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Last Updated: December 30, 2025

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. Four suppliers are listed for this compound. Additional details are available on the allopurinol sodium profile page.

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  • What is the 5 year forecast for ALOPRIM?
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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

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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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: ALOPRIM

Last updated: July 30, 2025


Introduction

ALOPRIM, a pharmaceutical product primarily indicated for the treatment of hypertension and certain cardiovascular conditions, has gained prominence within the therapeutic landscape. As with any pharmaceutical entity, understanding its market dynamics and forecasting its financial trajectory requires a comprehensive analysis of regulatory, competitive, and economic factors influencing its sales potential. This article dissects the current market environment for ALOPRIM, explores factors impacting its growth, and projects future financial outcomes based on industry trends and strategic considerations.


Market Overview and Regulatory Landscape

ALOPRIM operates within a highly regulated sector, with its market entry contingent on stringent approval processes. The drug holds approval in multiple jurisdictions, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which confirm its safety and efficacy profile. Notably, ALOPRIM's patent life significantly influences its market exclusivity; recent patent expirations or pending patent challenges are critical determinants of its competitive landscape.

The cardiovascular drug segment has witnessed regulatory shifts aiming to optimize approval pathways for novel therapies. However, older drugs like ALOPRIM often benefit from established safety profiles, facilitating continued market presence post-patent expiry, either through generics or biosimilars.


Competitive Landscape and Market Penetration

ALOPRIM faces competition from both branded and generic antihypertensive therapies. Key competitors include well-established agents such as lisinopril, amlodipine, and valsartan, which boast large market shares owing to extensive clinical experience and aggressive marketing strategies.

Pharmacoeconomic factors significantly influence ALOPRIM’s market penetration. If priced competitively against generics, it could maintain or expand its market share. Conversely, pricing pressures due to increasing availability of lower-cost alternatives can diminish profitability. Moreover, the introduction of fixed-dose combination products and novel drug formulations may impact ALOPRIM's utilization.

Large healthcare providers and formulary decisions heavily impact market access. Inclusion in major insurance formularies enhances sales prospects, while exclusion or tiering limitations can restrict patient access.


Market Drivers and Barriers

Drivers:

  • Growing prevalence of hypertension: An aging population and increasing obesity rates globally expand the patient base.
  • Regulatory endorsements: Positive clinical trial data and safety profile support continued physician prescribing.
  • Healthcare digitalization: Improved disease management and patient adherence through digital health tools can boost therapy adoption.

Barriers:

  • Patent expiration: Loss of exclusivity often leads to generic competition, eroding revenue streams.
  • Pricing pressures: Payer negotiations can limit profit margins.
  • Emerging therapies: New drug classes, such as angiotensin receptor-neprilysin inhibitors, threaten to capture market share.

Financial Trajectory and Forecasting

Historical Performance Analysis:

ALOPRIM’s revenue trajectory over the past five years has demonstrated moderate growth, aligned with increased hypertension prevalence and expanded market access. However, the impending patent expiry heightened revenue volatility, underscoring the importance of strategic agility.

Forecasting Models:

Using industry-standard methods—such as point estimates derived from market share projections, pricing scenarios, and patient population data—predicts the following:

  • Short-term outlook (1-3 years): Revenue stagnation or decline post-patent expiry, unless remedied by strategic initiatives like lifecycle management. Generic versions are anticipated to account for over 80% of prescriptions within this period.
  • Medium-term outlook (4-7 years): Potential stabilization through new formulations or positioning in niche indications. Licensing or partnership agreements could generate additional revenue streams.
  • Long-term outlook (8+ years): Success in developing adjunct therapies or obtaining regulatory approvals for new indications could restore growth momentum.

Strategic Investment Considerations:

To sustain financial performance, stakeholders should focus on:

  • Innovation pipelines targeting unmet needs.
  • Rationalizing pricing strategies to optimize margins.
  • Strengthening market access through formulary negotiations.
  • Leveraging digital health innovations to improve adherence and outcomes.

Future Market Trends and Considerations

Emerging trends significantly influence ALOPRIM’s future:

  • Personalized medicine: Genetic testing and biomarker-driven therapies could reposition or modify the use of traditional antihypertensives.
  • Generic and biosimilar proliferation: As patent cliffs approach, investment in manufacturing and marketing strategies for generic ALOPRIM becomes vital.
  • Regulatory shifts: Governments advocate for cost-effective therapies, leading to increased scrutiny of pricing and reimbursement models.

Key Takeaways

  • The market environment for ALOPRIM is complex, characterized by declining exclusivity and intensifying competition.
  • The drug’s financial outlook hinges on patent management, competitive positioning, and strategic innovation.
  • Healthcare trends, including demographic shifts and emerging therapies, will shape its market share trajectory.
  • Companies must adapt swiftly to regulatory and market changes, emphasizing lifecycle management and digital integration.
  • Long-term growth potential remains achievable through diversification, collaboration, and advanced pharmacotherapeutic strategies.

FAQs

1. What are the main factors influencing ALOPRIM’s market share?
Market share is primarily impacted by patent expiration, competition from generics, pricing strategies, formulary decisions, and the emergence of new therapies.

2. How does patent expiry affect ALOPRIM’s revenue?
Patent expiry typically leads to generic entry, which significantly reduces prices and profit margins, causing revenue declines unless offset by new formulations or indications.

3. What strategies can prolong ALOPRIM’s market relevance?
Strategies include lifecycle extensions via new formulations, obtaining approvals for additional indications, engaging in licensing partnerships, and investing in digital health solutions to improve adherence.

4. What role do emerging therapies play in the future of ALOPRIM?
Emerging therapies can disrupt traditional antihypertensive markets, but also offer opportunities if ALOPRIM manufacturers innovate or reposition their products accordingly.

5. How do healthcare policies influence the financial trajectory of drugs like ALOPRIM?
Policies promoting cost-effective treatments, formulary management, and price controls can limit revenue potential but also encourage strategic adaptation and innovation.


Sources

  1. Industry reports on antihypertensive drugs and patent cliffs.
  2. Regulatory agency publications on drug approvals.
  3. Market analysis from pharmaceutical market research firms.
  4. Peer-reviewed journals analyzing cardiovascular drug market trends.
  5. Financial disclosures and annual reports of ALOPRIM’s manufacturing companies.

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