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Last Updated: December 22, 2024

ALOPRIM Drug Patent Profile


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When do Aloprim patents expire, and when can generic versions of Aloprim launch?

Aloprim is a drug marketed by Mylan and is included in one NDA.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Aloprim

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

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Summary for ALOPRIM
Drug patent expirations by year for ALOPRIM
Drug Prices for ALOPRIM

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Recent Clinical Trials for ALOPRIM

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

SponsorPhase
Washington University School of MedicinePhase 1/Phase 2
Open Medicine InstitutePhase 4
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Phase 4

See all ALOPRIM clinical trials

Pharmacology for ALOPRIM

US Patents and Regulatory Information for ALOPRIM

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan ALOPRIM allopurinol sodium INJECTABLE;INJECTION 020298-001 May 17, 1996 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ALOPRIM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Allopurinol (Zyloprim, Lopurin)

Introduction

Allopurinol, marketed under brand names such as Zyloprim and Lopurin, is a prescription medication used to treat conditions like gout, kidney stones, and high uric acid levels, particularly in patients undergoing cancer treatment. Here, we delve into the market dynamics and financial trajectory of allopurinol.

Market Growth Drivers

The allopurinol market is driven by several key factors:

Increasing Incidence of Gout and Kidney Stones

The rise in the incidence of gout and kidney stones globally is a significant driver for the allopurinol market. These conditions are becoming more prevalent, especially among older populations, due to lifestyle factors such as sedentary lifestyles and diets high in purines[1][4].

Growing Geriatric Population

The increasing geriatric population is another crucial factor. Older adults are more prone to gout and other conditions that require urate-lowering therapy, thereby increasing the demand for allopurinol[1][4].

Rising Healthcare Expenditure

Increased healthcare expenditure and the growing demand from various end-use industries, such as hospitals and clinics, also contribute to the market growth. The well-developed healthcare infrastructure in regions like North America further supports this trend[1].

Regulatory Approvals and Generic Formulations

Regulatory approvals for generic formulations of allopurinol have made the drug more affordable and accessible, driving market growth. The affordability of allopurinol tablets ensures that patients with hyperuricemia can access crucial urate-lowering medicines[4].

Market Size and Projections

The allopurinol market is substantial and growing:

Current Market Size

As of 2023, the allopurinol tablets market was valued at USD 1.18 billion[4].

Future Projections

The market is expected to reach USD 1.97 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 6.72% from 2024 to 2031. This growth is driven by the increasing demand for effective urate-lowering therapies and the expanding geriatric population[4].

Geographical Distribution

The allopurinol market is geographically diverse:

North America

North America dominates the allopurinol market due to the presence of major key players, high disposable income, and well-developed healthcare infrastructure in this region[1].

Asia-Pacific

The Asia-Pacific region is expected to grow significantly during the forecast period due to increasing research and development activities and growing government support. Countries like China, Japan, and India are key contributors to this growth[1].

End-Users and Distribution Channels

The market is segmented based on end-users and distribution channels:

End-Users

The primary end-users include clinics, hospitals, and other healthcare facilities. These institutions drive the demand for allopurinol due to its widespread use in treating gout and kidney stones[1].

Distribution Channels

The drug is distributed through various channels, including hospital pharmacies, retail pharmacies, and online pharmacies. The convenience and accessibility offered by these channels contribute to the market's growth[1].

Challenges and Limitations

Despite the positive market dynamics, there are several challenges:

High Cost and Side Effects

The high cost of the drug and associated side effects, such as loss of appetite, dizziness, fever, chills, blood in urine, and skin rash, can hamper market growth. These side effects can deter some patients from using allopurinol, despite its efficacy[1].

Lack of Awareness

Lack of awareness about the benefits and proper use of allopurinol can also challenge market growth. Educating both healthcare providers and patients is crucial to overcoming this barrier[1].

Regulatory Environment

The regulatory environment plays a significant role in the allopurinol market:

FDA Approvals and Safety Concerns

While the FDA has approved allopurinol, there are concerns about the expedited approval process for some drugs, which can lead to safety issues. For instance, the FDA's approval of drugs like Uloric and Nuplazid has been criticized due to their side effects and limited efficacy[3].

Compliance and Guidelines

Pharmaceutical companies must comply with strict guidelines and regulations to ensure the safe and effective use of drugs like allopurinol. Non-compliance can result in significant penalties, as seen in cases like GSK's settlement with the U.S. Department of Justice[5].

Competitive Landscape

The pharmaceutical industry is highly competitive, and companies like GSK, which have a strong presence in the market, influence the dynamics:

Major Players

Companies such as GSK, with their extensive research and development capabilities and global reach, play a significant role in the allopurinol market. These companies often acquire smaller firms and expand their product portfolios to maintain market dominance[5].

Generic Competition

The availability of generic formulations of allopurinol also affects the competitive landscape. Generic drugs offer a more affordable alternative, which can impact the sales of branded versions[4].

Financial Performance

The financial performance of the allopurinol market is robust:

Revenue Growth

The market is expected to see significant revenue growth, driven by the increasing demand for allopurinol tablets. The projected CAGR of 6.72% from 2024 to 2031 indicates a strong financial trajectory[4].

Profitability

The profitability of pharmaceutical companies involved in the allopurinol market is sustained by improved gross margins and operational efficiencies. For example, companies like Aurobindo Pharma have reported significant net profit increases due to strong sales across various business segments[2].

Key Takeaways

  • The allopurinol market is driven by the increasing incidence of gout and kidney stones, a growing geriatric population, and rising healthcare expenditure.
  • The market is expected to grow at a CAGR of 6.72% from 2024 to 2031, reaching USD 1.97 billion by 2031.
  • North America and the Asia-Pacific region are key markets due to their well-developed healthcare infrastructure and growing government support.
  • High drug costs and side effects, along with lack of awareness, are significant challenges.
  • The regulatory environment and competitive landscape, including major players and generic competition, influence market dynamics.

FAQs

Q: What are the primary uses of allopurinol? A: Allopurinol is primarily used to treat gout, kidney stones, and to lower uric acid levels in patients undergoing cancer treatment.

Q: What are the major drivers of the allopurinol market? A: The major drivers include the increasing incidence of gout and kidney stones, a growing geriatric population, and rising healthcare expenditure.

Q: Which regions dominate the allopurinol market? A: North America and the Asia-Pacific region are the dominant markets due to their well-developed healthcare infrastructure and growing government support.

Q: What are the challenges facing the allopurinol market? A: High drug costs, side effects, and lack of awareness are significant challenges to the market growth.

Q: How is the competitive landscape of the allopurinol market? A: The market is highly competitive with major players like GSK and significant generic competition, which affects the sales of branded versions.

Sources

  1. Data Bridge Market Research - Global Allopurinol Market - Industry Trends and Forecast to 2029
  2. Business Standard - Aurobindo Pharma on Saturday said its consolidated net profit increased 61 per cent year on year
  3. ProPublica - FDA Repays Industry by Rushing Risky Drugs to Market
  4. Market Research Intellect - Global Allopurinol Tablets Market Size and Projections
  5. Wikipedia - GSK plc

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