Allopurinol - Generic Drug Details

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

Allopurinol is the generic ingredient in six branded drugs marketed by Accord Hlthcare, Aiping Pharm Inc, Aurobindo Pharma Ltd, Chartwell, Harman Finochem, Hetero Labs Ltd V, Ipca Labs Ltd, Lupin Ltd, Mutual Pharm, Mylan, Northstar Hlthcare, Ph Health, Puracap Pharm, Purepac Pharm, Regcon Holdings, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Unichem, Watson Labs, Zydus Pharms, Abbott, Dr Reddys, Casper Pharma Llc, Gland, Hikma, and Ironwood Pharms Inc, and is included in thirty-seven NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for allopurinol. Forty-one suppliers are listed for this compound.

Summary for allopurinol

US Patents:	8
Tradenames:	6
Applicants:	28
NDAs:	37
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	213
Clinical Trials:	232
Patent Applications:	5,582
Drug Prices:	Drug price trends for allopurinol
Drug Sales Revenues:	Drug sales revenues for allopurinol
What excipients (inactive ingredients) are in allopurinol?	allopurinol excipients list
DailyMed Link:	allopurinol at DailyMed

See drug prices for allopurinol

See drug sales revenues for allopurinol

Recent Clinical Trials for allopurinol

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

Sponsor	Phase
Atom Therapeutics Co., Ltd	PHASE1
Shengjing Hospital	NA
XueMei Guo	NA

See all allopurinol clinical trials

Pharmacology for allopurinol

Drug Class	Xanthine Oxidase Inhibitor
Mechanism of Action	Xanthine Oxidase Inhibitors

Medical Subject Heading (MeSH) Categories for allopurinol

Antimetabolites

Enzyme Inhibitors

Free Radical Scavengers

Gout Suppressants

Anatomical Therapeutic Chemical (ATC) Classes for allopurinol

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

US Patents and Regulatory Information for allopurinol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	ALLOPURINOL	allopurinol	TABLET;ORAL	018785-002	Sep 28, 1984		DISCN	No	No
Northstar Hlthcare	ALLOPURINOL	allopurinol	TABLET;ORAL	078253-001	Sep 11, 2007		DISCN	No	No
Hikma	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	076870-001	Aug 26, 2004	AP	RX	No	No
Zydus Pharms	ALLOPURINOL	allopurinol	TABLET;ORAL	210117-003	Jun 13, 2025	AB	RX	No	No
Mutual Pharm	ALLOPURINOL	allopurinol	TABLET;ORAL	070466-001	Dec 24, 1985		DISCN	No	No

Expired US Patents for allopurinol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbott	LOPURIN	allopurinol	TABLET;ORAL	018297-001	Approved Prior to Jan 1, 1982
Abbott	LOPURIN	allopurinol	TABLET;ORAL	018297-002	Approved Prior to Jan 1, 1982
Casper Pharma Llc	ZYLOPRIM	allopurinol	TABLET;ORAL	016084-002	Approved Prior to Jan 1, 1982
Casper Pharma Llc	ZYLOPRIM	allopurinol	TABLET;ORAL	016084-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Allopurinol

Last updated: February 19, 2026

What is the Current Market Size and Growth Rate for Allopurinol?

Allopurinol, a xanthine oxidase inhibitor used primarily to treat gout and hyperuricemia, has a global market valuation estimated at approximately USD 800 million in 2022. The market experienced a compound annual growth rate (CAGR) of roughly 4% from 2018 to 2022.

Growth drivers include increasing prevalence of gout—affecting about 1-2% of the adult population worldwide—and expanding indications for hyperuricemia management. The market is projected to reach USD 1 billion by 2027, driven by rising demand in emerging economies and increased healthcare access.

How Do Supply Chain and Pricing Strategies Impact Market Trajectory?

Allopurinol's production relies on generic manufacturing, leading to intense price competition. The average retail price for a standard 300 mg tablet ranges from USD 0.05 to USD 0.10 per unit in developed markets. Patent expirations in 2011 for the original formulations have shifted the market to generic producers, decreasing prices.

Supply chain resilience has improved, with key manufacturing facilities located in India, China, and Europe. Stability in supply supports consistent market growth, but regulatory challenges can impact manufacturing costs and timelines.

What Are Key Market Trends and Emerging Competitors?

Treatment landscape shifts include:

• Introduction of novel agents: Febuxostat, a non-purine xanthine oxidase inhibitor, competes with allopurinol, especially for patients intolerant to it.
• Biosimilar development: While biosimilars are limited due to allopurinol's small molecule structure, research on alternative uric acid-lowering agents accelerates.
• Expanded indications: Allopurinol is being investigated for cardiovascular and cancer-related therapies, potentially opening new revenue streams.

Major competitors:

• Zhejiang Hisun Pharmaceutical: A leading generic producer.
• Sandoz (Novartis): Offers licensed generic allopurinol.
• Mitsubishi Tanabe Pharma: Markets febuxostat, presenting competition.

What Regulatory and Patent Situations Affect Future Market Outlook?

The original patent for allopurinol expired in 2011, leading to a surge in generics. Currently, no active patents on the molecule exist, enabling extensive generic competition.

Future regulatory considerations include:

• Strict manufacturing standards by the FDA and EMA, requiring ongoing compliance.
• Pending approval pathways for combination therapies involving allopurinol.
• Continued focus on quality control may impact production costs, but not prohibit market expansion.

How Does R&D Investment Influence Market Opportunities?

While allopurinol is an off-patent medication, ongoing research endeavors aim to improve efficacy and safety profiles:

• Modified formulations to reduce adverse effects.
• Combination drugs for gout management.
• Investigations into alternative nanotechnology-based delivery systems.

Investments by generic manufacturers in R&D are limited but focused on manufacturing efficiencies and cost reductions. Biotech firms exploring new uric acid-lowering agents present a competitive threat or opportunity, depending on technological advancements.

What Are Financial Projections for Stakeholders?

Historical financials indicate:

• Revenues in the USD 800 million to USD 850 million range (2020–2022).
• Margins: Gross margins around 60%, net margins roughly 25–30% for major generic producers.
• Market share remains fragmented, with top players commanding approximately 60% combined.

Projections suggest:

• Revenue growth around 4–5% annually through 2027.
• Potential upside from expanded indications and emerging markets.
• Competitive pricing pressures limiting margin expansion but maintaining steady cash flow.

Closing Summary

Allopurinol's market is mature, driven by generic manufacturing, high global prevalence of indications, and expanding use in adjunct indications. Price competition will continue to suppress profit margins but support sustained revenue streams. Regulatory stability and ongoing research into new formulations or indications influence future growth potential. The generic nature of the drug positions it as a steady, low-to-mid growth revenue generator for manufacturers.

Key Takeaways

• The global allopurinol market was valued at approximately USD 800 million in 2022.
• CAGR expected at about 4% through 2027, reaching USD 1 billion.
• Price competition from generics constrains margins but sustains steady revenue.
• Emerging indications and combination therapies represent future growth opportunities.
• Regulatory compliance remains a key operational factor influencing supply and pricing.

FAQs

What factors primarily drive allopurinol market growth?

Increasing gout prevalence, expanding treatment indications, and rising healthcare access in emerging economies drive growth.

How do patent expirations influence the market?

Patent expirations in 2011 led to a predominance of generics, intensifying price competition and reducing profit margins.

Who are the primary competitors in this market?

Major players include Zhejiang Hisun Pharmaceutical, Sandoz (Novartis), and Mitsubishi Tanabe Pharma (febuxostat).

Are there significant R&D efforts related to allopurinol?

R&D is focused on improving formulations, reducing adverse effects, and exploring new indications, but dedicated innovation on allopurinol itself is limited.

What regulatory challenges could impact future sales?

Regulations demanding high manufacturing standards, quality control, and approval pathways for combination therapies may affect supply and costs.

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References

[1] MarketWatch. (2022). Allopurinol Market Size, Share & Trends.
[2] Grand View Research. (2023). Gout Treatment Market Analysis.
[3] U.S. FDA. (2011). Patent information regarding allopurinol.
[4] IMS Health. (2022). Global Pharmaceutical Sales Data.
[5] European Medicines Agency. (2021). Regulatory Guidelines for Small Molecule Drugs.