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, Chartwell, Endo Operations, Harman Finochem, Hetero Labs Ltd V, Indoco, Ipca Labs Ltd, Lupin Ltd, Mutual Pharm, Mylan, Northstar Hlthcare, Puracap Pharm, Purepac Pharm, Sandoz, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Unichem, Watson Labs, Zydus Pharms, Abbott, Dr Reddys, Casper Pharma Llc, Gland Pharma Ltd, Hikma, and Ironwood Pharms Inc, and is included in thirty-six NDAs. There are nine 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 suppliers are listed for this compound.

Summary for allopurinol

US Patents:	9
Tradenames:	6
Applicants:	27
NDAs:	36
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	274
Clinical Trials:	222
Patent Applications:	7,833
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
Urica Therapeutics Inc.	Phase 1/Phase 2
Dana-Farber Cancer Institute	Phase 2
Eli Lilly and Company	Phase 2

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
Ironwood Pharms Inc	DUZALLO	allopurinol; lesinurad	TABLET;ORAL	209203-002	Aug 18, 2017		DISCN	Yes	No
Sun Pharm Inds Inc	ALLOPURINOL	allopurinol	TABLET;ORAL	078390-001	Aug 30, 2007		DISCN	No	No
Unichem	ALLOPURINOL	allopurinol	TABLET;ORAL	211820-002	Mar 12, 2019	AB	RX	No	Yes
Mutual Pharm	ALLOPURINOL	allopurinol	TABLET;ORAL	070467-001	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
Casper Pharma Llc	ZYLOPRIM	allopurinol	TABLET;ORAL	016084-002	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	016084-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Allopurinol

Introduction to Allopurinol

Allopurinol is a prescription medication used to treat high levels of uric acid in the body, which can lead to conditions such as gout and kidney stones. It is also utilized to manage uric acid levels in patients undergoing cancer treatment. Available in both oral tablet and intravenous forms, allopurinol is a xanthine oxidase inhibitor that reduces uric acid synthesis in the body[1][4].

Market Growth and Forecast

The global allopurinol market is anticipated to experience significant growth over the forecast period of 2022-2029. According to Data Bridge Market Research, the market is expected to grow at a Compound Annual Growth Rate (CAGR) of 6% during this period. This growth is driven by several key factors, including the increasing incidence of gout and kidney stones, a rising geriatric population, and growing healthcare expenditure[1].

Key Drivers of Market Growth

• Increasing Incidence of Gout and Kidney Stones: The rise in the number of people suffering from gout and kidney stones is a major driver for the expansion of the allopurinol market. These conditions are becoming more prevalent due to factors such as obesity, unhealthy lifestyle, and increasing alcohol consumption[1][4].
• Rising Geriatric Population: The growing elderly population is another significant factor, as older adults are more prone to developing gout and other uric acid-related disorders.
• Growing Healthcare Expenditure: Increased healthcare spending and better healthcare infrastructure, particularly in regions like North America, are also contributing to market growth[1][4].

Market Segmentation

The allopurinol market is segmented based on several criteria, including:

• Drug Class: Antigout agents and antihyperuricemic agents.
• Application: Gout, kidney stones, and other conditions.
• Demographic: Adult and pediatric populations.
• Dosage Form: Intravenous powder for injection and oral tablets.
• End-Users: Clinics, hospitals, and other healthcare facilities.
• Distribution Channel: Hospital pharmacy, retail pharmacy, and online pharmacy[1].

Geographical Analysis

• North America: This region dominates the allopurinol market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure. North America accounted for the largest market share in 2020 and is expected to continue its dominance[1][4].
• Asia-Pacific: This region is expected to grow significantly during the forecast period due to increasing research and development activities and growing government support. The rise in gout incidences, driven by factors like increasing alcohol consumption and unhealthy lifestyles, is also a key factor in this region[1][4].

Financial Considerations and Cost Analysis

The cost of allopurinol can vary based on several factors, including treatment plan, insurance coverage, and the pharmacy used.

• Cost Without Insurance: The price of allopurinol without insurance is typically higher. Factors affecting the cost include the quantity prescribed, dosage, and pharmacy used[2].
• Generic vs. Brand Name: Allopurinol is available as both generic and brand-name drugs (Zyloprim, Lopurin, and Aloprim). Generic versions are generally cheaper and considered as safe and effective as the brand-name counterparts[2].
• Savings Options: Patients can save money by using coupons, getting a 90-day supply, or using mail-order pharmacies. Financial assistance programs and savings cards are also available to help reduce costs[2].

Challenges and Restraints

Despite the positive growth outlook, the allopurinol market faces several challenges:

• High Cost of the Drug: The high cost of allopurinol, especially for those without insurance, can be a significant barrier.
• Side Effects: Allopurinol is associated with various side effects such as loss of appetite, dizziness, fever, chills, blood in urine, and skin rash, which can hamper market growth.
• Lack of Awareness: Limited awareness about the drug and its benefits in certain regions can also pose a challenge[1].

Competitive Landscape

The global allopurinol market is competitive, with several key players operating in the space. These include:

• 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
• Accord Healthcare Ltd.[4].

Emerging Opportunities

• Research and Development: Increasing research and development activities, particularly in emerging markets, provide beneficial opportunities for the allopurinol market.
• New Markets: The emergence of new markets and growing government support in regions like Asia-Pacific are expected to drive market growth[1][4].

Impact of COVID-19

The COVID-19 pandemic had a short-term impact on the allopurinol market due to lockdowns, travel restrictions, and supply chain disruptions. However, the market is expected to recover and continue its growth trajectory as these disruptions are mitigated[4].

Comparison with Other Treatments

Allopurinol is often compared with other treatments for hyperuricaemia, such as febuxostat. Febuxostat has been shown to be more effective than allopurinol in reducing serum urate levels, especially in patients with impaired renal function. However, febuxostat also comes with its own set of side effects and considerations[5].

Key Takeaways

• The global allopurinol market is expected to grow at a CAGR of 6% from 2022 to 2029.
• Key drivers include the increasing incidence of gout and kidney stones, a rising geriatric population, and growing healthcare expenditure.
• North America dominates the market, but Asia-Pacific is expected to grow significantly.
• The cost of allopurinol varies based on insurance, dosage, and pharmacy used.
• Challenges include high drug costs, side effects, and lack of awareness.
• Emerging opportunities lie in research and development and new market emergence.

Frequently Asked Questions (FAQs)

What is the primary use of allopurinol?

Allopurinol is primarily used to treat high levels of uric acid in the body, which can lead to conditions such as gout and kidney stones. It is also used to manage uric acid levels in patients undergoing cancer treatment[1][4].

How does the cost of allopurinol vary?

The cost of allopurinol can vary based on several factors, including treatment plan, insurance coverage, dosage, and the pharmacy used. Generic versions are generally cheaper than brand-name drugs[2].

What are the common side effects of allopurinol?

Common side effects of allopurinol include loss of appetite, dizziness, fever, chills, blood in urine, and skin rash[1].

Which regions are expected to drive the growth of the allopurinol market?

North America currently dominates the allopurinol market, but the Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and growing government support[1][4].

How does allopurinol compare with other treatments like febuxostat?

Allopurinol is often compared with febuxostat, which has been shown to be more effective in reducing serum urate levels, especially in patients with impaired renal function. However, febuxostat also has its own set of side effects and considerations[5].

Cited Sources:

1. Data Bridge Market Research. Global Allopurinol Market - Industry Trends and Forecast to 2029.
2. Medical News Today. Allopurinol cost 2024: Savings tips and more.
3. News Channel Nebraska. Gout Drugs Market Growth to Attain 14.79% by 2032.
4. Stratview Research. Allopurinol Tablets Market | Market Size, Share & Forecast Analysis.
5. Rheumatology. Febuxostat: a new treatment for hyperuricaemia in gout.