NICLOCIDE Drug Patent Profile

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

Niclocide is a drug marketed by Bayer Pharms and is included in one NDA.

The generic ingredient in NICLOCIDE is niclosamide. There is one drug master file entry for this compound. Additional details are available on the niclosamide profile page.

Summary for NICLOCIDE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	83
Patent Applications:	4,067
DailyMed Link:	NICLOCIDE at DailyMed

US Patents and Regulatory Information for NICLOCIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Pharms	NICLOCIDE	niclosamide	TABLET, CHEWABLE;ORAL	018669-001	May 14, 1982		DISCN	No	No

Niclocide Market Dynamics, Patent Status, and Financial Trajectory

Last updated: August 24, 2026

Niclocide is a legacy brand of niclosamide, a 500 mg oral anthelmintic used primarily for tapeworm infections. Its commercial trajectory is defined by mature-product economics: limited disease prevalence, low treatment frequency, extensive generic substitution, minimal differentiation, and no meaningful remaining branded exclusivity in the United States. Public filings do not disclose standalone Niclocide revenue, and the product has no identifiable basis for material near-term pharmaceutical growth.

What is Niclocide and what is it used for?

Niclocide is the former U.S. brand associated with niclosamide chewable tablets. Niclosamide is a salicylanilide anthelmintic indicated for infections caused by adult tapeworms, including Taenia saginata, Taenia solium, Diphyllobothrium latum, and Hymenolepis nana.[1]

Attribute	Niclocide
Active ingredient	Niclosamide
Dosage form	Oral chewable tablet
Common strength	500 mg
Therapeutic class	Anthelmintic
Primary use	Tapeworm infections
U.S. commercial status	Legacy/discontinued branded product; current availability depends on jurisdiction and supplier
Prescription status	Prescription product in the United States
Biosimilar exposure	None
Generic exposure	High
Current patent-driven exclusivity	None of commercial significance

Niclosamide acts locally in the intestinal lumen and has limited systemic absorption. Its clinical value is concentrated in a narrow infectious-disease market rather than chronic or high-volume primary care.

When did Niclocide lose exclusivity?

Niclocide lost meaningful market exclusivity decades ago. The active ingredient was introduced long before the modern Hatch-Waxman exclusivity framework, and any original composition or product patents would have expired well before the current commercial period.

The commercial position is therefore determined by generic competition, regulatory status, manufacturing economics, and availability rather than by patent protection.

Niclocide exclusivity timeline

Period	Commercial event	Market effect
Pre-1980s	Niclosamide established as an anthelmintic	Original product protection aged out
1980s-1990s	Branded prescription product competed with alternative suppliers	Limited market growth
2000s	Mature generic and international supply base developed	Pricing pressure increased
2010s	U.S. branded relevance declined	Product became a low-volume legacy medicine
2020-2022	Niclosamide evaluated for COVID-19 repurposing	Temporary research-driven attention without durable demand
Current period	No meaningful branded exclusivity	Market access depends on approved suppliers and procurement

The FDA’s Orange Book framework provides no basis for treating Niclocide as a protected branded asset. Patent exclusivity should not be confused with regulatory availability. A product can remain listed in historical records while having no active commercial franchise.[2]

What patents protect Niclocide?

No commercially material active U.S. patent estate protects Niclocide or ordinary niclosamide tablets.

Composition-of-matter patents

Niclosamide is an old small molecule. Any original composition-of-matter protection expired many years ago. Patent risk from the active ingredient is therefore negligible for conventional oral anthelmintic use.

Formulation patents

A conventional 500 mg chewable tablet does not have an identifiable high-value formulation barrier. Potential patents covering nanoparticles, targeted delivery, salts, solid dispersions, or specialized formulations would protect only the claimed formulation and not ordinary niclosamide tablets.

Such patents could matter in a new indication, particularly oncology or antiviral development, but they would not restore exclusivity to the legacy Niclocide product without a commercially relevant approved product and enforceable claims.

Method-of-use patents

Method-of-use rights could affect a new indication. Niclosamide has been studied in areas including:

• Viral infections, including SARS-CoV-2
• Oncology
• Metabolic disease
• Parasitic disease outside the original tapeworm indications

These investigations do not create exclusivity for Niclocide’s established anthelmintic use. A method patent would need valid claims covering a specific indication, dosing regimen, patient population, or treatment method. It would also require regulatory and commercial adoption.

What is the Orange Book status of Niclocide?

Niclocide has no meaningful Orange Book-based commercial protection.

The Orange Book can identify approved drug products, therapeutic-equivalence information, patents submitted by NDA holders, and exclusivity periods. For a legacy niclosamide product, the relevant commercial facts are:

1. The original product is old.
2. Any original patents have expired.
3. Generic substitution is the principal competitive mechanism.
4. There is no current branded exclusivity comparable to a new chemical entity, pediatric extension, or active patent-protected formulation.
5. Product discontinuation or absence from current distribution can limit practical access even when the underlying active ingredient remains approved or available elsewhere.

The FDA’s product databases should be used to distinguish between discontinued marketing, withdrawn approval, temporary supply shortages, and continued availability from a different manufacturer.[2,3]

How many patents cover Niclocide?

The number of historical patent documents associated with niclosamide is less important than the absence of a live, commercially relevant patent barrier around the legacy product.

Patent category	Current commercial relevance
Original niclosamide composition	Expired
Conventional oral tablet	No meaningful active exclusivity
Chewable tablet technology	Low, absent a narrow enforceable claim
New antiviral formulations	Potentially relevant only to the claimed product and use
Oncology formulations	Potentially relevant to development-stage products
Manufacturing processes	May affect supplier economics but rarely blocks generic entry
Method-of-use claims	Relevant only to the protected indication and regimen

Patent counting can overstate strength because a portfolio may contain expired, abandoned, narrow, or development-stage filings. For Niclocide, the commercially relevant patent count is effectively zero for the mature tapeworm product.

Which companies are challenging Niclocide?

The competitive threat comes from generic and international niclosamide suppliers rather than from a named litigation campaign.

Generic competition

Niclosamide is available in multiple markets under different manufacturers and trade names. Depending on country, competition may include:

• Generic tablet manufacturers
• Contract manufacturers supplying public-health tenders
• Regional pharmaceutical companies
• Hospital and antiparasitic procurement suppliers
• Compounding or extemporaneous supply channels where permitted

The U.S. market is structurally less attractive than high-volume generic categories because tapeworm treatment is episodic and demand is small. A supplier may maintain authorization or manufacturing capability without actively promoting the product.

Paragraph IV challenges

A meaningful current Paragraph IV campaign against Niclocide is unlikely because the product has no evident active branded patent barrier capable of supporting a substantial launch opportunity. Paragraph IV litigation typically requires a listed patent with enough remaining term and market value to justify legal expense.

For Niclocide, generic entry is more likely to occur through ordinary abbreviated new drug application pathways, market re-entry by an existing supplier, or international sourcing than through high-profile patent litigation.

What formulation patents protect niclosamide products?

New formulation research has focused on improving solubility, absorption, tissue distribution, and exposure. These technologies could create more defensible products than conventional Niclocide tablets, but they would represent new development programs rather than extensions of the legacy brand.

Potentially differentiated formulation areas

Formulation approach	Commercial purpose	Patent strength potential
Nanoparticles	Improve dissolution or tissue exposure	Moderate to high if claims are narrow and reproducible
Lipid-based systems	Improve oral absorption	Moderate
Solid dispersions	Increase solubility	Moderate, with formulation-design-around risk
Injectable formulations	Enable systemic exposure	Potentially high, but development risk is substantial
Targeted delivery	Direct drug to tumors or infected tissue	Potentially high if clinical benefit is shown
Combination products	Pair niclosamide with another active ingredient	Dependent on clinical and claim scope

The main barrier is clinical validation rather than basic patentability. A reformulated product would need to show a meaningful therapeutic advantage over low-cost generic niclosamide or existing standard treatment.

What is the FDA regulatory status of Niclocide?

The FDA-approved legacy use of niclosamide is anthelmintic treatment. Niclosamide has not become an FDA-approved COVID-19, oncology, or metabolic-disease product based solely on laboratory studies or clinical investigation.

The regulatory profile has four practical implications:

• The established tapeworm indication has a known clinical and safety history.
• New indications require separate evidence and regulatory review.
• Repurposing interest does not equal approval.
• The old drug’s safety record does not eliminate the need to establish efficacy, dosing, exposure, and benefit-risk for a new disease.

During the COVID-19 pandemic, niclosamide attracted substantial laboratory and early-stage clinical interest. Clinical studies did not establish a commercially transformative role for standard oral niclosamide in COVID-19. The NICCO program evaluated oral niclosamide in hospitalized patients and did not produce the type of clinical result required to support a major antiviral franchise.[4]

What is the financial trajectory for Niclocide?

Niclocide’s financial trajectory is flat to declining as a branded asset, with no publicly reported standalone revenue base.

Revenue drivers

Driver	Effect on Niclocide
Tapeworm prevalence	Supports low, episodic demand
Treatment duration	Limits repeat prescription volume
Generic substitution	Reduces branded pricing power
Product discontinuation	Can reduce visibility and access
International demand	Provides residual volume in endemic markets
Public-health procurement	Creates tender-driven sales rather than stable branded revenue
COVID-19 repurposing	Created temporary interest without durable sales
New formulations	Could create value only through successful redevelopment

Niclocide does not have the characteristics of a high-value specialty or chronic-care medicine. Treatment is generally short-course, the target population is limited, and prescribers have little reason to pay a premium for an old branded product when equivalent niclosamide supply is available.

Revenue exposure for manufacturers

For any company holding or supplying Niclocide, revenue exposure is likely to be:

• Low in absolute terms
• Sensitive to product availability
• Concentrated among a small number of distributors or tenders
• Vulnerable to generic price competition
• Insufficient to affect the financial profile of a large diversified pharmaceutical company

No reliable public source establishes material annual Niclocide revenue, product-level operating profit, or a separately reported forecast. Treating Niclocide as a major revenue contributor would overstate its commercial importance.

How strong is the Niclocide patent estate?

The patent estate is weak for the legacy product and potentially meaningful only for new formulations or new indications.

Dimension	Assessment
Active ingredient protection	Very weak; expired
Conventional tablet protection	Weak
Brand differentiation	Weak
Regulatory exclusivity	None of commercial significance
Generic entry risk	High
Manufacturing barriers	Low to moderate
New-indication patent potential	Moderate, claim-dependent
Litigation leverage	Low
Licensing value	Low for legacy product; potentially higher for validated reformulation

Manufacturing complexity is limited for conventional niclosamide tablets. The more relevant supply risks involve active pharmaceutical ingredient qualification, quality control, regulatory filing maintenance, and small-volume manufacturing economics.

What patent litigation affects Niclocide?

No major current U.S. patent litigation is associated with the legacy Niclocide product in the commercial record generally relied upon for branded pharmaceutical analysis.

A litigation strategy would be difficult to justify without:

• An active listed patent
• A commercially valuable branded product
• A credible infringement theory
• A sufficiently large market
• A launch that creates recoverable damages

Those conditions do not characterize conventional Niclocide.

Could a generic launch materially affect the market?

A new generic supplier could gain share quickly if it secures regulatory approval and reliable distribution. The financial upside would still be limited by market size.

Likely generic launch scenarios

Scenario	Probability profile	Commercial result
One supplier re-enters a supply-constrained market	Plausible	Temporary price improvement
Multiple suppliers compete	Likely over time	Rapid price erosion
Branded Niclocide relaunch	Low commercial rationale	Limited premium potential
New formulation launch	Development-dependent	Higher value only with proven benefit
New indication approval	Low near-term visibility	Could create a separate market
Public-health tender expansion	Region-specific	Volume increase with margin pressure

The best near-term generic opportunity would arise from a supply gap, not from patent exclusivity. Such opportunities are usually temporary and depend on procurement contracts, manufacturing reliability, and regulatory status.

How does Niclocide compare with competing antiparasitic drugs?

Niclosamide competes with other anthelmintics based on parasite species, treatment guidelines, safety, availability, and cost.

Drug	Main use profile	Competitive position
Niclosamide	Intestinal tapeworms	Established but narrow
Praziquantel	Broad cestode and trematode use	Stronger broad-spectrum position
Albendazole	Several helminth infections	Larger general antiparasitic market
Mebendazole	Common intestinal nematodes	Different principal use
Ivermectin	Selected nematode and ectoparasite indications	Broader recognition and volume

Praziquantel and albendazole generally have stronger market relevance because of broader indications and larger public-health use cases. Niclosamide retains clinical value where its specific tapeworm activity and local intestinal mechanism are appropriate, but it lacks the commercial breadth of those competitors.

What licensing deals could create value for niclosamide?

The legacy Niclocide product has limited licensing value. A licensing transaction would be more plausible around:

• A proprietary formulation
• A new delivery system
• A validated oncology use
• A clinically supported antiviral indication
• A regional commercialization right
• A manufacturing or supply agreement

A license based solely on conventional niclosamide tablets would face weak pricing power and high generic competition. Any meaningful transaction would need to rely on differentiated clinical data, a defensible patent position, regulatory progress, or access to a supply-constrained market.

Key Takeaways

• Niclocide is a legacy niclosamide brand for tapeworm infections.
• Its original patent and exclusivity position expired long ago.
• Generic entry risk is high, while Paragraph IV litigation risk is low.
• The conventional 500 mg chewable tablet has little defensible product differentiation.
• Public filings do not disclose material standalone Niclocide revenue.
• The commercial market is small, episodic, and price-sensitive.
• COVID-19 repurposing interest did not produce a durable commercial franchise.
• New formulations or indications could have value, but that would be a separate product strategy.
• Praziquantel and albendazole have broader commercial relevance in antiparasitic therapy.
• Niclocide has limited licensing, litigation, or investment value as a legacy branded product.

FAQs

Is Niclocide still sold in the United States?

Niclocide is a legacy product, and U.S. availability is limited compared with its historical branded presence. Current access depends on FDA-listed status, approved suppliers, pharmacy sourcing, and any available generic equivalents.

Is niclosamide the same drug as Niclocide?

Yes. Niclocide is a brand associated with niclosamide, commonly supplied as a 500 mg chewable tablet for tapeworm treatment.

Does niclosamide have patent protection for cancer treatment?

Some new-use and formulation patents may cover investigational oncology applications, but those rights would not protect conventional Niclocide tablets or the established anthelmintic indication.

Can niclosamide be approved for COVID-19?

COVID-19 approval would require positive clinical evidence and FDA review for that indication. Laboratory activity and early-stage studies do not establish approval or commercial exclusivity.

Is Niclocide a worthwhile pharmaceutical investment?

As a legacy branded product, Niclocide has limited investment appeal because of low market size, generic competition, expired exclusivity, and absent product-level financial disclosure. Value would depend on a differentiated formulation, new indication, or supply-constrained market strategy.

References

1. U.S. Food and Drug Administration. (n.d.). Niclosamide prescribing information and product labeling. FDA.

2. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. FDA.

3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. FDA.

4. Chowdhury, M. M., et al. (2022). Single-dose oral niclosamide in adults hospitalised with COVID-19: The NICCO randomized clinical trial. The Lancet Infectious Diseases.