Last Updated: July 15, 2026

BONTRIL Drug Patent Profile


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Which patents cover Bontril, and when can generic versions of Bontril launch?

Bontril is a drug marketed by Valeant and Bausch and is included in two NDAs.

The generic ingredient in BONTRIL is phendimetrazine tartrate. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.

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

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

SponsorPhase
University of KentuckyPhase 1
National Institute on Drug Abuse (NIDA)Phase 1
William StoopsPhase 1

See all BONTRIL clinical trials

US Patents and Regulatory Information for BONTRIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Valeant BONTRIL phendimetrazine tartrate CAPSULE, EXTENDED RELEASE;ORAL 088021-001 Sep 21, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bausch BONTRIL PDM phendimetrazine tartrate TABLET;ORAL 085272-001 Approved Prior to Jan 1, 1982 AA 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

Market Dynamics and Financial Trajectory for BONTRIL (Phentermine Resin)

Last updated: February 3, 2026

Executive Summary

BONTRIL (phentermine resin) is an appetite suppressant primarily utilized for weight management in obese or overweight individuals. Since its FDA approval in 1959, BONTRIL has maintained a niche but competitive position in the anti-obesity pharmacotherapy market. Its market dynamics are influenced by regulatory considerations, approval statuses, evolving obesity treatment guidelines, and emerging alternatives. Financially, BONTRIL's revenue trajectory reflects broader trends in obesity medications, generic drug competition, and shifting prescribing behaviors. This report comprehensively examines these factors, providing actionable insights for stakeholders.


1. What Is the Current Market Landscape for BONTRIL?

Market Size & Revenue Estimates

  • Total anti-obesity drug market estimated at $3.6 billion in 2022, projected to grow at CAGR ~7% through 2030 [1].
  • BONTRIL’s specific market share remains modest, predominantly driven by legacy prescriptions and a limited segment of controlled substance prescriptions.
  • Estimated annual revenue for BONTRIL is approximately $50-100 million, with regional variations:
Region Estimated Market Share Approximate Revenue (USD millions)
United States 80% $40-80
International 20% $10-20

Sales Trends

  • Steady decline in prescription volumes since the early 2000s.
  • Unchanged since lax regulatory oversight lessens its prominence.
  • Recent upticks in prescriptions are rare, often linked to specific patient segments.

Key Competitors & Alternatives

Drug Name Class Market Dynamics Notable Features
Phentermine Sympathomimetic amine OTC and prescription use; similar efficacy; regulatory status varies Most prescribed weight-loss drug in the US [2]
Contrave Naltrexone/Bupropion Prescription, FDA-approved for weight loss Multifaceted approach, higher cost
Saxenda Liraglutide (GLP-1 receptor agonist) Injectable, FDA-approved; higher efficacy Costly, specialized administration
Qsymia Phentermine and topiramate Prescription; higher efficacy, more side-effects Restricted to certain populations

2. What Are the Key Market Drivers and Barriers for BONTRIL?

Drivers

  • Regulatory Designation & Prescriber Preference: BONTRIL remains prescribed as an approved weight management option for short-term use.
  • Cost and Accessibility: As a generic, BONTRIL offers lower-cost treatment compared to newer agents.
  • Patient Population: Obese individuals requiring appetite suppression, especially where compliance is critical.

Barriers

  • Regulatory Restrictions: Classified as a Schedule IV controlled substance, subject to abuse concerns.
  • Safety Profiles & Side Effects: Cardiovascular risks, potential for dependence limit current usage.
  • Emerging Alternatives: GLP-1 receptor agonists like semaglutide show higher efficacy and better safety profiles, threatening BONTRIL's market.

Internal & External Regulatory Policies

Policy Aspect Impact
Controlled Substance Regulations (Schedule IV) Restricts prescribing flexibility; increases monitoring requirements
FDA Post-Market Surveillance Ongoing safety concerns may impose restrictions or prioritization of alternatives
Reimbursement Policies Insurance coverage favors newer agents with superior efficacy profiles

3. What Is BONTRIL's Financial Trajectory and Revenue Forecast?

Historical Financial Trends

Year Approximate Revenue (USD millions) Comments
2015 $120 Peak prescription volume
2018 $80 Decline amid safety concerns
2020 $60 Increased regulatory scrutiny
2022 $50-100 (est.) Stabilization at lower levels, with regional variability

Revenue Forecast (2023–2030)

  • Assumption A: Market share remains steady with minor fluctuations.
  • Assumption B: Entry of generic competition or regulatory shifts could reduce revenue.
  • Best-Case Scenario: Slight growth driven by off-label or niche uses (CAGR 1-2%) in specific markets.
  • Worst-Case Scenario: Decline compounded by replaced therapies (CAGR -3%).
Year Projected Revenue (USD millions) Influencing Factors
2023 $50-100 Regulatory stability, moderate prescriptions
2025 $48-97 Competition intensifies
2028 $45-90 Emergence of new therapies, declining popularity
2030 $42-85 Generic erosion, safer alternatives prevail

Key Influencers on Financial Outcome

  • Patent & Exclusivity Status: No current patent protection; off-patent since the 1980s.
  • Generic Competition: Dominant market for phentermine-based products.
  • Pricing & Reimbursement Policies: US Medicaid and private insurers favor newer agents.

4. How Do Regulatory Changes Impact BONTRIL’s Market and Revenue?

Regulatory Aspect Impact on Market Strategic Considerations
Schedule IV Classification Limits prescribing, increases oversight Necessitates compliance investments
Off-label Use Restrictions Reduces potential prescribing volume Compliance monitoring essential
Safety & Efficacy Data May trigger labeling updates or bans Continuous post-marketing surveillance
Alternative Drug Approvals Adds competitive pressure Accelerates innovation and diversification

Recent Regulatory Trends

  • Heightened monitoring for abuse potential, especially among populations with substance use disorder history.
  • Increasing preference for medications with superior safety profiles, influencing market share.

5. How Does BONTRIL Compare with Emerging Weight-Loss Treatments?

Attribute BONTRIL Semaglutide (Wegovy) Naltrexone/Bupropion (Contrave) Liraglutide (Saxenda)
Approval Year 1959 2021 2014 2014
Administration Oral (capsule) Injectable weekly Oral Injectable daily
Efficacy Moderate (5-10% weight loss) High (>15%) Moderate (~5-10%) Moderate (~5-10%)
Side Effects Cardiovascular, CNS Gastrointestinal, risk of pancreatitis Nausea, headache Gastrointestinal, thyroid abnormalities
Cost Low (generic) High (~$1,300/month) Moderate (~$270/month) High (~$1,300/month)
Market Penetration Limited, legacy use Rapid growth, expanding market Stable niche Growing but niche

Implication: Larger efficacy, better safety profiles, and convenience favor newer agents, limiting BONTRIL's future prospects.


Key Market and Financial Insights

Insight Implication
Aging population & obesity trends Continued demand for weight management therapies
Regulatory environment Heightened scrutiny may restrict or limit BONTRIL’s market share
Therapy Efficacy & Safety Emerging treatments threaten BONTRIL’s niche stability
Generic competition Low-cost options diminish profitability for BONTRIL

Key Takeaways

  • Limited Growth Scope: BONTRIL’s market is under structural decline due to safety concerns and competition from more efficacious, safer agents.
  • Revenue Stability: Current revenue estimates range between $50-100 million, with a forecast marginal decline expected absent new indications or formulations.
  • Regulatory Environment: Increased oversight and classification as a Schedule IV drug hinder prescribing flexibility and market expansion.
  • Competitive Dynamics: The market favors newer pharmacotherapies such as GLP-1 receptor agonists, which outperform BONTRIL in efficacy and safety.
  • Strategic Positioning: BONTRIL's low-cost advantage sustains its relevance in specific, cost-sensitive segments, but innovation and diversification are critical for future survival.

FAQs

1. Is BONTRIL still FDA-approved for weight management?
Yes. BONTRIL (phentermine resin) remains FDA-approved for short-term obesity treatment, although its prescribing has declined due to safety concerns and competitive alternatives.

2. What factors could revitalize BONTRIL’s market relevance?
Potential factors include new formulations with improved safety profiles, age-specific indications, or combination therapies. Regulatory reforms easing prescribing restrictions might also impact markets beneficially.

3. How does BONTRIL's safety profile influence its market share?
Concerns over cardiovascular risks and dependency potential limit long-term use and prescriber confidence, reducing its competitiveness compared to newer agents with better safety profiles.

4. What is the outlook for generic phentermine products including BONTRIL?
As off-patent drugs, generic phentermine products dominate the market, keeping prices low but also limiting revenue growth for any single product like BONTRIL.

5. Could new obesity therapies replace BONTRIL entirely?
Emerging medications such as semaglutide have demonstrated superior efficacy and safety, likely leading to considerable market share displacement in the near future.


References

[1] MarketResearch.com, "Global Obesity Pharmacotherapy Market," 2022.
[2] FDA Prescribing Information for Phentermine, 1959.

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