ALLOPURINOL SODIUM Drug Patent Profile

When do Allopurinol Sodium patents expire, and what generic alternatives are available?

Allopurinol Sodium is a drug marketed by Gland and Hikma and is included in two NDAs.

The generic ingredient in ALLOPURINOL SODIUM is allopurinol sodium. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Allopurinol Sodium

A generic version of ALLOPURINOL SODIUM was approved as allopurinol sodium by HIKMA on August 26^th, 2004.

Summary for ALLOPURINOL SODIUM

US Patents:	0
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	11
Patent Applications:	328
DailyMed Link:	ALLOPURINOL SODIUM at DailyMed

Recent Clinical Trials for ALLOPURINOL SODIUM

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

Sponsor	Phase
Huashan Hospital	PHASE4
Fondazione Schena	Phase 4
University of Bari	Phase 4

See all ALLOPURINOL SODIUM clinical trials

Pharmacology for ALLOPURINOL SODIUM

Drug Class	Xanthine Oxidase Inhibitor
Mechanism of Action	Xanthine Oxidase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ALLOPURINOL SODIUM

M04AA	Preparations inhibiting uric acid production
M04A	ANTIGOUT PREPARATIONS
M04	ANTIGOUT PREPARATIONS
M	Musculo-skeletal system

US Patents and Regulatory Information for ALLOPURINOL SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gland	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	212363-001	Jan 26, 2022	AP	RX	No	No
Hikma	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	076870-001	Aug 26, 2004	AP	RX	No	No

Allopurinol Sodium Market Dynamics, Patent Status, FDA History, and Financial Trajectory

Last updated: August 1, 2026

Allopurinol sodium is the injectable sodium salt of allopurinol, used when oral therapy is impractical for patients requiring urate-lowering treatment, including certain oncology-related hyperuricemia settings. Its U.S. commercial position is mature and limited. The product has no meaningful remaining patent exclusivity, faces generic injectable competition, and is not separately reported in public-company financial statements. Its market value is driven by hospital procurement, shortage risk, oncology use, and product availability rather than by patent pricing power.

What is allopurinol sodium and how is it used?

Allopurinol sodium is an injectable formulation of allopurinol, a xanthine oxidase inhibitor. It reduces uric acid formation by inhibiting the conversion of hypoxanthine and xanthine to uric acid.

The injectable product is intended for patients who cannot take oral allopurinol. The FDA labeling identifies use in patients with leukemia, lymphoma, or solid tumors receiving cancer therapy who are at risk of tumor lysis-related hyperuricemia, and in other situations requiring parenteral administration [1].

Attribute	Allopurinol sodium
Active ingredient	Allopurinol sodium
Pharmacologic class	Xanthine oxidase inhibitor
Dosage form	Powder for solution for injection
Typical strength	500 mg vial
Administration	Intravenous
Principal institutional users	Hospitals, oncology centers, acute-care facilities
Primary clinical role	Hyperuricemia management when oral administration is not appropriate
Reference product	Aloprim
U.S. regulatory pathway	Abbreviated new drug applications and legacy NDA framework
Biosimilar classification	Not applicable; this is a small-molecule drug

Oral allopurinol remains the dominant form of the molecule. The injectable sodium formulation occupies a narrower segment because most chronic gout and hyperuricemia patients can use oral tablets.

What is the FDA status of allopurinol sodium?

The U.S. reference product is associated with Aloprim, an injectable allopurinol product historically approved under NDA 019268. Current commercial listings have included allopurinol sodium injection products supplied by generic manufacturers, including Hikma Pharmaceuticals and other institutional suppliers depending on market availability [1][2].

The product is approved as an injectable formulation rather than as a biologic. FDA regulatory exposure therefore involves generic drug applications, manufacturing compliance, sterile production, labeling, and supply continuity. Biosimilar approval standards do not apply.

What FDA milestones affect the product?

Regulatory event	Market significance
Original approval of injectable allopurinol	Established the clinical and regulatory basis for parenteral use
Generic injectable approvals	Removed practical dependence on a single branded supplier
Drug listing and labeling updates	Affect active product availability, warnings, dosage instructions, and package configuration
Manufacturing-site changes	Can alter hospital access and procurement status
Discontinuation or shortage notices	Can shift demand among remaining suppliers

The regulatory status should be evaluated at the product and manufacturer level. A discontinued brand does not necessarily mean that all allopurinol sodium injection products are unavailable. FDA Drug Shortages and DailyMed listings provide the most relevant current operational information [2][3].

What patents protect allopurinol sodium?

No commercially significant patent exclusivity is associated with the mature allopurinol sodium injection market. Allopurinol was discovered and commercialized decades ago, and the active ingredient is long off patent. Any original compound, formulation, or product patents would have expired before the current generic market developed.

Patent category	Current significance
Allopurinol compound patent	Expired
Allopurinol sodium salt protection	No meaningful remaining exclusivity identified for the mature U.S. market
Injectable formulation patent	Any original protection would be expired
Method-of-use patent	No current exclusivity is known to block standard generic use
Manufacturing patent	May affect process implementation but does not create broad product exclusivity
Pediatric exclusivity	No material current effect
Orphan-drug exclusivity	Not a principal market barrier for the product

The relevant commercial question is not whether a patent once existed, but whether an unexpired, enforceable patent is listed or otherwise capable of blocking an FDA-approved generic. For allopurinol sodium injection, the answer is generally no.

What is the Orange Book status of allopurinol sodium?

Orange Book relevance is limited to listed NDA and ANDA products. The Orange Book may identify reference and generic products, application numbers, dosage forms, and patent or exclusivity information when applicable [4].

A mature injectable product with no active listed patents can be challenged through an ANDA without a Paragraph IV certification directed at an unexpired patent. Generic applicants may instead certify that no relevant patent is listed, that a listed patent has expired, or that the applicant will market after the patent expiration date.

When does allopurinol sodium lose exclusivity?

Allopurinol sodium has already lost market exclusivity. The original product is a legacy injectable drug, and any conventional small-molecule patent term has expired.

The product’s current competitive position is determined by:

1. FDA approval and manufacturing compliance.
2. Sterile injectable capacity.
3. Hospital contracts and group purchasing organization access.
4. Availability of active pharmaceutical ingredient.
5. Shortage conditions and supplier reliability.
6. Contract pricing and vial configuration.

There is no credible exclusivity-driven launch window comparable with a recently approved branded drug. A new supplier would compete primarily through an ANDA, manufacturing scale, procurement access, and supply reliability.

Which companies compete in the allopurinol sodium market?

Competition is concentrated among generic injectable manufacturers and distributors. The most visible U.S. commercial association has been Hikma Pharmaceuticals, including its historical West-Ward business, although product availability can change by time period and market channel [2][5].

Potential competitive participants include:

• Hikma Pharmaceuticals.
• Generic injectable manufacturers with approved or marketed allopurinol sodium products.
• Hospital wholesalers and specialty distributors.
• Compounders or outsourcing facilities operating under separate regulatory frameworks, where applicable.

The market is smaller than the oral allopurinol market. It is also more operationally sensitive because injectable products require sterile manufacturing, validated filling operations, quality controls, and hospital distribution.

How does allopurinol sodium compare with oral allopurinol?

Factor	Allopurinol sodium injection	Oral allopurinol
Main setting	Hospital and acute-care use	Chronic outpatient treatment
Administration	Intravenous	Tablet
Patient population	Patients unable to take oral therapy or requiring inpatient treatment	Broad gout and hyperuricemia population
Manufacturing complexity	High due to sterile injectable requirements	Lower relative complexity
Generic competition	Narrower supplier base	Broad supplier base
Revenue profile	Institutional, episodic, low volume	Larger recurring prescription market
Shortage sensitivity	High	Lower relative sensitivity
Patent leverage	None of practical significance	None of practical significance

Oral allopurinol generates the larger volume opportunity. Injectable allopurinol sodium can command a higher price per unit than tablets, but its overall addressable market is much smaller.

What market dynamics determine allopurinol sodium sales?

Allopurinol sodium demand is clinically necessary but commercially constrained. The product is used when an injectable route is required, which limits volume. Demand can rise during oncology treatment cycles, inpatient hyperuricemia management, and periods when oral administration is unsuitable.

Hospital procurement drives the market

Hospitals generally purchase the product through wholesalers, group purchasing organizations, direct contracts, or integrated health-system procurement channels. Contract awards can shift market share even when clinical differentiation is minimal.

Key purchasing criteria include:

• Contract price.
• Reliable backorder performance.
• Vial size and packaging.
• Delivery lead times.
• Quality history.
• Supplier redundancy.
• Reimbursement and formulary treatment.

Sterile manufacturing limits supply elasticity

Sterile injectable products are more difficult to manufacture than oral tablets. A facility interruption, inspection finding, raw-material issue, or fill-finish constraint can materially affect supply. When one manufacturer experiences an interruption, remaining suppliers may gain temporary volume and pricing leverage.

This does not create durable patent power. It creates temporary operational power that can disappear when additional capacity returns.

Clinical substitution limits pricing

Hospitals may substitute oral allopurinol when medically appropriate. In some treatment settings, clinicians may also consider other urate-lowering or uric-acid-management approaches, depending on patient risk, timing, renal function, and the treatment protocol. That limits the ability of an injectable supplier to raise price without losing demand.

What is the financial trajectory for allopurinol sodium?

Allopurinol sodium is a low-growth, mature generic product. Public filings do not generally report its revenue as a standalone line item. Sales are typically included within broader generic, injectables, or U.S. pharmaceutical segments.

Financial factor	Expected effect
Patent expiry	Removes premium pricing and supports generic competition
Small injectable patient base	Limits unit growth
Hospital demand	Creates stable but episodic sales
Sterile supply constraints	Can produce temporary price increases
Multiple suppliers	Pressures long-term gross margin
Contract purchasing	Reduces net pricing
Shortage events	Can increase short-term revenue and share
Oral substitution	Limits sustained expansion
Separate product reporting	Rare, making valuation attribution difficult

The likely financial pattern is mature revenue with intermittent volatility. A supplier can improve performance through market share gains, supply continuity, contract wins, or shortage-related volume. Structural growth is unlikely without a new clinical indication, delivery technology, or supply disruption affecting competitors.

Revenue exposure for generic manufacturers

For a diversified pharmaceutical company, allopurinol sodium is unlikely to be a material revenue driver. Its economic importance can still exceed its sales contribution when the product is part of a hospital injectable portfolio. It may support customer relationships, manufacturing utilization, and procurement-basket participation.

The product could become material to a small supplier if that company has limited injectable breadth. For a large generic manufacturer, its effect is normally diluted across a broader portfolio.

Are there Paragraph IV challenges involving allopurinol sodium?

Paragraph IV litigation is not a central current risk for allopurinol sodium. Paragraph IV certifications are used when an ANDA applicant challenges an unexpired listed patent. The product’s legacy patent position does not present a known current barrier comparable with newer branded medicines.

A future applicant would more likely face commercial and regulatory hurdles involving:

• Bioequivalence and injectable product requirements.
• Sterility assurance.
• Chemistry, manufacturing, and controls review.
• Inspection readiness.
• Active ingredient sourcing.
• Hospital contracting.
• Market access after approval.

The absence of meaningful patent protection increases entry potential but does not guarantee rapid entry. Injectable manufacturing and procurement access can delay or limit commercial uptake.

What generic entry risks exist for allopurinol sodium?

Generic entry risk is already embedded in the market. The principal risk to an incumbent is not a first generic launch but additional suppliers entering a small market.

New entrants could cause:

• Lower contract prices.
• Loss of hospital formulary share.
• Higher rebate or discount requirements.
• Greater inventory pressure.
• Reduced utilization of incumbent manufacturing capacity.
• Greater risk of product discontinuation if margins fall below viable levels.

The countervailing risk is supplier exit. If prices become too low, manufacturers may reduce production or leave the market. That can produce a concentrated market with recurring shortage exposure.

What manufacturing and intellectual-property barriers affect the product?

Manufacturing is the main barrier. Allopurinol sodium injection requires validated sterile processes, appropriate container-closure systems, stability data, quality testing, and compliance with current good manufacturing practices.

Intellectual property is a secondary issue. A supplier may have trade secrets or process know-how, but those rights generally do not prevent competitors from producing an equivalent product through an independent process. Device or packaging rights could matter in a specialized presentation, but the conventional vial product has limited differentiation.

What patent litigation or settlement agreements affect allopurinol sodium?

No major current patent litigation or settlement structure is associated with the mature allopurinol sodium injection market. The product does not have the litigation profile seen with high-value branded therapies, complex formulations, long-acting injectables, or biologics.

A new dispute would more likely involve:

• ANDA approval timing.
• Manufacturing quality.
• Labeling.
• Product liability.
• Supply contracts.
• Trademark or trade-dress issues.

Patent settlements are unlikely to have material market-wide relevance because no obvious remaining patent barrier controls generic entry.

What is the competitive outlook for allopurinol sodium?

The outlook is stable but low-growth. Demand should remain tied to inpatient oncology, acute hyperuricemia, and patients unable to receive oral therapy. The market has limited ability to expand through consumer promotion because treatment decisions occur in hospitals and clinical protocols.

Base-case commercial outlook

• Volume: Stable to modestly declining.
• Price: Competitive, with temporary increases during shortages.
• Margin: Moderate to pressured.
• Patent risk: Minimal.
• Regulatory risk: Concentrated in manufacturing and supply compliance.
• Market concentration: Potentially high if suppliers exit.
• Investment profile: Defensive niche product, not a growth asset.

A supplier with dependable sterile capacity can maintain a profitable position despite low unit demand. A supplier without scale may find the market unattractive because hospital contracts compress prices and quality requirements raise fixed costs.

Key Takeaways

• Allopurinol sodium is an injectable small-molecule formulation of allopurinol used mainly in hospital and oncology settings.
• The U.S. market is mature, genericized, and largely free of meaningful patent exclusivity.
• Orange Book and FDA listing status matter at the manufacturer and product level, not through a current branded patent strategy.
• Paragraph IV litigation, biosimilar competition, and patent settlements are not major current market drivers.
• Sterile manufacturing capacity, hospital contracting, and shortage conditions determine competitive performance.
• Public companies generally do not disclose allopurinol sodium revenue separately.
• Financial performance is likely stable but low growth, with episodic upside during supply disruptions.
• The principal commercial risk is additional generic competition; the principal supply risk is manufacturer exit or sterile-production interruption.

FAQs

Is allopurinol sodium the same as oral allopurinol?

It contains the same active moiety, but allopurinol sodium is an injectable formulation used when oral administration is not suitable.

Is allopurinol sodium still commercially available in the United States?

Availability depends on manufacturer listings, distributor inventory, and FDA shortage conditions. Products may be listed even when particular presentations are temporarily unavailable.

Does allopurinol sodium have biosimilar competition?

No. Biosimilars apply to biologic products. Allopurinol sodium is regulated as a small-molecule generic drug.

Can a new company launch generic allopurinol sodium without a patent license?

Generally, an applicant can pursue an ANDA without a license to expired patents, subject to FDA approval, applicable certifications, manufacturing compliance, and any currently listed enforceable rights.

Why can an old injectable drug remain commercially relevant?

Hospitals require reliable access to certain injectable medicines even when volumes are low. Sterile manufacturing constraints and supplier exits can preserve commercial value after patent expiry.

References

1. U.S. Food and Drug Administration. (n.d.). Allopurinol sodium injection prescribing information. FDA labeling database.

2. National Library of Medicine. (n.d.). DailyMed: Allopurinol sodium injection. U.S. National Library of Medicine.

3. U.S. Food and Drug Administration. (n.d.). Drug shortages. FDA.

4. U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA.

5. Hikma Pharmaceuticals PLC. (2024). Annual report and accounts 2023. Hikma Pharmaceuticals.