ALLOPURINOL SODIUM - Generic Drug Details

What are the generic drug sources for allopurinol sodium and what is the scope of freedom to operate?

Allopurinol sodium is the generic ingredient in two branded drugs marketed by Gland Pharma Ltd, Hikma, and Mylan, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for ALLOPURINOL SODIUM

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	10
Patent Applications:	28
What excipients (inactive ingredients) are in ALLOPURINOL SODIUM?	ALLOPURINOL SODIUM excipients list
DailyMed Link:	ALLOPURINOL SODIUM at DailyMed

Recent Clinical Trials for ALLOPURINOL SODIUM

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

Sponsor	Phase
University of Bari	Phase 4
Fondazione Schena	Phase 4
University of Colorado Denver School of Medicine Barbara Davis Center	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 Pharma Ltd	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	212363-001	Jan 26, 2022	AP	RX	No	No
Mylan	ALOPRIM	allopurinol sodium	INJECTABLE;INJECTION	020298-001	May 17, 1996	AP	RX	Yes	Yes
Hikma	ALLOPURINOL SODIUM	allopurinol sodium	INJECTABLE;INJECTION	076870-001	Aug 26, 2004	AP	RX	No	No

ALLOPURINOL SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Allopurinol Sodium

Introduction to Allopurinol Sodium

Allopurinol sodium is a medication used to decrease high blood uric acid levels, primarily to prevent gout and certain types of kidney stones. It belongs to the class of xanthine oxidase inhibitors, which block the formation of uric acid in the body[5].

Market Size and Growth Projections

The global allopurinol market, including allopurinol sodium, is expected to experience significant growth over the coming years. Here are some key projections:

• The allopurinol market is anticipated to grow at a CAGR of 6% from 2022 to 2029, driven by increasing incidences of gout and kidney stones globally[1].
• The allopurinol tablets market was valued at USD 1.18 billion in 2023 and is projected to reach USD 1.97 billion by 2031, growing at a CAGR of 6.72% from 2024 to 2031[3].

Market Drivers

Several factors are driving the growth of the allopurinol market:

• Increasing Incidence of Gout and Kidney Stones: The rising prevalence of gout and kidney stones, particularly in older populations and in regions with lifestyle factors such as high purine diets and sedentary lifestyles, is a major driver[3][4].
• Growing Geriatric Population: The increasing geriatric population, which is more prone to gout and other uric acid-related disorders, contributes to market growth[1].
• Rising Healthcare Expenditure: Increased healthcare spending and better healthcare infrastructure, especially in North America and Europe, support the demand for allopurinol[1].
• Research and Development: Advances in pharmaceutical production techniques and pharmacogenomics improve the efficacy and availability of allopurinol, further driving market growth[3].

Market Segmentation

The allopurinol market is segmented based on several criteria:

• Drug Class: Antigout agents and antihyperuricemic agents[1].
• Application: Gout, kidney stones, and other conditions such as hyperuricemia and certain malignancies[1][3][4].
• Demographic: Adult and pediatric populations[1].
• Dosage Form: Intravenous powder for injection and oral tablets[1].
• End-Users: Clinics, hospitals, and other healthcare facilities[1].
• Distribution Channel: Hospital pharmacy, retail pharmacy, and online pharmacy[1].
• Geographical Regions: North America, Europe, Asia-Pacific, South America, and Middle East and Africa[1][3][4].

Geographical Analysis

• North America: Dominates the allopurinol market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure[1][4].
• Asia-Pacific: Expected to grow significantly due to increasing research and development activities, growing government support, and rising incidence of gout and kidney stones driven by lifestyle changes[1][4].

Key Players and Competitive Landscape

The market is competitive with several key players:

• Casper Pharma, Teva Pharmaceutical Industries Ltd., Dr. Reddy's Laboratories, Mylan N.V., Apotex Inc., Sun Pharmaceutical Industries Limited, Zydus Pharmaceuticals Inc., NorthStar Healthcare, Ipca Laboratories Limited, and Accord Healthcare Ltd. are among the major players in the allopurinol tablets market[4].

Challenges and Limitations

Despite the growth potential, the allopurinol market faces several challenges:

• High Cost of the Drug: The cost of allopurinol can be a barrier, especially in regions with limited healthcare resources[1].
• Side Effects: Allopurinol is associated with side effects such as loss of appetite, dizziness, fever, chills, blood in urine, and skin rash, which can hamper market growth[1][2].
• Lack of Awareness: Limited awareness about the benefits and proper use of allopurinol in some regions can also pose a challenge[1].

Pharmacokinetics and Clinical Use

Allopurinol is rapidly metabolized to oxypurinol, which is the primary active metabolite responsible for its pharmacological effects. The drug is administered both orally and intravenously, with similar pharmacokinetic profiles for both routes of administration[2].

Regulatory and Market Dynamics

• Regulatory Approvals: Generic formulations of allopurinol have received regulatory approvals, making the drug more accessible and affordable, which is expected to boost market growth[3].
• Supply Chain and COVID-19 Impact: The COVID-19 pandemic caused temporary disruptions in the supply chain, affecting product availability and market growth. However, the market is expected to recover as supply chains normalize[4].

Financial Trajectory

The financial trajectory of the allopurinol market is positive, driven by increasing demand and expanding market segments:

• The market is expected to grow from USD 1.18 billion in 2023 to USD 1.97 billion by 2031, indicating a steady and significant increase in revenue[3].
• The CAGR of 6% to 6.72% over the forecast period suggests a robust financial outlook for the allopurinol market[1][3].

Key Takeaways

• The allopurinol market is driven by the increasing incidence of gout and kidney stones, a growing geriatric population, and advancements in pharmaceutical production.
• North America dominates the market, but Asia-Pacific is expected to grow significantly.
• Key players include major pharmaceutical companies, and the market faces challenges such as high drug costs and side effects.
• Regulatory approvals for generic formulations and improving healthcare infrastructure support market growth.

FAQs

Q: What is the primary use of allopurinol sodium? A: Allopurinol sodium is used to decrease high blood uric acid levels, primarily to prevent gout and certain types of kidney stones.

Q: What is the expected CAGR of the allopurinol market from 2022 to 2029? A: The allopurinol market is expected to grow at a CAGR of 6% from 2022 to 2029[1].

Q: Which region dominates the allopurinol market? A: North America dominates the allopurinol market due to the presence of major key players and well-developed healthcare infrastructure[1][4].

Q: What are the major side effects associated with allopurinol? A: Side effects include loss of appetite, dizziness, fever, chills, blood in urine, and skin rash[1][2].

Q: How does the COVID-19 pandemic affect the allopurinol market? A: The pandemic caused temporary supply chain disruptions, but the market is expected to recover as supply chains normalize[4].

Cited Sources

1. Data Bridge Market Research: Global Allopurinol Market - Industry Trends and Forecast to 2029.
2. FDA: ALOPRIM® (allopurinol sodium) for Injection 500 mg.
3. Market Research Intellect: Global Allopurinol Tablets Market Size and Projections.
4. Stratview Research: Allopurinol Tablets Market | Market Size, Share & Forecast Analysis.
5. Wikipedia: Allopurinol.