Generic PROBENECID INN entry, drug patent expiration information and freedom to operate

Sponsor	Phase
Fondation Ophtalmologique Adolphe de Rothschild	PHASE2
Brown University	PHASE2
Pfizer	PHASE1

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Iterum Therap	ORLYNVAH	probenecid; sulopenem etzadroxil	TABLET;ORAL	213972-001	Oct 25, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Iterum Therap	ORLYNVAH	probenecid; sulopenem etzadroxil	TABLET;ORAL	213972-001	Oct 25, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Iterum Therap	ORLYNVAH	probenecid; sulopenem etzadroxil	TABLET;ORAL	213972-001	Oct 25, 2024		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Last updated: September 9, 2026

Probenecid is a mature, low-cost generic medicine with limited commercial growth potential. The active ingredient is approved in the United States for gout and hyperuricemia and as an adjunct to extend penicillin-class antibiotic exposure. Its patent estate is effectively historical, no biosimilar pathway applies, and no material branded exclusivity remains. Market value is driven by manufacturing reliability, wholesaler access, institutional demand, and pricing rather than innovation or patent protection.

What is probenecid approved for?

Probenecid is an oral uricosuric drug that reduces renal tubular reabsorption of uric acid. It increases urinary uric acid excretion and lowers serum urate in appropriate patients with gout or hyperuricemia. It is also used to increase and prolong plasma concentrations of certain penicillin antibiotics by reducing renal tubular secretion.[1]

Attribute	Probenecid
Active ingredient	Probenecid
Drug class	Uricosuric agent; renal tubular secretion inhibitor
Main dosage form	Oral tablets, commonly 500 mg
FDA status	Approved prescription drug
Primary use	Chronic gout and hyperuricemia
Secondary use	Adjunct to selected penicillin antibiotics
Biologic status	Small molecule
Biosimilar pathway	Not applicable
Current market structure	Generic and multisource
Patent position	Legacy patents expired or commercially immaterial

Probenecid is not generally used to treat an acute gout attack by itself. The FDA label recommends initiating therapy at a low dose and increasing it according to response and tolerability. Adequate hydration and urine alkalinization may be relevant because increased uric acid excretion can contribute to urinary tract stone formation.[1]

When does probenecid lose exclusivity?

Probenecid lost meaningful market exclusivity decades ago. It was developed and commercialized before the modern Hatch-Waxman framework, and its core composition-of-matter protection is long expired.

The commercial consequences are material:

No current branded probenecid franchise controls the market.
Generic manufacturers can compete primarily through an abbreviated or legacy approval pathway.
Pricing depends on the number of active suppliers and the availability of approved inventory.
Product differentiation is limited because the dominant presentation is an immediate-release oral tablet.
Patent-based barriers do not materially restrict generic entry.

The FDA Orange Book remains the principal source for checking approved products, therapeutic equivalence and any listed patents or exclusivity. Current probenecid products do not have the type of active, commercially significant patent listings associated with newer small-molecule drugs.[2]

What is the Orange Book status of probenecid?

Probenecid is represented as a multisource generic product rather than a protected branded medicine. Orange Book relevance is therefore regulatory rather than defensive. The listing helps identify approved applicants and therapeutic-equivalence designations, but it does not create a meaningful barrier to additional generic manufacturers.

Because probenecid is an old active ingredient, the key commercial question is not whether a patent blocks entry. It is whether a manufacturer can maintain FDA-compliant supply at a price that supports production, distribution and quality operations.

What patents protect probenecid?

No commercially important unexpired composition patent is expected to protect probenecid in the United States. Historical patents covering the molecule, early formulations or original therapeutic uses have expired.

The current patent risk profile is summarized below.

Patent category	Current commercial relevance
Composition of matter	None expected to remain in force
Basic oral tablet formulation	None expected to block generic supply
Gout treatment method	No meaningful exclusivity barrier
Penicillin pharmacokinetic use	Historical and commercially weak
Manufacturing process	Potentially relevant only to a specific supplier, not the molecule
Device or delivery system	Not a material feature of the established product
Orange Book patents	No material active listing generally associated with the generic market

A manufacturer could still own confidential manufacturing know-how, process controls, impurity specifications or supply contracts. Those rights are not equivalent to an enforceable product patent and usually do not prevent competition.

What formulations are protected by probenecid patents?

The commercial formulation is typically a conventional immediate-release tablet. No widely recognized active formulation patent gives a company control over the probenecid market.

A new extended-release formulation, fixed-dose combination or alternative delivery system could theoretically generate new intellectual property. Such a product would need to establish clinical, pharmacokinetic or adherence advantages over low-cost generic tablets. The commercial case would be difficult because the existing product has a low acquisition cost and long clinical history.

Are there Paragraph IV challenges for probenecid?

Paragraph IV litigation is not a significant current market issue for probenecid. Paragraph IV certifications generally matter when a new generic applicant challenges unexpired patents listed for an approved reference product. Probenecid lacks the type of active branded patent portfolio that normally generates repeated Paragraph IV litigation.

The likely entry pattern is therefore regulatory and commercial rather than contentious:

A manufacturer obtains or maintains an abbreviated approval.
The manufacturer enters after satisfying FDA requirements.
Wholesaler and pharmacy contracts determine practical market access.
Shortages or supplier exits can increase prices temporarily.
Additional suppliers tend to compress prices again.

No major, current settlement structure is associated with probenecid comparable to the settlements seen in high-value branded products.

What is the FDA regulatory status of probenecid?

Probenecid is an FDA-approved prescription drug. The regulatory risk is concentrated in product quality, manufacturing compliance and supply continuity rather than clinical novelty.

FDA-approved uses and labeling constraints

The approved label identifies treatment of chronic gout and hyperuricemia in patients with frequent gout attacks or clinically meaningful urate burden. It also identifies use with certain penicillins to prolong antibiotic exposure.[1]

Important label-based limitations include:

It is not appropriate for every patient with impaired renal function.
It can increase the risk of uric acid nephrolithiasis.
It has clinically significant interactions with drugs cleared by renal tubular secretion.
Salicylates can reduce or counteract its uricosuric effect.
Dose escalation must account for tolerability and urate response.

The FDA label also identifies interactions involving methotrexate, ketorolac, certain antibiotics and other renally handled medicines. This interaction profile can limit use in patients with polypharmacy.[1]

How strong is the probenecid patent estate?

The patent estate is weak from a market-exclusion perspective but still relevant to product strategy.

Strength factor	Assessment
Core molecule protection	Expired
Active branded exclusivity	None of material significance
Generic substitution	High
Formulation differentiation	Limited
Manufacturing barriers	Moderate at the supplier level
Clinical switching barriers	Low to moderate
Litigation exposure	Low
Pricing power	Low
Regulatory complexity	Moderate because of interactions and quality requirements

Probenecid has a low patent moat and a modest operational moat. The main barriers are not intellectual property rights. They are FDA manufacturing compliance, reliable active pharmaceutical ingredient supply, dissolution and stability performance, and the economics of producing a low-volume generic tablet.

What companies manufacture or compete with probenecid?

The U.S. market is supplied by generic manufacturers and repackagers rather than a single dominant innovator. Approved suppliers can change over time as companies enter, exit or transfer product rights.

The competitive set includes:

Generic probenecid tablet manufacturers.
Repackagers that purchase finished product from approved manufacturers.
Gout therapies such as allopurinol and febuxostat.
Urate-lowering therapies used in patients who cannot tolerate or do not respond to uricosuric treatment.
Combination products containing probenecid and an antibiotic, where available.

Allopurinol is the principal therapeutic comparator in chronic gout. It reduces uric acid production through xanthine oxidase inhibition, while probenecid increases uric acid excretion. Febuxostat provides another xanthine oxidase inhibitor option. The choice depends on renal function, cardiovascular considerations, prior intolerance, stone risk, disease severity and prescribing guidelines.[3]

How does probenecid compare with allopurinol and febuxostat?

Factor	Probenecid	Allopurinol	Febuxostat
Mechanism	Increases uric acid excretion	Reduces uric acid production	Reduces uric acid production
Generic availability	Yes	Yes	Yes in many markets
Renal considerations	Less attractive with significant renal impairment	Dose adjustment often required	Dose and safety assessment required
Stone risk	Increased urinary uric acid can raise risk	Does not act by increasing uric acid excretion	Does not act by increasing uric acid excretion
Patent moat	None material	None material for core drug	Historical branded protection largely expired
Commercial position	Niche, low-cost	Standard first-line comparator	Alternative for selected patients

Clinical guidelines commonly place allopurinol ahead of probenecid in many patients, especially where chronic kidney disease or high urate burden affects treatment selection.[3] That positioning limits probenecid volume growth even when the product remains clinically useful.

What is the financial trajectory for probenecid?

Probenecid has a mature generic financial profile. Revenue is likely to remain low relative to newer gout medicines, with limited prospect of sustained top-line growth absent a new formulation, combination product or expanded indication.

Financial driver	Expected effect
Low generic price	Limits revenue per prescription
Multiple suppliers	Compresses gross margin
Small clinical niche	Restricts volume growth
Chronic-use potential	Supports recurring prescriptions
Supply interruptions	Can create temporary price increases
Lack of brand promotion	Limits market expansion
Low research spending	Supports cash generation for established suppliers
Limited differentiation	Reduces licensing value

Public company filings generally do not disclose probenecid revenue as a standalone product line. It is often grouped within broader generic portfolios. As a result, precise global sales estimates are less reliable than estimates for branded therapies with dedicated reporting segments.

The most probable financial trajectory is stable-to-declining real revenue, with periodic volatility caused by supplier concentration or shortages. A manufacturer may earn attractive contribution margins during periods of constrained supply, but those margins are vulnerable to new entrants and contract repricing.

What revenue exposure exists for manufacturers?

Probenecid is unlikely to be a material revenue driver for diversified pharmaceutical companies. Its financial significance is higher for:

Small generic companies with concentrated product portfolios.
Contract manufacturers serving niche oral solid-dose products.
Repackagers that benefit from supply relationships.
Distributors managing intermittent shortages.
Companies holding a broad basket of older generic medicines.

The product can have strategic value even with modest revenue if it uses existing tablet manufacturing capacity, shares packaging infrastructure or fills a portfolio gap in rheumatology and primary care.

What manufacturing and intellectual-property barriers affect probenecid?

The principal manufacturing barriers are operational:

Consistent active pharmaceutical ingredient supply.
Control of impurities and degradation products.
Tablet dissolution and content uniformity.
Stability through the labeled shelf life.
FDA-compliant documentation and change control.
Ability to maintain supply at low market prices.

Probenecid does not require cold-chain distribution, complex biologic manufacturing or specialized delivery equipment. That lowers technical entry barriers. The economic barrier is more important: a supplier must operate efficiently enough to justify a low-volume product with limited pricing power.

Geographic API sourcing can affect the market through inspection findings, export controls, freight disruptions and supplier concentration. Finished-dose production may occur in the United States, India, Europe or other manufacturing hubs, while the API supply chain can be more geographically concentrated.

What generic launch scenarios exist for probenecid?

The realistic launch scenarios are operational rather than patent-driven.

Stable multisource market

Several suppliers maintain approval and inventory. Prices remain low, pharmacy access is routine and no manufacturer has meaningful pricing power.

Supplier exit

One or more manufacturers discontinue the product. Remaining suppliers gain share and may raise prices, particularly if wholesalers hold limited inventory.

Shortage-driven opportunity

A new or returning supplier enters when market availability deteriorates. The opportunity is strongest for companies with an existing FDA-approved facility and efficient analytical transfer capabilities.

Reformulated product launch

A company introduces a modified-release or combination product. Commercial success would depend on clinical differentiation, reimbursement and the ability to justify a premium over generic immediate-release tablets.

New indication development

A sponsor investigates probenecid for an infectious disease or other condition. Historical repurposing interest has included antiviral research, but investigational activity has not created an FDA-approved new commercial indication.[4]

What litigation affects probenecid?

Probenecid has low current patent-litigation exposure. The relevant legal risks are more likely to involve:

Product liability.
Manufacturing defects.
Labeling and failure-to-warn claims.
FDA compliance.
Supply or distribution contracts.
Antitrust issues arising from generic pricing conduct.

There is no established pattern of high-value patent settlements controlling U.S. generic entry. The absence of branded exclusivity makes probenecid materially different from protected medicines facing repeated Abbreviated New Drug Application challenges.

What is the geographic coverage of probenecid?

Probenecid has a long history of use in the United States and other markets, but availability varies by jurisdiction. Regulatory status, reimbursement, local prescribing patterns and supplier participation determine commercial presence.

The United States has a mature generic market. Other markets may rely on local generic manufacturers, imported finished product or limited national approvals. International expansion would generally offer modest value unless a sponsor can secure registration, distribution and reimbursement without creating excessive regulatory overhead.

Key Takeaways

Probenecid is an FDA-approved, mature generic drug used mainly for chronic gout and hyperuricemia.
Its core patents and historical exclusivity have expired.
The Orange Book is relevant for identifying approved suppliers, not for preserving a meaningful patent barrier.
Paragraph IV litigation and patent settlements are not major current risks.
The product has no biosimilar exposure because it is a conventional small molecule.
Allopurinol and febuxostat limit probenecid’s growth in chronic urate-lowering therapy.
Revenue is likely modest, fragmented and generally undisclosed on a standalone basis.
Financial performance depends on supply continuity, manufacturing efficiency and temporary shortage conditions.
The strongest commercial opportunity would arise from a supply-constrained market, not from core-molecule patent protection.
A new formulation or indication would require meaningful clinical and economic differentiation.

FAQs

Is probenecid still commercially available in the United States?

Yes. Probenecid remains available as a generic prescription tablet, although supplier participation and inventory can change over time.

Can a company obtain new patents on probenecid?

Yes, a company could seek patents on a novel formulation, combination, manufacturing process or therapeutic use. Such patents would not restore exclusivity to the existing immediate-release product unless they covered a commercially necessary feature.

Is probenecid a specialty pharmaceutical?

It is generally not classified as a high-value specialty pharmaceutical. It is an older oral generic medicine used in a defined patient population.

Does probenecid have orphan-drug potential?

The established gout indication is not an orphan indication. A separate rare-disease use could potentially qualify for orphan designation only if it met FDA statutory and regulatory criteria, but no established orphan exclusivity currently defines the probenecid market.

Could probenecid become more valuable through drug repurposing?

Repurposing could increase value only if a new use demonstrates clinical benefit and obtains regulatory approval or achieves substantial off-label adoption. Research interest alone does not create market exclusivity or a reliable revenue stream.

References

U.S. Food and Drug Administration. (n.d.). Probenecid tablet prescribing information. DailyMed. https://dailymed.nlm.nih.gov/dailymed/
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book
FitzGerald, J. D., Dalbeth, N., Mikuls, T., Brignardello-Petersen, R., Guyatt, G., Abeles, A. M., Andrade-Ortega, L., Khanna, D., King, C., Levy, G., Libbey, C., Mount, D., Pillinger, M. H., Rosenthal, A., Singh, J. A., Sims, J. E., Smith, B. J., Wenger, N. S., Bae, S. S., ... Neogi, T. (2020). 2020 American College of Rheumatology guideline for the management of gout. Arthritis Care & Research, 72(6), 744-760. https://doi.org/10.1002/acr.24180
National Institutes of Health. (n.d.). ClinicalTrials.gov. Probenecid studies. https://clinicaltrials.gov/

US Patents:	5
Tradenames:	4
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	76
Patent Applications:	7,402
Drug Prices:	Drug price trends for probenecid
What excipients (inactive ingredients) are in probenecid?	probenecid excipients list
DailyMed Link:	probenecid at DailyMed

Probenecid - Generic Drug Details

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US Patents and Regulatory Information for probenecid

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