FURADANTIN Drug Patent Profile

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

Furadantin is a drug marketed by Casper Pharma Llc and Procter And Gamble and is included in two NDAs.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Furadantin

A generic version of FURADANTIN was approved as nitrofurantoin by IMPAX LABS INC on January 28^th, 1993.

Summary for FURADANTIN

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	2
Patent Applications:	5,701
Drug Prices:	Drug price information for FURADANTIN
What excipients (inactive ingredients) are in FURADANTIN?	FURADANTIN excipients list
DailyMed Link:	FURADANTIN at DailyMed

See drug prices for FURADANTIN

Recent Clinical Trials for FURADANTIN

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

Sponsor	Phase
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine	Early Phase 1
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi	Phase 3
Ministero della Salute, Italy	Phase 3

See all FURADANTIN clinical trials

US Patents and Regulatory Information for FURADANTIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Casper Pharma Llc	FURADANTIN	nitrofurantoin	SUSPENSION;ORAL	009175-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Procter And Gamble	FURADANTIN	nitrofurantoin	TABLET;ORAL	008693-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Casper Pharma Llc	FURADANTIN	nitrofurantoin	SUSPENSION;ORAL	009175-002	Jun 9, 2023		RX	Yes	Yes
Procter And Gamble	FURADANTIN	nitrofurantoin	TABLET;ORAL	008693-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Furadantin Market Dynamics, Financial Trajectory, Patents, and Generic Competition

Last updated: September 24, 2026

Furadantin is the branded oral suspension form of nitrofurantoin, an older antibacterial used primarily for uncomplicated lower urinary tract infections. Its commercial market is mature, low-growth, and generic-led. The product’s value is concentrated in pediatric and adult patients who cannot use capsules or tablets, rather than in broad antibiotic demand.

No reliable public source reports standalone Furadantin sales, operating profit, or market share. The product is generally sold through private-label, specialty, or generic distribution channels, and company filings do not separately disclose Furadantin revenue. Its financial trajectory is therefore best assessed through prescription demand, generic competition, supply conditions, pricing, and the continuing clinical need for an oral liquid nitrofurantoin product.

What is Furadantin and how is it used?

Furadantin is nitrofurantoin oral suspension, USP. The product is indicated for the treatment or suppression of urinary tract infections caused by susceptible organisms. Nitrofurantoin is concentrated in urine and is used mainly for lower urinary tract infections, not pyelonephritis or systemic infections.

The labeled suspension concentration is 25 mg per 5 mL. The formulation allows dosing when patients cannot swallow capsules or tablets, including some children, older adults, and patients with enteral administration requirements. The principal commercial substitutes are:

• Generic nitrofurantoin monohydrate/macrocrystals capsules, commonly associated with Macrobid.
• Generic nitrofurantoin macrocrystals capsules, commonly associated with Macrodantin.
• Other oral liquid nitrofurantoin products, where available.
• Alternative urinary antibiotics such as trimethoprim-sulfamethoxazole, fosfomycin, and selected beta-lactams.

Furadantin is not interchangeable with every nitrofurantoin dosage form on a milligram-for-milligram basis. Formulation, dosing frequency, tolerability, and prescribing considerations differ.

How large is the Furadantin market?

The standalone Furadantin market is likely small relative to the overall nitrofurantoin market. Demand is constrained by the product’s narrow dosage-form role and by the availability of low-cost nitrofurantoin capsules.

Public prescription databases and company filings generally aggregate nitrofurantoin products or report sales at a broader portfolio level. They do not provide a dependable, audited Furadantin revenue series. A precise market-size estimate would therefore overstate the quality of available data.

Market structure

Market characteristic	Furadantin implication
Therapeutic area	Urinary tract infection
Active ingredient	Nitrofurantoin
Dosage form	Oral suspension
Primary differentiation	Liquid administration
Product age	Legacy product
Competition	Generic capsules and possible liquid alternatives
Reimbursement	Primarily generic or low-cost formulary positioning
Pricing power	Limited in routine pharmacy channels
Demand profile	Stable, episodic, infection-driven
Revenue visibility	Low; standalone sales are not publicly disclosed

The broader nitrofurantoin market benefits from continued guideline support for uncomplicated cystitis and from antimicrobial stewardship policies that favor narrow-spectrum agents when clinically appropriate. Furadantin captures only the portion of this demand requiring a liquid dosage form.

What is Furadantin’s financial trajectory?

Furadantin’s revenue trajectory is likely mature to declining in nominal terms, with periodic increases caused by price changes or supply disruptions rather than sustained volume growth.

Three forces determine the product’s financial performance:

1. Stable clinical demand for nitrofurantoin.
2. Low unit prices for competing generic capsules.
3. A small but defensible liquid-dosage-form niche.

The product can generate attractive gross margins during periods of limited supply, but those gains are vulnerable to new entrants, contract-manufacturing changes, procurement pressure, and payer substitution. A liquid antibiotic also carries higher packaging, stability, shipping, and manufacturing costs than a solid oral dosage form.

Revenue drivers

Furadantin demand is supported by:

• Pediatric urinary tract infections where liquid dosing is clinically or practically necessary.
• Patients with dysphagia or feeding tubes.
• Prescriptions from hospitals and long-term-care facilities requiring liquid administration.
• Shortages or back orders affecting competing nitrofurantoin products.
• Clinicians seeking a labeled nitrofurantoin suspension rather than extemporaneous compounding.

Revenue is constrained by:

• The short treatment duration for uncomplicated cystitis.
• Low generic reimbursement rates.
• Capsule availability for most adults.
• Substitution with other antibiotics when nitrofurantoin is unsuitable.
• Renal-function restrictions and contraindications.
• Limited treatment utility for upper-tract or systemic infections.

The product’s economics are therefore niche and volume-sensitive. A modest change in liquid-product availability can materially affect sales, but the addressable patient population remains limited.

What is the FDA regulatory status of Furadantin?

Furadantin is an FDA-approved nitrofurantoin oral suspension product. The product is associated with legacy approval history rather than a recent new-drug development program. Nitrofurantoin products are subject to labeling requirements covering pulmonary reactions, hepatotoxicity, peripheral neuropathy, hemolytic anemia, renal-function limitations, and other safety risks.

The FDA label states that nitrofurantoin should not be used for suspected pyelonephritis or other systemic infections because tissue and blood concentrations are inadequate for those indications. The label also includes important renal restrictions and warnings for long-term use (U.S. Food and Drug Administration, n.d.-a).

Furadantin’s commercial position is not driven by regulatory exclusivity. Its market status reflects approval of an old active ingredient and continued availability of a liquid formulation.

FDA exclusivity position

No meaningful period of new-drug exclusivity is expected to remain for Furadantin. The product’s commercial protection does not depend on five-year new chemical entity exclusivity, three-year clinical-investigation exclusivity, or pediatric exclusivity.

The relevant competitive barriers are product-specific manufacturing requirements, regulatory approval of an oral suspension, supply continuity, and distribution access.

What patents protect Furadantin?

Furadantin is based on nitrofurantoin, an old active ingredient whose original composition-of-matter and early product protections expired decades ago. No material, unexpired U.S. patent estate is generally associated with the basic Furadantin product.

The commercial product may have historically been associated with formulation, manufacturing, packaging, or labeling rights, but legacy patents of that type do not provide meaningful current exclusivity unless a specific, unexpired patent is listed and enforceable. Publicly available FDA Orange Book data should be checked for current patent listings tied to the relevant NDA and dosage form (U.S. Food and Drug Administration, n.d.-b).

Patent and exclusivity assessment

Protection category	Current commercial significance
Nitrofurantoin composition patent	Expired
Original Furadantin product protection	Expired or no longer material
New chemical entity exclusivity	Expired
Pediatric exclusivity	Expired, if previously granted
Formulation patent	No generally recognized active barrier
Method-of-use patent	No material barrier identified
Manufacturing patent	Potentially relevant only if product-specific and unexpired
Trade secret or know-how	May affect supply but does not block approved competitors

Furadantin therefore presents low patent risk to an approved generic entrant. The larger risks are regulatory execution, formulation development, bioequivalence or equivalent-performance requirements, and commercial scale.

How many patents cover Furadantin in the Orange Book?

Furadantin should be treated as having no meaningful active Orange Book patent barrier unless the current Orange Book entry for the specific NDA identifies an unexpired listing. Legacy products can have historical listings, but historical listings do not create current exclusivity after expiration.

The Orange Book is the controlling source for listed patents and therapeutic-equivalence information. A patent analysis should distinguish among:

• Expired patents.
• Delisted patents.
• Process patents with limited product relevance.
• Method-of-use patents.
• Active patents that could trigger a Paragraph IV certification.

There is no known market structure in which Furadantin’s commercial value depends on a live, blocking patent portfolio.

When does Furadantin lose exclusivity?

Furadantin lost meaningful statutory exclusivity long ago. Nitrofurantoin has been marketed for more than 70 years, and the relevant compound and early product rights are expired.

The current commercial situation is not an upcoming loss-of-exclusivity event. It is a mature generic market in which profitability depends on continued supply, pharmacy contracting, and the limited differentiation of an oral suspension.

Milestone	Timing or status
Nitrofurantoin introduction	1950s
Furadantin approval history	Legacy FDA approval
Original patent protection	Expired
New-drug exclusivity	Expired
Generic competition	Established
Current exclusivity cliff	None material
Main commercial risk	Price and supply competition

Are there Paragraph IV challenges to Furadantin?

A conventional Paragraph IV litigation cycle is unlikely to be commercially important for Furadantin because the core product is already an old, genericized medicine. Paragraph IV certifications matter when an ANDA applicant challenges an unexpired Orange Book patent. They do not create meaningful market protection where no blocking patent remains.

Potential ANDA activity could still involve an oral suspension, but the legal pathway would more likely center on product approval, labeling, formulation performance, and therapeutic equivalence than on a high-value patent dispute.

No major, publicly prominent Furadantin Paragraph IV settlement is generally associated with the product. A definitive litigation conclusion requires review of the current Orange Book, FDA approval records, and federal court dockets.

What formulation patents protect nitrofurantoin oral suspension?

The liquid dosage form may require formulation know-how involving:

• Suspension uniformity.
• Particle-size control.
• Sedimentation and redispersion.
• Taste masking.
• Chemical and physical stability.
• Preservative performance.
• Container compatibility.
• Dosing-device accuracy.

These technical requirements can raise development costs without creating durable patent exclusivity. A competitor may be able to design around formulation claims or rely on a different excipient system.

For an oral suspension, manufacturing consistency is more important commercially than the existence of a broad active patent estate. A product that settles rapidly, is difficult to resuspend, or has poor palatability can lose pharmacy and prescriber acceptance even if it meets formal regulatory requirements.

Which companies compete with Furadantin?

Competition comes from two groups: manufacturers of alternative nitrofurantoin products and manufacturers of substitute antibiotics.

Nitrofurantoin competition

Generic manufacturers and distributors have marketed nitrofurantoin monohydrate/macrocrystals and macrocrystal capsules. The major commercial reference products are Macrobid and Macrodantin, although the branded products are not direct liquid substitutes.

The competitive advantage of capsules is cost and availability. Furadantin’s advantage is administration flexibility.

Therapeutic competition

Furadantin competes indirectly with:

• Fosfomycin tromethamine.
• Trimethoprim-sulfamethoxazole.
• Cephalexin and other oral beta-lactams.
• Amoxicillin-clavulanate.
• Fluoroquinolones, although stewardship considerations limit their use for uncomplicated cystitis.

Treatment selection depends on local resistance, patient history, renal function, pregnancy status, infection site, allergy profile, and guideline recommendations (Gupta et al., 2011).

What generic launch risks exist for Furadantin?

A new generic liquid entrant could pressure Furadantin through lower pricing and broader wholesaler access. The risk is higher if the entrant obtains reliable supply and a favorable reimbursement position.

Generic entry scenarios

Scenario	Market effect
One additional liquid competitor	Moderate price pressure; limited volume displacement
Several liquid competitors	Significant reimbursement and contracting pressure
Capsule shortage	Temporary volume and pricing benefit for liquid products
Liquid manufacturing disruption	Rapid loss of prescriptions and possible therapeutic substitution
New pediatric-focused formulation	Potential erosion of Furadantin’s niche
Hospital or payer contract loss	Disproportionate impact because the market is small

The absence of a strong patent estate makes entry legally feasible. The main barriers are formulation development, FDA review, manufacturing validation, product liability exposure, and the need to secure economical commercial distribution.

What manufacturing and intellectual-property barriers affect Furadantin?

Furadantin has low conventional patent strength but moderate operational sensitivity. A manufacturer must control the active ingredient’s particle characteristics, suspension stability, microbiological quality, packaging, and dosing performance.

Supply-chain exposure may arise from:

• Dependence on a limited number of nitrofurantoin API suppliers.
• Specialized oral-liquid manufacturing capacity.
• Packaging-component shortages.
• Low production volumes that reduce manufacturing priority.
• Short shelf life or stability constraints.
• Pharmacy and wholesaler inventory decisions.

For a low-volume product, fixed manufacturing and regulatory costs are spread across fewer units. This can make entry unattractive even when patent barriers are absent.

What is the biosimilar risk for Furadantin?

There is no biosimilar risk. Furadantin is a small-molecule antibacterial, not a biologic. Competitors enter through generic-drug pathways rather than the FDA biosimilar pathway under the Public Health Service Act.

The relevant competitive threats are ANDA-approved generic products, authorized generics, alternate liquid formulations, and therapeutic substitutes.

What is the litigation status for Furadantin?

Furadantin does not have the litigation profile of a recently launched branded medicine. No major, high-value patent litigation campaign is generally associated with its current commercial position.

The most relevant legal issues are likely to involve:

• ANDA patent certifications, if any active listing exists.
• Product liability claims related to nitrofurantoin safety warnings.
• Manufacturing or supply agreements.
• Labeling and regulatory compliance.
• Antitrust or pricing issues affecting generic distribution.

Without a current docket-specific review, no active case should be treated as a material Furadantin valuation driver.

What licensing deals affect Furadantin?

No major publicly disclosed licensing transaction is widely associated with Furadantin’s current economics. Legacy rights may have moved among brand owners, generic manufacturers, distributors, or specialty pharmaceutical companies, but transaction values and product-level royalties are generally not disclosed.

The absence of a visible licensing deal is consistent with the product’s mature status. Furadantin is more likely to be managed as a portfolio or supply-chain asset than as a strategic innovation product.

How does Furadantin compare with Macrobid and generic nitrofurantoin?

Attribute	Furadantin	Macrobid and generic equivalents
Dosage form	Oral suspension	Capsules
Main patient need	Liquid administration	Standard adult oral dosing
Patent position	Legacy, no material active barrier	Genericized product class
Market size	Narrow niche	Broader nitrofurantoin market
Price pressure	High but may vary with supply	Very high
Pediatric usability	More suitable	Limited by swallowing and dosing
Manufacturing complexity	Higher because of suspension	Lower relative to liquid
Commercial differentiation	Dosage form	Availability, price, contracting
Biosimilar exposure	None	None

Furadantin has a stronger formulation niche than capsule products but a weaker scale position. Macrobid and generic capsules capture most routine adult demand because they are familiar, inexpensive, and widely distributed.

What is the geographic coverage of Furadantin?

Furadantin’s most commercially relevant market is the United States, where FDA labeling and Orange Book status determine approval and substitution. International nitrofurantoin markets may use different brands, concentrations, regulatory classifications, or liquid products.

Geographic expansion is limited by:

• Country-specific approval requirements.
• Different antimicrobial guidelines.
• Pediatric dosage-form preferences.
• Local reimbursement.
• Availability of nitrofurantoin API and liquid manufacturing.
• National rules governing generic substitution.

A U.S. Furadantin assessment should not be extrapolated directly to Europe, Canada, or emerging markets without country-level product and reimbursement data.

Key Takeaways

• Furadantin is nitrofurantoin oral suspension, a mature product for urinary tract infections.
• Its commercial value comes from liquid administration, not active-ingredient exclusivity.
• The product has no meaningful remaining new-drug or composition-of-matter exclusivity.
• Patent risk is low, while manufacturing and supply-chain risk are more relevant.
• Standalone revenue, profit, and market-share figures are not publicly disclosed.
• The likely financial trajectory is stable to declining volume, with intermittent price effects from shortages or limited competition.
• Generic capsules are the primary competitive threat in adults.
• Other liquid nitrofurantoin products could create meaningful pricing pressure.
• Furadantin has no biosimilar risk because nitrofurantoin is a small molecule.
• No major Paragraph IV settlement or patent-litigation campaign is a central commercial feature of the product.

FAQs about Furadantin market and patent exposure

Is Furadantin still commercially available?

Furadantin has been marketed as nitrofurantoin oral suspension, but product availability can vary by manufacturer, wholesaler inventory, and pharmacy supply. Current availability should be assessed through FDA drug databases and commercial wholesaler listings.

Is Furadantin more expensive than generic nitrofurantoin capsules?

Usually, the liquid dosage form carries higher per-dose or per-treatment costs because oral suspensions have more complex manufacturing, packaging, and distribution requirements. The actual patient price depends on payer coverage, pharmacy pricing, and product availability.

Can a generic company launch a liquid nitrofurantoin product without licensing Furadantin?

Yes. A company can pursue its own FDA-approved oral suspension through the applicable generic pathway if it satisfies FDA requirements and no enforceable blocking patent remains.

Does Furadantin have pediatric market exclusivity?

No material pediatric exclusivity is expected to remain for this legacy product. Pediatric use can support demand, but it does not by itself create current statutory exclusivity.

What is the main investment risk associated with Furadantin?

The principal risk is commercial erosion from generic liquid competition, reimbursement pressure, or supply disruption. Patent litigation is a secondary risk because Furadantin does not depend on a significant active patent estate.

References

1. Gupta, K., Hooton, T. M., Naber, K. G., Wullt, B., Colgan, R., Miller, L. G., Moran, G. J., Nicolle, L. E., Raz, R., Schaeffer, A. J., & Soper, D. E. (2011). International clinical practice guidelines for the treatment of acute uncomplicated cystitis and pyelonephritis in women. Clinical Infectious Diseases, 52(5), e103-e120. https://doi.org/10.1093/cid/ciq257

2. U.S. Food and Drug Administration. (n.d.-a). Furadantin: Nitrofurantoin oral suspension prescribing information. DailyMed. https://dailymed.nlm.nih.gov/

3. U.S. Food and Drug Administration. (n.d.-b). Approved drug products with therapeutic equivalence evaluations, Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm