NITROFURAZONE Drug Patent Profile

When do Nitrofurazone patents expire, and when can generic versions of Nitrofurazone launch?

Nitrofurazone is a drug marketed by Ambix, Lannett, Perrigo New York, Sun Pharma Canada, and Wendt. and is included in seven NDAs.

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

Summary for NITROFURAZONE

US Patents:	0
Applicants:	5
NDAs:	7
Raw Ingredient (Bulk) Api Vendors:	108
Clinical Trials:	1
Patent Applications:	5,664
DailyMed Link:	NITROFURAZONE at DailyMed

Recent Clinical Trials for NITROFURAZONE

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

Sponsor	Phase
University of Louisville	Early Phase 1
James Graham Brown Cancer Center	Early Phase 1
Julio Ramirez	Early Phase 1

See all NITROFURAZONE clinical trials

Medical Subject Heading (MeSH) Categories for NITROFURAZONE

Anti-Infective Agents

US Patents and Regulatory Information for NITROFURAZONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ambix	NITROFURAZONE	nitrofurazone	OINTMENT;TOPICAL	086077-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wendt	NITROFURAZONE	nitrofurazone	SOLUTION;TOPICAL	087081-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Sun Pharma Canada	NITROFURAZONE	nitrofurazone	OINTMENT;TOPICAL	086156-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lannett	NITROFURAZONE	nitrofurazone	OINTMENT;TOPICAL	084393-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Perrigo New York	NITROFURAZONE	nitrofurazone	OINTMENT;TOPICAL	084968-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Perrigo New York	NITROFURAZONE	nitrofurazone	SOLUTION;TOPICAL	085130-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Wendt	NITROFURAZONE	nitrofurazone	OINTMENT;TOPICAL	086766-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Nitrof​​urazone Market Dynamics, Patent Status, FDA Regulation, and Financial Trajectory

Last updated: August 3, 2026

Nitrofurazone is a mature nitrofuran antibacterial with limited commercial growth potential. Its current market is concentrated in low-cost topical veterinary products, particularly ointments, soluble dressings, and wound-treatment preparations. Human use has largely receded because of safety concerns, limited clinical demand, and competition from newer topical anti-infectives. No meaningful modern patent barrier protects the active ingredient, and no significant Orange Book exclusivity or Paragraph IV litigation is publicly associated with nitrofurazone.

The financial profile is therefore typical of an off-patent, low-price pharmaceutical: fragmented supply, modest unit economics, limited investment in clinical development, and revenue exposure tied to veterinary wound care rather than innovative human medicine.

What is nitrofurazone and how is it used?

Nitrofurazone, also known as nitrofural, is a synthetic nitrofuran antibacterial identified by CAS Registry Number 59-87-0. It inhibits bacterial enzymes involved in carbohydrate metabolism and nucleic-acid processes. Its activity is primarily topical because systemic use is limited by toxicity and poor commercial positioning.

Current and historical uses include:

Use area	Typical dosage form	Market status
Veterinary wound treatment	0.2% ointment, soluble dressing	Established niche
Equine wound care	Ointment, dressing, topical preparation	Important specialty segment
Treatment of burns and skin wounds	Ointment or cream	Historically used; limited modern relevance
Prevention of infection in surgical wounds	Topical preparation	Limited and declining
Aquaculture or food-producing animals	Historical or unauthorized use in some markets	Regulatory risk and generally prohibited
Human antibacterial therapy	Topical products	Commercially marginal in the United States

U.S. veterinary labeling identifies nitrofurazone products for bacterial infections associated with wounds, ulcers, burns, and skin grafts in animals. Some labels cover horses, cattle, sheep, and swine, but use in food-producing animals is subject to strict residue restrictions and prohibitions under federal law [1].

Nitrofurazone is not a modern systemic antibiotic market. Its commercial relevance is tied to topical products sold through veterinary distributors, animal-health suppliers, pharmacies, and online channels.

What is the FDA regulatory status of nitrofurazone?

Nitrofurazone has a clearer regulatory position in veterinary medicine than in current human pharmaceutical markets.

Veterinary FDA status

The FDA lists nitrofurazone in the animal-drug regulations under 21 C.F.R. Part 524. Approved dosage forms include topical preparations used for wound management and infection prevention in animals [2]. Commercial products are generally marketed as prescription veterinary drugs or under veterinary-use labeling, depending on the specific product and jurisdiction.

The FDA prohibits the use of nitrofurans, including nitrofurazone, in food-producing animals under 21 C.F.R. § 530.41. This restriction reduces the addressable market for livestock and creates compliance risk for products marketed into cattle, swine, sheep, aquaculture, or other food-animal channels [3].

Human FDA status

Human nitrofurazone products have a substantially weaker commercial position. Historical human use included burns, skin grafts, wounds, and superficial bacterial infections. Products may remain available in certain countries or through limited channels, but the U.S. market has not developed into a meaningful branded or generic category.

The primary commercial constraints are:

• limited contemporary clinical demand;
• availability of alternative topical antibacterials;
• concern over hypersensitivity and toxicity;
• potential mutagenicity and carcinogenicity concerns based on animal data;
• lack of strategic investment by major pharmaceutical companies.

Nitrofurazone should not be treated as an active U.S. human-growth pharmaceutical franchise.

What patents protect nitrofurazone?

No material composition-of-matter patent protects nitrofurazone today. The compound was developed decades ago, placing any original patent protection far beyond the standard U.S. patent term.

Patent category	Current relevance
Composition of matter	Expired
Original synthesis	Expired or commercially irrelevant
Basic topical use	Expired or vulnerable to prior art
Veterinary formulations	Potentially historical, but no known meaningful blocking estate
Modern delivery systems	Possible narrow protection for specific products, but not for nitrofurazone as an active ingredient
Manufacturing process	Potentially enforceable if newly developed, but unlikely to block ordinary generic production

A modern applicant could theoretically pursue a patent covering a specific formulation, dosage form, container, combination, or manufacturing process. Such a patent would not recreate exclusivity for the active ingredient itself. Any enforceable rights would be narrow and product-specific.

Public patent databases do not indicate a significant, commercially blocking nitrofurazone patent estate held by a major pharmaceutical company. The practical market position is therefore determined by regulatory compliance, manufacturing economics, distribution, and product quality rather than patent exclusion.

What is the Orange Book status of nitrofurazone?

Nitrofurazone does not have a commercially important current Orange Book position in the United States.

The FDA Orange Book primarily covers approved human prescription drug products and related patent and exclusivity information. Nitrofurazone’s current U.S. commercial activity is principally veterinary and topical. Veterinary approvals are handled through the FDA Center for Veterinary Medicine and are not equivalent to an Orange Book-listed human NDA franchise [4].

The commercial implications are significant:

• no active human Orange Book patent listing appears to create a meaningful barrier;
• no modern five-year new chemical entity exclusivity is relevant;
• no significant three-year clinical-investigation exclusivity is associated with the current market;
• abbreviated new drug application competition is not the central commercial issue because the human market is small and mature;
• veterinary generic approval depends more on the applicable animal-drug pathway and bioequivalence or pharmaceutical-equivalence requirements.

When does nitrofurazone lose exclusivity?

Nitrofurazone lost meaningful exclusivity decades ago. The original active-ingredient protection and early product rights are not relevant to present-day market entry.

There is no commercially relevant future patent cliff comparable to those affecting high-revenue branded drugs. The market is already in the post-exclusivity phase. Generic and private-label manufacturers can compete if they satisfy applicable FDA, veterinary, manufacturing, labeling, and quality requirements.

The key distinction is between legal exclusivity and practical entry barriers:

Barrier	Estimated commercial effect
Active-ingredient patent	Minimal
Orange Book patent	Minimal or absent
Regulatory approval	Moderate
cGMP manufacturing	Moderate
Veterinary distribution	Moderate
Product liability and quality control	Moderate
Brand loyalty	Low to moderate in specialty veterinary channels
Pricing power	Low

How many patents cover nitrofurazone?

No meaningful number of active, broad patents appears to cover nitrofurazone itself. The original molecule is public-domain technology for patent purposes.

Patent searches can identify historical filings for:

• nitrofuran chemistry;
• nitrofurazone synthesis;
• topical formulations;
• combinations with other anti-infective agents;
• veterinary wound treatments;
• delivery vehicles and dressings.

Those records should not be interpreted as a current blocking estate. Historical patents may remain useful for documenting prior art, but they do not normally prevent production of a standard nitrofurazone ointment or soluble dressing.

A market participant should assess any specific product patent separately. A claim covering a proprietary dressing, polymer matrix, sustained-release system, or combination therapy could create limited protection even when the active ingredient is unpatented.

What formulations are protected by nitrofurazone patents?

The most commercially relevant dosage forms are 0.2% ointments and soluble dressings. These are technically simple products, which limits the opportunity for durable formulation exclusivity.

Potential formulation claims could cover:

• a particular ointment base;
• improved stability;
• reduced staining;
• controlled release;
• a wound dressing or gauze matrix;
• a combination with an anesthetic, antiseptic, or anti-inflammatory agent;
• packaging that improves sterility or shelf life.

Publicly visible commercial products do not indicate a major formulation franchise comparable to patented transdermal systems, long-acting injectables, or complex biologic delivery platforms. Standard nitrofurazone topical products are generally exposed to substitution by other generic formulations.

Which companies are challenging nitrofurazone exclusivity?

No major public Paragraph IV campaign is associated with nitrofurazone. The molecule is too old and commercially limited to support the litigation economics typical of high-value generic challenges.

Competition is more likely to arise from:

• veterinary generic manufacturers;
• contract manufacturers;
• private-label distributors;
• compounding pharmacies, where legally permitted;
• alternative wound-care suppliers;
• manufacturers of non-antibiotic dressings and antiseptics.

Product-level disputes may still occur over trademarks, labeling, quality, distribution rights, or manufacturing contracts. Those disputes are different from a patent challenge to the active ingredient.

What patent litigation affects nitrofurazone?

No significant current U.S. patent litigation involving nitrofurazone is publicly associated with a major branded pharmaceutical company. The absence of litigation is consistent with the drug’s low revenue base, expired core technology, and limited human-market demand.

The litigation risk profile is more operational than patent-driven:

1. regulatory action involving unauthorized use in food-producing animals;
2. manufacturing deviations or contamination;
3. labeling disputes;
4. trademark conflicts involving legacy product names;
5. product-liability claims involving hypersensitivity or treatment failure;
6. import or distribution restrictions.

A prospective entrant should not assume that the absence of patent litigation eliminates regulatory risk. Nitrofurazone’s food-animal restrictions can create greater commercial exposure than intellectual-property enforcement.

What generic entry risks exist for nitrofurazone?

Generic entry risk is high because the molecule is old, inexpensive, and technically straightforward. The primary limitations are market size and regulatory economics, not legal exclusivity.

Human generic entry

A new human topical product would face weak commercial prospects. Approval costs, pharmacovigilance requirements, and product-liability exposure could exceed the value of the addressable market. Existing alternatives include silver sulfadiazine, mupirocin, bacitracin combinations, povidone-iodine, chlorhexidine, and non-antibiotic wound dressings.

Veterinary generic entry

Veterinary entry is more commercially plausible, particularly for equine products. However, manufacturers must address:

• approved animal species and indications;
• prescription or over-the-counter classification;
• residue restrictions;
• food-animal prohibitions;
• stability and microbial quality;
• packaging for barn and clinic use;
• channel access through veterinarians and animal-health distributors.

The practical launch model is usually a low-cost generic, private-label, or contract-manufactured product rather than a heavily promoted branded medicine.

How strong is the nitrofurazone patent estate?

The patent estate is weak from an exclusivity perspective.

Factor	Assessment
Composition-of-matter protection	None of practical current value
Remaining patent term	No material broad term identified
Formulation protection	Potentially narrow and product-specific
Method-of-use protection	Historically relevant, but not commercially blocking
Patent litigation exposure	Low
Freedom-to-operate for standard topical product	Generally favorable, subject to product-specific review
Regulatory complexity	Moderate
Commercial differentiation	Low

The strongest barriers are likely to be manufacturing consistency, regulatory documentation, veterinary distribution, and customer trust. A company with an established animal-health channel has a stronger competitive position than a company relying solely on patent ownership.

How does nitrofurazone compare with competing wound-care products?

Nitrofurazone competes in a crowded and declining topical anti-infective segment.

Product class	Relative position versus nitrofurazone
Mupirocin	Stronger human-market relevance and physician familiarity
Silver sulfadiazine	Established burn-care use and institutional presence
Povidone-iodine	Broad antiseptic use and lower regulatory complexity
Chlorhexidine	Strong veterinary and human antiseptic demand
Bacitracin combinations	Broad consumer recognition in some markets
Modern antimicrobial dressings	Higher technical differentiation and pricing
Plain wound dressings	Avoid antibiotic-resistance concerns and may replace topical antibiotics

Nitrofurazone retains utility where a low-cost topical antibacterial is accepted, particularly in veterinary wound management. It has limited ability to command premium pricing because substitutes are numerous and customers can switch with minimal technical friction.

What is the financial trajectory for nitrofurazone?

No reliable public source reports standalone global revenue, product-level profit, or market share for nitrofurazone. Products are sold by multiple manufacturers, and revenue is often embedded in broader veterinary, generic, or wound-care portfolios.

The likely financial trajectory is:

Period	Financial profile
Historical human-market phase	Broader use but declining clinical relevance
Mature generic phase	Low prices, fragmented supply, limited promotional spending
Current veterinary phase	Stable niche demand, led by equine and companion-animal wound care
Medium-term outlook	Flat to declining volume, with intermittent supply-driven price movements
Long-term outlook	Continued commoditization and substitution by modern wound-care products

Revenue upside is more likely to come from distribution expansion, packaging, combination products, or veterinary channel penetration than from price increases. Manufacturers may obtain better margins through branded packaging, clinic relationships, or proprietary dressings, but standard nitrofurazone ointment remains vulnerable to price competition.

What licensing deals involve nitrofurazone?

No major recent licensing transaction involving nitrofurazone is publicly prominent. The drug’s age and low commercial value make conventional patent licensing unattractive.

Commercial arrangements are more likely to involve:

• contract manufacturing;
• private-label supply;
• regional distribution;
• veterinary wholesaler agreements;
• product transfers between generic companies;
• licensing of a delivery system rather than the nitrofurazone molecule.

A licensing deal covering nitrofurazone alone would likely reflect geographic distribution, regulatory rights, or manufacturing capacity rather than high-value intellectual property.

What geographic markets are relevant to nitrofurazone?

The United States remains relevant for veterinary topical products, particularly equine care. Europe and other regulated markets impose tighter controls on nitrofuran residues in food-producing animals. Countries with less restrictive enforcement may have broader informal or veterinary use, but such markets carry higher regulatory and supply-chain risk.

Geographic exposure depends on:

• animal-drug approval status;
• residue rules;
• import controls;
• local veterinary prescribing practices;
• availability of competing antiseptics;
• enforcement against unauthorized aquaculture or food-animal use.

Food-animal and aquaculture applications present the highest regulatory risk. Companion-animal and equine wound care offer a more defensible commercial segment.

Key Takeaways

• Nitrofurazone is an old, off-patent nitrofuran antibacterial with limited modern human-market relevance.
• Current U.S. commercial activity is concentrated in topical veterinary products.
• No significant active composition patent or Orange Book exclusivity protects the molecule.
• No major Paragraph IV campaign or current patent litigation is publicly associated with the drug.
• Veterinary wound care, especially equine use, is the most commercially relevant segment.
• Food-animal and aquaculture applications face substantial residue and regulatory restrictions.
• Standalone revenue data are not publicly disclosed, but the market is best characterized as low-value, fragmented, and mature.
• Financial growth would depend on distribution, branding, formulations, or delivery systems rather than active-ingredient exclusivity.
• Generic entry risk is high, while patent-driven barriers are low.
• Substitution from mupirocin, silver sulfadiazine, chlorhexidine, povidone-iodine, and modern antimicrobial dressings will constrain long-term growth.

FAQs

Is nitrofurazone still sold in the United States?

Yes. Nitrofurazone remains available primarily as a veterinary topical product. Its human-market presence is limited compared with its historical use.

Is nitrofurazone banned in food-producing animals?

U.S. regulations prohibit nitrofurans, including nitrofurazone, from use in food-producing animals under 21 C.F.R. § 530.41. Product labeling and residue rules must be reviewed for each jurisdiction.

Can a company launch a generic nitrofurazone ointment?

A company can pursue a compliant veterinary or human product pathway, depending on the proposed indication and jurisdiction. The principal challenges are regulatory approval, manufacturing quality, labeling, and market access rather than core patent protection.

Does nitrofurazone have antibiotic-resistance concerns?

As an antibacterial product, nitrofurazone contributes to the broader need for appropriate antimicrobial use. Its topical use, limited modern clinical role, and availability of non-antibiotic wound-care products affect its stewardship profile.

Is nitrofurazone commercially attractive for pharmaceutical investors?

As a standalone active ingredient, nitrofurazone offers limited investment appeal. The more defensible opportunities are in veterinary distribution, private-label portfolios, specialized wound dressings, and regulated manufacturing capacity.

References

1. U.S. Food and Drug Administration. (n.d.). Animal drugs at FDA: Nitrofurazone product information. Center for Veterinary Medicine.
2. Electronic Code of Federal Regulations. (n.d.). 21 C.F.R. § 524.1580: Nitrofurazone.
3. Electronic Code of Federal Regulations. (n.d.). 21 C.F.R. § 530.41: Drugs prohibited for extralabel use in animals.
4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations. Orange Book.
5. National Center for Biotechnology Information. (n.d.). PubChem compound summary: Nitrofurazone. PubChem.
6. U.S. Food and Drug Administration. (n.d.). Green Book: FDA-approved animal drug products. Center for Veterinary Medicine.