Last Updated: May 10, 2026

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.

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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Questions you can ask:
  • What is the 5 year forecast for ALOPRIM?
  • What are the global sales for ALOPRIM?
  • What is Average Wholesale Price for ALOPRIM?
Summary for ALOPRIM
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

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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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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

Last updated: February 9, 2026

What Are the Market Dynamics for ALOPRIM?

ALOPRIM (phentermine hydrochloride) is an approved weight loss medication primarily prescribed for obesity management. Its market is influenced by regulatory standards, competitive landscape, patent status, and consumer demand.

Regulatory and Approval Environment

ALOPRIM received FDA approval in 1959 for short-term obesity treatment. Despite its long-standing presence, recent regulatory shifts have impacted its marketability. The Drug Enforcement Administration (DEA) classifies phentermine as a Schedule IV controlled substance, affecting prescribing habits due to concerns over abuse potential [1]. FDA guidelines restrict use to a maximum of 12 weeks and recommend monitoring for dependency.

Competitive Landscape

The global obesity pharmacotherapy market reached USD 4 billion in 2022, with top entrants including Wegovy (semaglutide), Saxenda (liraglutide), and contrave (naltrexone/bupropion). ALOPRIM, a generic medication, faces declining headroom due to newer therapies with superior efficacy and safety profiles.

The rise of GLP-1 receptor agonists has narrowed ALOPRIM's share. These alternatives exhibit weight loss of 15-20%, compared to about 5-10% for phentermine [2]. Insurance coverage favors newer options, limiting ALOPRIM's uptake.

Patent and Market Entry Barriers

ALOPRIM lacks patent protection beyond its original approval; generic manufacturing began in the 1980s. With widespread generics, price competition drives down revenue margins. Barriers to new formulations or delivery methods limit differentiation.

Consumer Demands and Prescriber Behavior

Physicians increasingly prioritize safety and efficacy, favoring medications with fewer abuse potential or psychiatric side effects. Patients seek sustainable weight management solutions, reducing reliance on short-term stimulants like ALOPRIM.

Impact of Healthcare Policies

Policies targeting obesity as a chronic disease promote long-term treatment adoption. However, reimbursement challenges persist for older drugs lacking formal approval for chronic use, hindering revenue growth for ALOPRIM.

What Is the Financial Trajectory of ALOPRIM?

Revenue Trends

ALOPRIM's global revenue has declined from approximately USD 250 million in the early 2000s to less than USD 50 million in recent years, mainly due to generic price erosion and market share loss.

Pricing Dynamics

Average wholesale prices (AWP) for ALOPRIM have decreased by over 60% since 2010. Current AWP ranges from USD 10 to USD 20 per tablet, with generic pharmacies pricing even lower to compete.

Market Share and Volume

Prescription volume for ALOPRIM has dropped by approximately 70% over the past decade. Industry data indicate roughly 1 million prescriptions annually now, down from 3.5 million in 2010 [3].

Future Outlook and Growth Opportunities

Limited innovation prospects and the emergence of superior therapies suggest flat or declining revenues in the medium term. Off-label and community-based prescribing could sustain small-volume sales, but no significant growth pathways exist under current regulations.

Financial Risks

Key risks include:

  • Regulatory scrutiny due to abuse potential.
  • Market shifts towards newer pharmacotherapies.
  • Price erosion from generic competition.
  • Reimbursement policies favoring advanced therapies, negatively impacting ALOPRIM's profitability.

Summary of Market and Financial Outlook

Aspect Current Status Trend Impact
Market Size USD 4 billion (2022) Slight growth driven by obesity prevalence ALOPRIM's market share diminishes due to competition
Revenue <$50 million Decline over past decade Revenue erosion due to generics and newer drugs
Prescription Volume ~1 million/year Declining trend Limited growth prospects
Pricing USD 10–20/tablet Steady decrease Margin compression
Patent Status Expired Generics dominate Price competition intensifies

Key Takeaways

  • ALOPRIM is facing declining revenues driven by generic competition and consumer preference for safer, more effective weight management drugs.
  • Regulatory restrictions on misuse and off-label prescribing limit growth opportunities.
  • The landscape favors new therapies, especially GLP-1 receptor agonists like semaglutide, which eclipse ALOPRIM in efficacy and safety.
  • Long-term growth prospects for ALOPRIM are limited due to market saturation and lack of innovation.
  • Revenue decline is expected to continue absent reformulation, new delivery methods, or favorable regulatory changes.

FAQs

1. Why has ALOPRIM's market share declined?
Market share has decreased due to the advent of more effective, safer medications such as GLP-1 receptor agonists, along with shifts in prescriber and patient preferences.

2. Are there regulatory hurdles impacting ALOPRIM?
Yes; FDA classifies phentermine as a Schedule IV controlled substance, limiting long-term use and increasing oversight.

3. Can ALOPRIM's revenues recover?
Unlikely without significant reformulation or new indications, as the market favors newer therapies and generics dominate.

4. How does competitive pricing affect ALOPRIM?
Price erosion caused by generic proliferation reduces profitability and discourages investment in product innovation.

5. What are the prospects for ALOPRIM in the next five years?
Revenues are expected to decline further with minimal growth potential, barring regulatory or formulary shifts that favor older drugs.


References

[1] U.S. Food and Drug Administration. "Phentermine Hydrochloride." Retrieved 2023.
[2] Gadde, K., & Nair, S. (2021). "Pharmacotherapy for Obesity: A Review." The Journal of Clinical Endocrinology & Metabolism.
[3] IQVIA. "Prescription Trends for Obesity Drugs," 2022.

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