patents are either already expired or not realistically enforceable.
Market share drifts to low-cost generics quickly after any incremental entry.
Revenue is resilient only through existing supply contracts and channel entrenchment.

Base case (stable branded economics)

Some Orange Book listings remain active but do not materially delay incremental competition beyond current baseline.
Any additional ANDA entrants face short delays due to remaining listings or minor labeling carve-outs.

Bull case (delayed entry and sustain pricing)

Late-expiring blocking patents and/or enforceable method-of-use claims constrain label and launch timing.
180-day exclusivity is triggered and maintains pricing for a defined period.

Result required for a complete investment-grade analysis: exact blocking patent expiration dates, exclusivity periods, and known ANDA/Paragraph IV activity to quantify these cases with dates and probabilities.

Key Takeaways

ALBENZA’s investment fundamentals are driven by IP and regulatory timing rather than novel clinical adoption.
The actionable variable is the set of Orange Book “blocking” patents and any statutory exclusivity that can delay ANDA approval or shape first-generic and 180-day exclusivity timing.
Without the specific Orange Book listing details, patent expiration calendar, and any ANDA Paragraph IV/litigation history, an investment-grade timing, strength score, or generic launch probability cannot be stated accurately.

FAQs

What Orange Book patents are listed for ALBENZA by strength and dosage form?
Are there any active Paragraph IV challenges or settlement agreements involving ALBENZA?
Does ALBENZA have any statutory exclusivity (including pediatric exclusivity) that delays generic ANDA approvals?
Which formulation or method-of-use patents, if any, can force labeling carve-outs for generic albendazole?
What are typical pricing and margin trajectories for branded oral antiparasitics once multiple albendazole ANDAs are on-market?

References

No sources were cited because the prompt does not include the Orange Book, FDA approval history, or litigation/Paragraph IV record required for an accurate patent- and exclusivity-based analysis of ALBENZA.

ALBENZA Drug Patent Profile

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Albenza

AI Deep Research

Questions you can ask:

Summary for ALBENZA

US Patents and Regulatory Information for ALBENZA

ALBENZA (albendazole): Investment scenario and fundamentals analysis for patent, exclusivity, regulatory risk, and generic launch economics