List of Excipients in Branded Drug ALBENDAZOLE

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Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Amneal Pharmaceuticals of New York LLC	ALBENDAZOLE	albendazole	0115-1701	CARNAUBA WAX
Amneal Pharmaceuticals of New York LLC	ALBENDAZOLE	albendazole	0115-1701	CELLULOSE, MICROCRYSTALLINE
Amneal Pharmaceuticals of New York LLC	ALBENDAZOLE	albendazole	0115-1701	HYPROMELLOSES
Amneal Pharmaceuticals of New York LLC	ALBENDAZOLE	albendazole	0115-1701	LACTOSE MONOHYDRATE

Generic Drugs Containing ALBENDAZOLE

Company	Ingredient	NDC	Excipient
Actavis Pharma Inc	albendazole	0591-2712	CELLULOSE, MICROCRYSTALLINE
Actavis Pharma Inc	albendazole	0591-2712	HYPROMELLOSES
Actavis Pharma Inc	albendazole	0591-2712	LACTOSE MONOHYDRATE
Actavis Pharma Inc	albendazole	0591-2712	MAGNESIUM STEARATE

What are the Most Frequently-Used Excipients in ALBENDAZOLE?

# Of NDCs	Excipient
5	CARNAUBA WAX
15	CELLULOSE, MICROCRYSTALLINE
5	CROSCARMELLOSE SODIUM
1	HYPROMELLOSE

Albendazole Excipient Strategy and Commercial Opportunities

Last updated: October 7, 2026

Albendazole’s main formulation problem is poor aqueous solubility and variable oral exposure. The strongest commercial opportunities are improved pediatric dosage forms, rapid-dissolution tablets, dispersible products, and enabling formulations that reduce dependence on high-fat meals. Albendazole has limited originator patent protection, no biosimilar pathway, and a largely generic competitive structure. Product differentiation therefore depends on formulation performance, procurement access, regulatory positioning, and manufacturing cost.

What is the formulation challenge for albendazole?

Albendazole is a benzimidazole anthelmintic used against intestinal helminths and tissue infections. Its active metabolite, albendazole sulfoxide, drives systemic activity in indications such as neurocysticercosis and hydatid disease. The parent drug has low aqueous solubility, which limits dissolution and creates variable exposure after oral administration.

Food has a material effect on exposure. The U.S. prescribing information reports that a high-fat meal increases albendazole sulfoxide exposure compared with fasting administration, making dose administration conditions clinically relevant for systemic infections (FDA, 2023).

The formulation targets are therefore:

1. Increase apparent solubility and dissolution rate.
2. Reduce food-dependent variability.
3. Improve administration in children and patients with swallowing difficulty.
4. Preserve chemical stability during storage.
5. Maintain low cost for mass-deworming programs.
6. Avoid excipients that create regulatory or supply-chain barriers in low- and middle-income countries.

Which excipients are suitable for albendazole formulations?

The preferred excipient system depends on the product objective. A low-cost tablet for intestinal infections requires a different design from a high-performance pediatric suspension or a systemic formulation for neurocysticercosis.

Formulation objective	Suitable excipient classes	Commercial rationale
Basic immediate-release tablet	Lactose, maize starch, microcrystalline cellulose, povidone, sodium starch glycolate, crospovidone, magnesium stearate	Low cost and established regulatory history
Rapid-dissolution tablet	Crospovidone, croscarmellose sodium, sodium starch glycolate, wetting agents	Improves disintegration and dissolution
Wetting enhancement	Sodium lauryl sulfate, poloxamers, polysorbates	Reduces interfacial resistance and improves drug wetting
Amorphous solid dispersion	Hydroxypropyl methylcellulose, hypromellose acetate succinate, povidone, copovidone, Soluplus-type polymers	Raises apparent solubility and may improve exposure
Lipid-based formulation	Medium-chain triglycerides, long-chain glycerides, polysorbates, lecithin, mixed surfactants	Supports dissolution of a lipophilic drug
Nanosuspension	Poloxamer 188, polysorbate 80, povidone, cellulose derivatives	Increases surface area and dissolution rate
Pediatric suspension	Xanthan gum, sodium carboxymethylcellulose, hydroxyethylcellulose, sucrose, sorbitol, glycerol	Supports dose uniformity, palatability, and redispersibility
Orodispersible or chewable tablet	Mannitol, crospovidone, microcrystalline cellulose, sucralose, flavoring agents	Improves administration without water
Dispersible tablet	Lactose, mannitol, crospovidone, croscarmellose sodium, flavoring agents	Suits pediatric and public-health use

Excipient selection must account for the target market. Lactose and sucrose can create restrictions for selected patient populations, while sorbitol and other polyols can cause gastrointestinal intolerance at high exposure. Sodium lauryl sulfate improves wetting but can create taste, irritation, and compatibility concerns. Surfactant concentration should be minimized while maintaining dissolution performance.

What excipients are used in approved albendazole tablets?

The U.S. Albenza label identifies conventional tablet excipients including colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, sodium lauryl sulfate, sodium starch glycolate, and povidone (FDA, 2023). This composition reflects a conventional immediate-release strategy rather than a proprietary high-solubility platform.

The commercial implication is important. A new product using the same general excipient architecture will usually have limited differentiation unless it demonstrates:

• Faster dissolution.
• Better dose uniformity after dispersion.
• Improved stability.
• Better taste masking.
• Lower tablet size.
• Reduced food effect.
• Easier pediatric administration.
• Lower manufacturing cost.

What formulation platforms offer the strongest commercial opportunity?

Amorphous solid dispersions

Amorphous solid dispersions can improve apparent solubility by embedding albendazole in a polymeric matrix. Hypromellose, povidone, copovidone, and hypromellose acetate succinate are potential carrier polymers.

The primary risks are recrystallization, moisture sensitivity, polymer-drug miscibility, and scale-up. A solid dispersion may also require specialized hot-melt extrusion or spray-drying equipment. That increases manufacturing cost relative to a conventional tablet.

The opportunity is strongest where systemic exposure is commercially important, including neurocysticercosis and hydatid disease. For single-dose intestinal indications, the price premium may not justify the process complexity.

Nanosuspensions

Nanosuspensions reduce particle size and increase surface area without requiring complete molecular solubilization. Stabilizers such as poloxamers, povidone, and polysorbates can limit aggregation.

A nanosuspension can be packaged as an oral liquid, reconstitutable powder, or solidified intermediate. Its principal risks are particle growth, sedimentation, microbial control, redispersibility, and scale-up consistency.

Nanosuspensions are commercially relevant for pediatric dosing and for patients unable to swallow tablets. A reconstitutable powder may offer better stability and lower transport weight than a ready-to-use liquid.

Lipid-based systems

Lipid-based formulations may improve albendazole dissolution by maintaining the drug in a solubilized state after administration. Medium-chain triglycerides, long-chain glycerides, lecithin, and nonionic surfactants are candidate components.

The main technical barrier is precipitation after dilution in gastrointestinal fluid. A formulation that appears highly soluble in the capsule or liquid vehicle may release albendazole when exposed to bile salts and intestinal fluid. In vitro dispersion and precipitation testing is therefore central to development.

Lipid systems have a stronger commercial case for systemic indications than for mass deworming, where cost, storage, and simple administration are more important.

Chewable and dispersible tablets

Chewable and dispersible tablets are among the most practical opportunities. Albendazole is already used extensively in children, and standard tablets may be difficult to swallow or require crushing. A palatable dosage form can improve administration without requiring a complex bioavailability platform.

Mannitol, microcrystalline cellulose, crospovidone, croscarmellose sodium, sweeteners, and flavors are common starting points. Taste masking is a major development issue because albendazole has an unpleasant taste profile. Coated granules, polymeric taste-masking layers, ion-exchange resins, and lipid barriers can be evaluated.

For public-health tenders, the product must combine low unit cost, rapid disintegration, acceptable taste, and packaging suitable for heat and humidity.

What FDA regulatory status does albendazole have?

Albendazole is FDA-approved as an oral anthelmintic. The U.S. reference product is Albenza, supplied as 200 mg tablets. Approved indications include neurocysticercosis caused by larval forms of Taenia solium and hydatid disease caused by larval forms of Echinococcus granulosus (FDA, 2023).

The FDA product profile creates several regulatory pathways:

Product type	Likely regulatory route	Key development issue
Conventional 200 mg tablet	Abbreviated New Drug Application	Bioequivalence and dissolution
Chewable tablet	ANDA or 505(b)(2), depending on reference and formulation	Taste, in-use performance, bioequivalence
Oral suspension	ANDA or 505(b)(2)	Dose uniformity, stability, bioequivalence
Novel enabling formulation	505(b)(2) or full application	Exposure, food effect, clinical bridging
Pediatric dispersible product	ANDA or 505(b)(2)	Dose accuracy and administration instructions

An improved formulation that changes exposure, food dependence, or the dosing regimen may face a more complex regulatory program than a conventional generic. A 505(b)(2) strategy can be commercially attractive when the formulation provides a meaningful clinical or administration advantage but cannot rely entirely on a conventional ANDA pathway.

What is the Orange Book and patent status of albendazole?

Albendazole’s originator exclusivity is no longer the main commercial barrier. The product is available in generic form, and competition is driven primarily by manufacturing economics, regulatory approvals, procurement contracts, and formulation execution.

The FDA Orange Book must be reviewed for the current reference-listed product, approved applications, and any active patent or exclusivity listings. Albendazole’s commercial opportunity is generally not based on blocking generic entry through legacy composition-of-matter protection. A new formulation would need to establish its own protection through formulation, process, dosage-form, or method-of-use claims.

Potential patentable features include:

• Specific particle-size distributions.
• Amorphous albendazole compositions.
• Polymer-drug ratios in solid dispersions.
• Nanosuspension stabilizer systems.
• Taste-masked granules.
• Reconstitutable pediatric suspensions.
• Moisture-resistant packaging and formulation combinations.
• Manufacturing processes that limit recrystallization.
• Dosing methods that reduce food-related exposure variability.

Patent strength will depend on whether the claims cover a technically necessary formulation feature or merely a broad list of known excipients. A claim directed to a defined dissolution profile, particle-size range, stability threshold, or polymer ratio is generally more defensible than a generic claim covering albendazole with an unspecified solubilizer.

When does albendazole lose exclusivity?

The principal small-molecule exclusivity period has expired. Albendazole is therefore exposed to generic competition in the United States and other major markets.

The relevant commercial question is not when the original molecule loses exclusivity, but whether a new formulation can obtain independent protection. New patents may delay direct substitution only if they are listed or otherwise enforceable against the relevant product and survive validity challenges.

There is no biosimilar risk because albendazole is a synthetic small molecule, not a biologic. Competitive risk comes from:

• Conventional generic tablets.
• Low-cost international manufacturers.
• Compounded or extemporaneous liquids.
• Alternative benzimidazoles such as mebendazole.
• Public-sector procurement substitution.
• New pediatric dosage forms.

How many patents cover albendazole formulations?

The number of potentially relevant patent families is less important than claim scope, legal status, jurisdiction, and commercial relevance. Albendazole has been the subject of formulation research involving solid dispersions, nanoparticles, cyclodextrin complexes, lipid systems, and oral liquids. Many such disclosures may be expired, abandoned, limited to specific jurisdictions, or difficult to enforce against a conventional generic.

A commercial freedom-to-operate review should separate:

1. Expired albendazole compound patents.
2. Active formulation patents.
3. Process patents.
4. Method-of-use patents.
5. Manufacturing know-how that is not publicly disclosed.
6. Patent families covering excipient combinations used in other drugs.

For a new product, the strongest protection is likely to come from a narrow formulation architecture tied to measurable performance, not from broad ownership of albendazole itself.

Which companies are challenging or competing with albendazole?

The competitive field includes generic manufacturers, branded manufacturers, nonprofit suppliers, and public-health procurement organizations. The reference product has historically been associated with GlaxoSmithKline, while generic albendazole products are supplied by multiple manufacturers across the United States, India, China, Latin America, and other markets.

Mebendazole is the closest pharmaceutical comparator for intestinal helminth treatment. Ivermectin, praziquantel, pyrantel, and diethylcarbamazine compete in overlapping parasitic-disease programs, depending on the pathogen and treatment setting.

Competitor	Main overlap	Albendazole vulnerability
Mebendazole	Intestinal nematodes	Price and public-health substitution
Ivermectin	Selected helminth and ectoparasitic indications	Different spectrum and dosing profile
Praziquantel	Cestode and trematode infections	Stronger position for schistosomiasis and some tapeworms
Pyrantel	Intestinal nematodes	Low-cost single-dose competition
Diethylcarbamazine	Filariasis	Disease-specific substitution

What commercial opportunities exist for albendazole excipient innovation?

Pediatric public-health products

A dispersible, palatable, heat-stable product could compete for deworming programs supported by governments, UNICEF, WHO-linked initiatives, and nongovernmental organizations. Price remains decisive, but improved administration and reduced need for tablet crushing can create procurement value.

Systemic infection formulations

A formulation that improves systemic exposure or reduces food dependence may support premium positioning in neurocysticercosis and hydatid disease. This market is smaller than mass deworming but has greater tolerance for formulation complexity.

Hospital and specialty oral liquids

Patients with neurocysticercosis may require prolonged treatment. An oral liquid or dispersible formulation can address swallowing difficulties, enteral feeding, and dose adjustment. Stability after opening, microbial control, and dose uniformity are critical.

Veterinary products

Albendazole is widely used in veterinary medicine. Opportunities include species-specific suspensions, boluses, drenches, and feed-compatible formulations. Veterinary products may have shorter development cycles than human products, but price competition and residue requirements are significant.

Fixed-dose and combination products

Combination products could improve treatment coverage in settings with mixed parasitic infections. Regulatory and clinical complexity is higher because each active ingredient must demonstrate compatibility, stability, and an acceptable benefit-risk profile.

What patent litigation and Paragraph IV risks affect albendazole?

Albendazole is not primarily a current Paragraph IV litigation market. The original product is exposed to established generic competition, and the more relevant litigation risk would arise from a newly patented formulation or dosage form.

A formulation developer should expect potential disputes over:

• Obviousness of combining albendazole with known solubilizers.
• Anticipation by prior solid-dispersion or nanoparticle disclosures.
• Inherency of dissolution or bioavailability results.
• Patent eligibility and written description.
• Enablement across broad excipient ranges.
• Infringement by generic manufacturing processes.

Settlement agreements are less likely to create a meaningful market barrier for conventional albendazole products than for high-value, patent-protected medicines. Any formulation-specific settlement would need to be evaluated against the remaining patent term and the narrowness of the protected product.

How strong is the albendazole patent estate?

The legacy albendazole estate is commercially weak compared with protected branded drugs. The molecule is old, generics are available, and routine immediate-release tablets have limited differentiation.

A new formulation estate could be moderate to strong if it combines:

• A defined and reproducible formulation structure.
• Demonstrated dissolution or exposure improvement.
• A non-obvious excipient interaction.
• Long-term stability data.
• Commercially meaningful pediatric or systemic benefits.
• Claims that cover manufacturing as well as composition.

The estate is weak if it relies on an open-ended list of conventional excipients, lacks comparative data, or claims only an expected result such as "improved solubility."

What generic launch scenarios exist?

The most probable launch scenarios are:

1. A low-cost conventional 200 mg tablet.
2. A chewable or dispersible pediatric tablet.
3. A reconstitutable oral suspension.
4. A specialty formulation with improved systemic exposure.
5. A veterinary suspension or bolus.
6. A combination product for public-health use.

The conventional tablet has the lowest technical and regulatory risk but also the lowest differentiation. The pediatric dispersible product offers the best balance of technical feasibility and commercial need. A nanosuspension or solid dispersion offers greater intellectual-property potential but requires more demanding stability and bioequivalence work.

Key Takeaways

• Albendazole’s central formulation constraint is poor aqueous solubility and variable oral exposure.
• The strongest excipient opportunities are dispersible tablets, chewable products, pediatric suspensions, nanosuspensions, and amorphous solid dispersions.
• Conventional excipients such as lactose, starch, povidone, sodium starch glycolate, and magnesium stearate support low-cost generic products but offer limited differentiation.
• Surfactants and polymeric carriers can improve dissolution but introduce taste, stability, precipitation, and regulatory risks.
• Albendazole has no biosimilar risk because it is a small-molecule drug.
• Legacy compound exclusivity is no longer the main market barrier.
• New commercial protection would need to come from formulation, process, dosage-form, or method-of-use claims.
• Pediatric public-health products provide the clearest volume opportunity.
• Improved systemic formulations may support higher margins in neurocysticercosis and hydatid disease.
• The most defensible patents will link defined excipient systems to measurable dissolution, stability, bioavailability, or administration benefits.

FAQs

Can albendazole be formulated as an oral suspension?

Yes. An oral suspension can address pediatric dosing and swallowing difficulties. The formulation must control sedimentation, redispersibility, microbial growth, dose uniformity, taste, and chemical stability.

Which solubilizers are most promising for albendazole?

Poloxamers, polysorbates, sodium lauryl sulfate, lipid vehicles, cyclodextrins, and polymeric solid-dispersion carriers are potential options. The optimal choice depends on whether the product is a tablet, suspension, nanosuspension, or lipid-based system.

Does albendazole require a high-fat meal?

Food, particularly a high-fat meal, can increase systemic exposure to albendazole sulfoxide. Product labeling and clinical use should distinguish intestinal treatment from systemic infections, where exposure is more important (FDA, 2023).

Is albendazole suitable for an orally disintegrating tablet?

Yes, but taste masking is a major development requirement. Mannitol, crospovidone, microcrystalline cellulose, flavors, sweeteners, and coated granules can support an orally disintegrating or chewable design.

Can excipient selection create new patent protection for albendazole?

Yes, if the formulation includes a novel, non-obvious, and adequately supported excipient architecture or manufacturing process. A simple combination of known albendazole excipients is more vulnerable to obviousness and prior-art challenges.

References

1. Food and Drug Administration. (2023). Albenza (albendazole) tablets, prescribing information. U.S. Department of Health and Human Services.

2. Food and Drug Administration. (2023). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

3. World Health Organization. (2023). WHO guideline on control and elimination of human schistosomiasis and soil-transmitted helminthiasis. World Health Organization.

4. World Health Organization. (2022). WHO model list of essential medicines, 22nd list. World Health Organization.

5. U.S. National Library of Medicine. (2024). Albendazole: Drug information and clinical pharmacology. DailyMed.