ALBENZA Drug Patent Profile

Which patents cover Albenza, and what generic alternatives are available?

Albenza is a drug marketed by Impax Labs Inc and is included in one NDA.

The generic ingredient in ALBENZA is albendazole. There is one drug master file entry for this compound. Ten suppliers are listed for this compound. Additional details are available on the albendazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Albenza

A generic version of ALBENZA was approved as albendazole by ZYDUS PHARMS on December 14^th, 2018.

Summary for ALBENZA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	126
Clinical Trials:	3
Patent Applications:	4,462
Drug Prices:	Drug price information for ALBENZA
What excipients (inactive ingredients) are in ALBENZA?	ALBENZA excipients list
DailyMed Link:	ALBENZA at DailyMed

See drug prices for ALBENZA

Recent Clinical Trials for ALBENZA

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

Sponsor	Phase
Lihir Medical Centre	Phase 3
Swiss Tropical & Public Health Institute	Phase 3
Institut de Recherche Clinique du Bénin (IRCB)	Phase 3

See all ALBENZA clinical trials

Pharmacology for ALBENZA

Drug Class	Anthelmintic
Mechanism of Action	Cytochrome P450 1A Inducers

US Patents and Regulatory Information for ALBENZA

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

Albenza Market Dynamics and Financial Trajectory

Last updated: August 3, 2026

Albenza, the U.S. brand for albendazole, is an established antiparasitic drug with durable clinical demand but limited patent protection. Its commercial economics have historically depended less on exclusivity than on restricted generic supply, manufacturing constraints, public-health procurement, and high U.S. pricing. The core composition patent estate is expired or commercially immaterial. Future erosion risk is therefore driven by additional approved manufacturers, purchasing controls, and supply normalization rather than by a near-term loss of patent protection.

What is Albenza and how is it used?

Albenza contains albendazole, a benzimidazole anthelmintic approved in the United States as a prescription tablet.

Attribute	Albenza profile
Active ingredient	Albendazole
U.S. dosage form	200 mg tablet
U.S. application	NDA 020666
FDA approval	1996
Therapeutic category	Anthelmintic and antiparasitic
Main indications	Neurocysticercosis and hydatid disease
Prescription status	Prescription-only
Biologic status	Not a biologic
Biosimilar pathway	Not applicable
Primary commercial constraint	Limited supply and generic competition
Primary patent risk	Low relative to supply and pricing risk

The FDA-approved U.S. label covers neurocysticercosis caused by larval forms of Taenia solium and hydatid disease caused by larval forms of Echinococcus granulosus. Albendazole is also widely used internationally for other parasitic infections, including soil-transmitted helminths, although U.S. labeling does not cover every global use.[1]

Albenza is generally administered in short courses. That limits the number of tablets used per patient but can produce a high cost per treatment course when the U.S. price is calculated on a cash or list-price basis.

How large is the U.S. Albenza market?

The U.S. market is a specialty anti-infective niche rather than a high-volume chronic-care market. Demand is episodic and concentrated in several channels:

1. Hospital and specialty pharmacy prescriptions.
2. Infectious-disease and neurology treatment.
3. Government and public-health programs.
4. Travel and immigrant-health programs.
5. International humanitarian and mass-drug-administration programs, usually supplied through non-U.S. channels.

Volume is constrained by the relatively low incidence of labeled U.S. indications. Revenue has nevertheless been supported by high unit pricing and the absence, for long periods, of consistent generic competition.

Public prescription datasets do not provide a complete measure of Albenza economics because they can exclude hospital purchasing, government contracts, rebates, specialty-pharmacy discounts, and international sales. Gross prescription revenue therefore overstates the manufacturer’s net revenue.

What factors drive Albenza demand?

Demand is relatively insensitive to ordinary consumer marketing because albendazole is prescribed for diagnosed or strongly suspected parasitic disease. The principal demand variables are:

• Neurocysticercosis diagnosis rates.
• Hydatid disease treatment.
• Immigration and refugee-health programs.
• Outbreaks and public-health campaigns.
• Availability of competing anthelmintics.
• Physician substitution between albendazole and mebendazole.
• Government procurement and foreign aid programs.

The drug’s short treatment duration reduces recurring prescription volume. It also makes supply interruptions operationally important because alternative products may not be immediately available for a specific indication or patient population.

What is the financial trajectory for Albenza?

Albenza’s financial trajectory has been characterized by low-to-moderate volume, high price per tablet, and revenue volatility tied to supply and competition.

Historical U.S. pricing attracted scrutiny after major increases in the price of branded albendazole. Public reporting documented a rise from a low single-digit per-tablet price to more than $200 per tablet during the period when the product was sold by Amedra Pharmaceuticals.[2] The increase created substantial gross-revenue potential despite the drug’s narrow market.

That pricing model has three limits:

• Payers can impose prior authorization and quantity controls.
• Hospitals and government purchasers negotiate below list price.
• New generic approvals can reduce both volume and net price.
• Physicians and pharmacies can substitute when an alternative is available.

The relevant financial metric is therefore not the retail price but net sales after rebates, chargebacks, government discounts, specialty-pharmacy concessions, and inventory adjustments.

How does Albenza revenue compare with the cost of treatment?

A typical labeled course may require only a small number of 200 mg tablets, but list-price treatment costs can be disproportionately high. This creates a large gap between:

• Manufacturing cost per tablet.
• Wholesale acquisition cost.
• Pharmacy reimbursement.
• Patient out-of-pocket expense.
• Manufacturer net revenue.

Albendazole is a mature small molecule. Its active pharmaceutical ingredient is not generally associated with the technical complexity of a biologic or a high-potency oncology product. The commercial price has therefore reflected market structure more than production cost.

What is the revenue outlook?

The likely revenue path is gradual erosion rather than an abrupt patent cliff.

Period	Expected commercial condition
Historical branded period	High pricing supported by limited competition
Generic-entry period	Lower prices and payer substitution
Supply-constrained period	Temporary price and volume support for available suppliers
Normalized-competition period	Reduced net price, greater formulary pressure
Long term	Stable niche demand with lower unit economics

The strongest downside scenario involves two or more reliable generic suppliers with consistent wholesaler inventory. The most favorable scenario for the brand involves continued generic shortages, limited manufacturer participation, and sustained demand from specialty and public-health channels.

Public company filings generally do not isolate Albenza as a standalone revenue line in a way that permits a reliable multi-year earnings series. Analysts should avoid treating total company revenue or reported product-portfolio revenue as Albenza sales.

What patents protect Albenza?

The original patent protection for albendazole is no longer the principal commercial barrier. Albendazole was discovered and developed decades ago, and the composition-of-matter exclusivity associated with the active ingredient has expired.

The relevant protection categories are:

Protection category	Current commercial significance
Albendazole composition patent	Expired
Original formulation protection	Expired or no longer commercially decisive
New indication patents	Limited relevance to the core U.S. product
Manufacturing patents	Potentially relevant but difficult to use against ordinary tablet competition
Regulatory exclusivity	Expired
Trade secrets and know-how	Possible operational value, not a classic market-exclusion right

A patent number-by-patent-number conclusion requires a current Orange Book and USPTO review tied to the applicable NDA and listed patents. The key business conclusion is clear: Albenza does not have a durable, enforceable composition patent blocking ordinary albendazole tablets.

What is the Orange Book status of Albenza?

Albenza is associated with FDA NDA 020666. The Orange Book is the controlling source for listed patents, therapeutic-equivalence codes, and approved reference-product information.[3]

For market-access analysis, the important points are:

• Albenza is an approved reference product.
• Any current Orange Book patents must be reviewed against the latest listing record.
• Expired patents do not prevent ANDA approval or generic launch.
• A generic applicant may rely on Paragraph III, Paragraph IV, or another applicable certification depending on the listed patent record.
• The absence of an unexpired blocking patent does not guarantee immediate generic supply.

FDA approval and commercial availability are separate events. A company may obtain approval but delay launch because of manufacturing scale, product liability exposure, low expected margins, wholesaler requirements, or supply-chain constraints.

When did Albenza lose exclusivity?

Albenza lost meaningful market exclusivity years ago. Its FDA approval dates to 1996, and any standard five-year new chemical entity exclusivity expired no later than 2001. Any remaining three-year exclusivity tied to a qualifying supplemental approval would also have expired long ago.

The product’s practical exclusivity lasted longer than its legal exclusivity because few manufacturers entered the U.S. market. That distinction is central to Albenza’s economics.

Exclusivity mechanism	Status
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not the principal basis of current protection
Pediatric exclusivity	No current commercial effect
Composition patent	Expired
Formulation patent	No known durable barrier to ordinary tablet competition
Market-based exclusivity	Historically created by limited supply

Which companies are challenging Albenza?

Generic albendazole manufacturers and applicants have been the principal source of competitive pressure. Publicly available FDA drug databases identify approved albendazole tablet products from manufacturers other than the brand holder, although availability has varied by time and market.

The competitive set can include:

• Approved ANDA holders.
• Contract manufacturers supplying generic applicants.
• International albendazole producers.
• Mebendazole manufacturers competing on indication and prescriber preference.
• Other anthelmintics used for narrower clinical situations.

A Paragraph IV challenge is legally relevant only if an applicant certifies that a listed patent is invalid, unenforceable, or not infringed. Because the core albendazole patent estate is old, the principal launch question has been commercial readiness rather than patent litigation.

No major, industry-defining Albenza patent settlement is central to the product’s current market narrative. Generic entry has been more closely associated with approval timing, supply availability, and pricing than with a high-value patent settlement.

What is the FDA regulatory status of Albenza?

Albenza remains an FDA-approved prescription product for its labeled indications. Albendazole is also listed in FDA and public-health discussions involving supply constraints and limited availability of certain antiparasitic products.[4]

The FDA pathway for a competing conventional tablet is an ANDA demonstrating pharmaceutical equivalence and bioequivalence to the reference product. A generic manufacturer does not need to repeat the full clinical development program required for an original NDA.

Regulatory risks include:

• Product shortages.
• Manufacturing-site changes.
• API sourcing problems.
• Quality-control failures.
• Labeling and packaging requirements.
• Limited commercial incentives for a low-volume product.
• Wholesale distribution constraints.

The shortage risk is commercially important because even an approved generic does not provide effective competition if pharmacies cannot obtain it consistently.

What generic entry risks exist for Albenza?

Generic entry risk is high in legal terms and moderate in practical terms.

Legal risk

The absence of meaningful unexpired composition protection permits generic approval and launch, subject to the applicable Orange Book certifications and regulatory requirements.

Commercial risk

The commercial threat depends on whether the generic can:

• Secure a reliable albendazole API supply.
• Manufacture at acceptable cost.
• Obtain national wholesaler distribution.
• Support uninterrupted pharmacy inventory.
• Compete with branded contracts and rebates.
• Maintain product availability during demand spikes.

A single generic entrant may reduce price without eliminating the brand. Several reliable entrants can materially compress net revenue and increase payer substitution.

Launch scenarios

Scenario	Market effect
Generic approval without launch	Minimal immediate impact
One reliable generic	Moderate price and share pressure
Multiple reliable generics	Significant net-price erosion
Generic shortage	Brand retains share and pricing power
Brand supply interruption	Rapid prescription substitution
Government bulk procurement	Lower price, higher volume potential

How strong is the Albenza patent estate?

The Albenza patent estate is weak as a long-term exclusivity asset but may retain limited value in documentation, formulation know-how, manufacturing controls, and brand recognition.

Dimension	Assessment
Composition patent strength	Low; expired
Remaining patent term	Low
Litigation leverage	Low
Regulatory moat	Low
Manufacturing moat	Moderate if supply is difficult to reproduce
Brand recognition	Moderate in specialist channels
Pricing power	Dependent on competition and shortages
Long-term defensibility	Limited

The strongest barrier is operational rather than legal. A manufacturer with dependable supply can preserve share even without patent protection. Conversely, a patent-free market can remain concentrated if expected returns are too small to attract multiple suppliers.

How does Albenza compare with mebendazole?

Albendazole and mebendazole are both benzimidazole anthelmintics, but they have different U.S. commercial profiles.

Factor	Albenza	Mebendazole
Active ingredient	Albendazole	Mebendazole
U.S. brand	Albenza	Emverm, historically Vermox in some markets
Main U.S. uses	Neurocysticercosis and hydatid disease	Several intestinal helminth infections
Treatment pattern	Often short-course specialty use	Often short-course outpatient use
Patent position	Mature and largely expired	Product-specific, with historical formulation protection
Market exposure	Specialty and hospital demand	Primary care, infectious disease, and public-health demand
Substitution	Clinically dependent on indication	Clinically dependent on indication
Supply risk	Material	Also material, depending on product

Mebendazole is not a complete substitute for albendazole in every labeled indication. A payer’s ability to switch products depends on diagnosis, dosing, tolerability, physician preference, and availability.

What licensing deals and ownership changes affect Albenza?

Albenza has passed through multiple commercial ownership arrangements involving large and specialty pharmaceutical companies. Historical commercialization included GlaxoSmithKline, followed by specialty-pharmaceutical ownership associated with Amedra and later portfolio transactions.

These transactions matter because Albenza has generally been managed as a mature portfolio product rather than as a discovery-stage asset. The value proposition is cash flow from an established product, not pipeline optionality.

Deal economics can include:

• Upfront consideration.
• Milestone payments.
• Inventory transfers.
• Manufacturing and supply agreements.
• Assumption of regulatory obligations.
• Rights to U.S. or international territories.

Public disclosures do not consistently provide a standalone valuation for Albenza. Product-level financial conclusions should therefore rely on disclosed portfolio data only when the filing clearly identifies Albenza revenue.

What patent litigation affects Albenza?

Albenza has not developed the litigation profile associated with high-value oncology, autoimmune, or specialty biologic products. The principal disputes and commercial pressures have involved pricing, access, supply, and generic availability rather than a sustained campaign around a valuable remaining patent estate.

The absence of prominent litigation does not eliminate launch risk. Generic applicants may still face:

• Orange Book certification disputes.
• Manufacturing or quality disputes.
• Contract and distribution claims.
• State pricing investigations.
• Product-liability exposure.
• Regulatory enforcement related to supply or labeling.

The litigation risk is therefore secondary to regulatory and commercial execution.

What geographic markets matter for albendazole?

The U.S. market has unusually high revenue per treatment course but relatively low population volume. International markets have much larger public-health demand and lower pricing.

Geography	Commercial profile
United States	High unit price, specialty prescriptions, payer controls
Europe	More price regulation and generic substitution
Latin America	Broad antiparasitic use and competitive local supply
Africa	Large public-health demand, donor and government procurement
South Asia	High production capacity and lower price points
Global humanitarian market	Volume-driven, tender-based economics

Albendazole is included in mass-drug-administration programs for soil-transmitted helminths and lymphatic filariasis. These programs can generate significant global volume but do not necessarily produce U.S.-style branded margins.[5]

Key Takeaways

• Albenza is a mature albendazole product approved under NDA 020666.
• Its original patent and regulatory exclusivity have expired.
• The current commercial moat is supply reliability, not patent protection.
• U.S. pricing has historically been high relative to manufacturing cost and treatment duration.
• Generic entry risk is substantial, but actual erosion depends on the number and reliability of suppliers.
• No biosimilar pathway applies because albendazole is a small-molecule drug.
• Public-health and international demand support volume but generally at lower prices.
• Product-level Albenza revenue is not consistently disclosed, limiting precise standalone valuation.
• The most important forward indicators are Orange Book listings, ANDA approvals, FDA shortage status, wholesaler inventory, and net-price trends.

FAQs About Albenza Market and Patent Risk

Is Albenza still protected by a patent?

The original albendazole composition protection has expired. Any current patent issue would need to arise from a specific later formulation, method-of-use, or manufacturing patent listed for the reference product.

Can a generic manufacturer launch albendazole without a Paragraph IV challenge?

Yes. If no unexpired blocking patent requires a Paragraph IV certification, an applicant may use another applicable certification. Patent certification depends on the current Orange Book record.

Why has Albenza remained expensive after patent expiration?

Limited generic participation, supply constraints, specialty distribution, payer contracting, and the small size of the U.S. market have supported pricing after legal exclusivity ended.

Is albendazole manufactured in the United States?

The finished product and active ingredient may involve international manufacturing and supply chains. The relevant commercial issue is FDA-compliant availability of the finished tablet and API, not the location of every production step.

Does Albenza have blockbuster revenue potential?

The product is unlikely to achieve conventional blockbuster scale from U.S. prescriptions alone. Its value is based on niche, high-price revenue and global public-health volume rather than broad chronic-use demand.

References

1. U.S. Food and Drug Administration. (2023). Albenza (albendazole) tablets, 200 mg: Prescribing information.
2. U.S. Senate Committee on Homeland Security and Governmental Affairs. (2018). Skyrocketing prescription drug prices: Perspectives from the pharmaceutical industry.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, Orange Book.
4. U.S. Food and Drug Administration. (2024). Drug shortages: Albendazole tablets.
5. World Health Organization. (2023). Preventive chemotherapy to control soil-transmitted helminth infections in at-risk population groups.