Nifurtimox - Generic Drug Details

What are the generic sources for nifurtimox and what is the scope of patent protection?

Nifurtimox is the generic ingredient in one branded drug marketed by Bayer Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for nifurtimox

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	22
What excipients (inactive ingredients) are in nifurtimox?	nifurtimox excipients list
DailyMed Link:	nifurtimox at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for nifurtimox

Constraining patent/regulatory exclusivity:

INDICATED IN PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 2.5 KG) FOR THE TREATMENT OF CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS) CAUSED BY TRYPANOSOMA CRUZI

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for nifurtimox

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

Sponsor	Phase
Juan D. Maya	Phase 2
Drugs for Neglected Diseases initiative	Phase 3
Laboratorio Elea Phoenix S.A.	Phase 3

See all nifurtimox clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for nifurtimox

P01CC	Nitrofuran derivatives
P01C	AGENTS AGAINST LEISHMANIASIS AND TRYPANOSOMIASIS
P01	ANTIPROTOZOALS
P	Antiparasitic products, insecticides and repellents

US Patents and Regulatory Information for nifurtimox

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bayer Healthcare	LAMPIT	nifurtimox	TABLET;ORAL	213464-002	Aug 6, 2020		RX	Yes	Yes
Bayer Healthcare	LAMPIT	nifurtimox	TABLET;ORAL	213464-001	Aug 6, 2020		RX	Yes	No

Nifurtimox Market Dynamics, Financial Trajectory, and Patent Outlook

Last updated: September 8, 2026

Nifurtimox is a low-volume, specialty anti-infective with strategic value disproportionate to its reported sales. The U.S. product, Lampit, gained FDA approval in 2020 for pediatric Chagas disease, creating a regulated commercial market for an old active ingredient. Revenue remains constrained by limited diagnosis, public-sector procurement, endemic-country affordability, and the absence of a broad adult U.S. indication. The principal commercial protection is orphan-drug exclusivity through August 2027, supplemented by a later-expiring U.S. use patent family associated with Bayer.

Standalone sales are not disclosed in Bayer’s public financial reporting. The financial trajectory is therefore best assessed through regulatory milestones, treatment volume, pricing structure, public procurement, and access expansion rather than reported product revenue.

What is nifurtimox used for and how large is the market?

Nifurtimox is a nitrofuran derivative used to treat Chagas disease, a parasitic infection caused by Trypanosoma cruzi. The disease is endemic in Latin America but has spread through migration to the United States, Europe, Japan and other regions.

The World Health Organization estimates that approximately 6 million to 7 million people are infected globally, with most cases undiagnosed. About 20% to 30% of infected patients may develop cardiac or gastrointestinal complications over time.[1]

The addressable treatment market is much smaller than the infected population because:

• Most infected individuals are not diagnosed.
• Treatment is most effective before advanced cardiac or gastrointestinal disease.
• Health systems in endemic countries rely heavily on public procurement and donor programs.
• Adult treatment courses require prolonged adherence.
• Benznidazole is a direct therapeutic competitor.
• Chagas disease receives limited commercial and clinical-development funding.

Nifurtimox has its strongest commercial position in pediatric Chagas disease, treatment-intolerant patients, and settings where national programs use it as an alternative to benznidazole.

What is the FDA status of Lampit?

Lampit was approved by the FDA on August 7, 2020, for pediatric patients weighing at least 2.5 kilograms and younger than 18 years with Chagas disease.[2]

The approved product is available as:

Product	Strength	Administration
Lampit	30 mg	Oral tablet
Lampit	120 mg	Oral tablet

The FDA label uses weight-based dosing administered three times daily for 60 days. Tablets are scored and may be dispersed in water for patients unable to swallow them whole.[2]

The approval is important commercially because it transformed nifurtimox from a largely donor-supplied or nationally procured medicine into an FDA-regulated branded product with an identifiable U.S. reimbursement and specialty-distribution pathway.

Lampit received orphan-drug designation for Chagas disease. The approval also addressed a neglected tropical disease for which the FDA has limited treatment options. Nifurtimox is not a biologic, so biosimilar approval pathways do not apply.

When does nifurtimox lose regulatory exclusivity?

Lampit’s seven-year U.S. orphan-drug exclusivity period runs from the FDA approval date and is expected to expire on August 7, 2027.[2,3]

The principal U.S. regulatory milestones are:

Milestone	Date	Commercial effect
FDA approval of Lampit	August 7, 2020	Established U.S. branded market
Orphan exclusivity begins	August 7, 2020	Blocks approval of the same drug for the same indication, subject to statutory exceptions
Orphan exclusivity expected to end	August 7, 2027	Opens a potential regulatory pathway for competing applications
Later patent protection	Expected into the mid-2030s for relevant use claims	May delay commercial generic competition even after orphan exclusivity

Orphan exclusivity is not the same as patent protection. It prevents FDA approval of the same drug for the same orphan indication during the exclusivity period, but it does not prevent all forms of competition. A competitor could potentially pursue a different indication, challenge orphan exclusivity, or rely on a different regulatory strategy.

Nifurtimox does not qualify for five-year new chemical entity exclusivity because the active ingredient was known and used outside the United States before Lampit’s approval. The product may have received other FDA protections associated with the supporting clinical data, but those protections are materially shorter than the relevant patent term.

What patents protect Lampit and nifurtimox?

The active ingredient itself is old and cannot support a conventional composition-of-matter patent with a long remaining term. Commercial protection instead depends on formulation, dosing, treatment-method and product-specific patent claims.

A U.S. patent commonly associated with the Lampit estate is:

Patent	Applicant or assignee	Subject matter	Reported expiration
U.S. Patent No. 10,583,110	Bayer-related entity	Nifurtimox treatment methods, including Chagas-disease use	December 2034, before any applicable adjustment

The patent’s commercial relevance depends on the claims listed for the FDA product, the Orange Book patent-use code, claim scope, terminal disclaimers and any patent-term adjustment. Patent expiry can differ from the nominal term because of prosecution delays and statutory adjustments.

The key protection layers are:

Method-of-use protection

Use patents can cover administration of nifurtimox for Chagas disease, patient populations, treatment duration or weight-based dosing. These claims are more commercially relevant than the old active-ingredient chemistry because they target the approved therapeutic use.

Formulation protection

Lampit uses orally administered scored tablets designed for pediatric weight-based dosing. Formulation and dispersibility claims can create barriers for a competing product, particularly where the reference product must be reproduced in pediatric-friendly dosage forms.

Manufacturing and supply protection

Nifurtimox manufacturing does not appear to create the same technical barrier as complex biologics, antibody conjugates or sterile injectables. The main manufacturing risks are active-pharmaceutical-ingredient qualification, quality consistency, pediatric tablet production and regulatory documentation. Supply reliability may matter more than chemical complexity because the market is small and manufacturers have limited incentive to maintain redundant capacity.

What is the Orange Book status of Lampit?

Lampit is listed in FDA product databases as an approved prescription drug under NDA 214743. The relevant Orange Book analysis is product- and patent-specific because a listed patent may cover only a labeled method of use rather than the tablet itself.[3]

For a generic applicant, the main possible pathways are:

1. A Paragraph IV certification challenging listed patents.
2. A Section VIII statement seeking approval for an unpatented indication.
3. A 505(b)(2) application with different clinical or labeling claims.
4. A full or abbreviated application filed after applicable regulatory exclusivity expires.

No widely reported U.S. Paragraph IV litigation or generic launch has materially disrupted Lampit’s market through 2024. The absence of a reported challenge is consistent with the small market, limited commercial upside, orphan exclusivity and the difficulty of recovering litigation costs from a narrow indication.

Which companies compete with nifurtimox?

Benznidazole is nifurtimox’s principal pharmacological competitor.

Attribute	Nifurtimox	Benznidazole
U.S. branded product	Lampit	Benznidazole tablets
U.S. approval	2020	2017
U.S. pediatric positioning	Patients under 18 years	Pediatric patients, including young children
Manufacturer or commercial sponsor	Bayer-related Lampit commercial structure	Commercialized in the U.S. through specialty-pharmaceutical channels
Treatment duration	Commonly 60 days	Commonly 60 days
Key commercial advantage	FDA-approved pediatric liquid-dispersion tablet design and established nifurtimox supply	Earlier U.S. approval and broad clinical familiarity
Main limitation	Narrow diagnosed population and high access friction	Adverse effects and limited disease awareness

The two drugs are not perfect substitutes in clinical practice. Choice depends on patient age, weight, tolerance, availability, physician preference, national treatment guidelines and procurement contracts.

Fexinidazole is another relevant competitor in the broader Chagas pipeline. It has been authorized in Europe for adult chronic indeterminate or determinate Chagas disease, but it has not created the same FDA commercial position as Lampit.[4]

How strong is the nifurtimox patent estate?

The patent estate is moderate rather than dominant.

Its strengths are:

• A U.S. FDA-approved product with orphan exclusivity.
• A potential method-of-use patent term extending into the 2030s.
• A pediatric formulation that creates practical development requirements for generic competitors.
• Limited immediate commercial incentive for challengers because the treated population is small.

Its weaknesses are:

• No meaningful new-chemical-entity protection.
• An old active ingredient with established prior art.
• Dependence on use and formulation claims, which are narrower than composition-of-matter claims.
• Potentially limited enforceability against a product designed around different dosing, labeling or formulation claims.
• A market in which public-health procurement can reduce branded pricing power.

Patent strength is therefore more defensible for the labeled pediatric use than for the underlying molecule. The market is protected by the combined effect of orphan exclusivity, patents, regulatory complexity and low expected generic returns, not by a single high-value composition patent.

What generic entry risks exist for nifurtimox?

The highest-risk period begins after orphan exclusivity expires in August 2027. Generic entry would still depend on the patent position and the economics of the market.

Near-term risk through 2027

Near-term generic risk is low. A competing product would face orphan exclusivity, possible listed patents, pediatric dosage-form requirements and a small commercial market.

2027 to patent expiry

Risk increases after orphan exclusivity ends. A challenger could file a Paragraph IV certification, pursue a 505(b)(2) route, or target an indication outside the orphan-protected use. Litigation would depend on the patents listed for Lampit and the exact proposed label.

After the mid-2030s

Risk becomes substantially higher if the principal U.S. method patents expire without additional patents or regulatory extensions. At that point, generic nifurtimox tablets could compete on price, although public procurement, limited diagnosis and API supply would still constrain market expansion.

A generic launch could be commercially viable if it secures national-program contracts, supplies nonprofit treatment programs or sells into markets where Lampit pricing is unaffordable. U.S. commercial economics alone may not justify development by multiple generic manufacturers.

What is the financial trajectory for nifurtimox?

Public companies do not report Lampit revenue as a separate line item. Bayer reports results by business segment rather than by individual orphan product, preventing a reliable product-level revenue series.[5]

The commercial trajectory can be divided into four phases.

Pre-2020: donor and public-health supply

Before U.S. approval, nifurtimox was primarily supplied through national programs, international procurement and donation arrangements. Revenue was driven by volume commitments and public-health access rather than conventional branded pricing.

2020 to 2022: regulatory-market creation

FDA approval created a U.S. prescription market and enabled specialty distribution. Initial sales were likely constrained by physician awareness, diagnostic rates, payer restrictions and the impact of the COVID-19 pandemic on elective diagnosis and treatment.

2023 to 2026: access expansion

The commercial opportunity depends on improving diagnosis among immigrant and Latin American populations in the United States, integrating Chagas screening into blood-bank and maternal-health programs, and maintaining supply in endemic countries. Growth can occur without large price increases if treatment identification improves.

2027 onward: exclusivity transition

The August 2027 orphan-exclusivity expiry creates a strategic decision point. The product may retain value through brand loyalty, supply reliability, pediatric formulation convenience and public contracts. However, a patent challenge or authorized generic could compress U.S. pricing before substantial volume growth occurs.

The most important financial variables are:

Variable	Effect on revenue
Chagas diagnosis rate	Determines treated-patient volume
Pediatric case identification	Directly supports Lampit’s FDA label
U.S. reimbursement	Determines access and net price
Public procurement	Supports volume but limits pricing
Donation programs	Expands treatment but may not generate commercial revenue
Generic timing	Determines post-2027 price pressure
API availability	Affects continuity and contract performance
Competitive use of benznidazole	Limits market share

The base-case commercial outlook is a durable but niche product, not a high-growth specialty pharmaceutical. Revenue may rise as diagnosis improves, but the untreated population is difficult to reach and public-health channels place structural limits on price expansion.

What licensing and commercial agreements affect nifurtimox?

Nifurtimox has historically been associated with Bayer’s supply and access activities, including provision for Chagas disease programs and collaboration with international health organizations. Public-sector and nonprofit arrangements are more important than conventional royalty-bearing licensing in determining global access.

The commercial structure has included a distinction between:

• Branded U.S. commercialization through the Lampit product.
• Public-health supply in endemic countries.
• Donation or access programs coordinated with international organizations.
• National tenders and institutional procurement.

No publicly disclosed transaction has established a large independent valuation for Lampit or a major third-party royalty stream. The absence of a reported standalone licensing valuation reinforces the view that nifurtimox is strategically important as an access product but not a material disclosed revenue driver for Bayer.

What patent litigation affects nifurtimox?

No major public U.S. patent litigation involving Lampit had materially affected market access through 2024. The litigation risk is concentrated in the period following orphan-exclusivity expiry.

Potential disputes would likely concern:

• Validity of method-of-use claims.
• Infringement by pediatric dosing labels.
• Formulation or tablet-dispersion claims.
• Patent-listing accuracy in the Orange Book.
• Indication carve-outs by an abbreviated applicant.
• Whether a competing label induces infringement.

Because the market is narrow, a settlement could be more attractive than prolonged litigation. A potential agreement could include a delayed generic entry date, a licensed generic, a supply arrangement or an authorized-generic structure.

Key Takeaways

• Nifurtimox is an FDA-approved pediatric Chagas treatment marketed in the United States as Lampit.
• FDA approval occurred on August 7, 2020; orphan exclusivity is expected to run through August 7, 2027.
• The active ingredient is old, so commercial protection depends on orphan exclusivity, method-of-use patents, formulation claims and supply capabilities.
• U.S. Patent No. 10,583,110 is a key patent associated with the nifurtimox Chagas-disease use estate, with a reported term extending into December 2034 before applicable adjustments.
• Benznidazole is the principal direct competitor.
• No material U.S. Paragraph IV challenge or generic disruption had been publicly reported through 2024.
• Bayer does not separately disclose Lampit revenue, preventing a verified product-level sales history.
• The market is strategically important for neglected-disease access but remains commercially limited by underdiagnosis, public procurement and low treatment volumes.
• Generic risk rises after August 2027 and becomes more substantial after relevant method patents expire.
• Long-term value depends more on diagnosis and procurement expansion than on premium pricing.

FAQs

Is nifurtimox a high-revenue pharmaceutical product?

No. Nifurtimox is a niche anti-infective with limited reported commercial scale. Bayer does not disclose Lampit revenue separately, and the market is constrained by low Chagas-disease diagnosis rates.

Can a generic manufacturer launch nifurtimox before 2027?

A competing FDA-approved product for the same orphan indication would face Lampit’s orphan exclusivity through August 2027. Patent claims and the proposed label could create additional barriers.

Is nifurtimox covered by a composition-of-matter patent?

The active ingredient is old and does not have the type of long-duration new-chemical-entity protection available to recently discovered drugs. The relevant commercial estate centers on treatment methods, formulation and product-specific claims.

Does nifurtimox have biosimilar competition?

No. Nifurtimox is a small-molecule drug, not a biologic. Any future competitor would use a generic, 505(b)(2) or other small-molecule pathway rather than a biosimilar pathway.

Which drug competes most directly with Lampit?

Benznidazole is the closest direct competitor in Chagas disease treatment. Clinical choice depends on patient age, tolerability, local availability, physician preference and procurement arrangements.

References

1. World Health Organization. (2023). Chagas disease (American trypanosomiasis). https://www.who.int/news-room/fact-sheets/detail/chagas-disease-(american-trypanosomiasis)

2. U.S. Food and Drug Administration. (2020). Lampit (nifurtimox) prescribing information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/214743s000lbl.pdf

3. U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/

4. European Medicines Agency. (2018). Fexinidazole Winthrop: EPAR product information. https://www.ema.europa.eu/

5. Bayer AG. (2024). Annual report 2023. https://www.bayer.com/en/investors/annual-reports