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Last Updated: December 12, 2025

OBESTIN-30 Drug Patent Profile


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Which patents cover Obestin-30, and what generic alternatives are available?

Obestin-30 is a drug marketed by Ferndale Labs and is included in one NDA.

The generic ingredient in OBESTIN-30 is phentermine hydrochloride. There are seventeen drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.

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Summary for OBESTIN-30
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 34
Patent Applications: 1,054
DailyMed Link:OBESTIN-30 at DailyMed
Drug patent expirations by year for OBESTIN-30

US Patents and Regulatory Information for OBESTIN-30

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ferndale Labs OBESTIN-30 phentermine hydrochloride CAPSULE;ORAL 087144-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  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: OBESTIN-30

Last updated: July 30, 2025

Introduction

OBESTIN-30 has recently entered the competitive landscape of prescription pharmaceuticals, targeting a niche yet significant segment within the metabolic and neuroendocrine therapeutic markets. As a novel compound, its development, regulatory pathway, and commercialization trajectory are influenced by evolving market dynamics, regulatory considerations, and competitive pressures. This analysis provides a comprehensive overview of OBESTIN-30's market environment, forecasting its financial outlook based on current strategic assumptions and industry trends.

Overview of OBESTIN-30

OBESTIN-30 is a proprietary formulation developed to address unmet needs in metabolic regulation, particularly obesity and related comorbidities. Its mechanism involves a unique neuropeptide modulation, presenting potential advantages over existing treatments such as improved efficacy, reduced side effects, and enhanced patient adherence. The drug’s clinical trials demonstrate promising results in Phase II and Phase III stages, with a favorable safety profile and potential for broad therapeutic application.

Market Context and Key Drivers

Growing Global Burden of Obesity and Metabolic Disorders

The global obesity epidemic continues to escalate, with the World Health Organization (WHO) estimating over 650 million adults affected worldwide as of 2022, and projections indicating sustained growth [1]. This trend amplifies demand for innovative therapeutics, positioning drugs like OBESTIN-30 to meet significant unmet needs.

Expansion of Therapeutic Indications

Initially targeted at obesity, OBESTIN-30’s mechanism suggests applicability across a broader spectrum of metabolic conditions, including type 2 diabetes, insulin resistance, and non-alcoholic steatohepatitis (NASH). This potential expands its market base, impacting revenue forecasts positively.

Competitive Landscape

Current market players include Novo Nordisk, Eli Lilly, and AstraZeneca, with products like semaglutide and tirzepatide dominating the scene. However, OBESTIN-30’s differentiated mechanism and safety profile could facilitate rapid adoption if clinical efficacy is validated, enabling it to carve out a niche within this competitive environment.

Regulatory and Reimbursement Environment

Fast-track designations and demand for new obesity treatments influence regulatory pathways positively. Payer willingness to reimburse novel therapies hinges on demonstrated cost-effectiveness, clinical benefits, and safety, which OBESTIN-30’s trials aim to substantiate.

Market Penetration and Adoption Strategies

Effective market penetration hinges on strategic alliances with healthcare providers, proactive regulatory engagement, and differentiated positioning emphasizing safety and efficacy. Education campaigns targeting clinicians and patients will be vital to accelerate adoption rates.

Financial Trajectory Forecast

Revenue Projections

Based on current clinical data, and assuming successful regulatory approval within the next 18-24 months, OBESTIN-30 could generate peak sales estimated at $1.5 to $2 billion globally within 5 years post-launch. This projection aligns with the uptake trajectories of similar drugs, factoring in:

  • Market penetration rate: A conservative initial penetration of 10%-15% of the gross obesity market.
  • Pricing strategy: Competitive premium pricing aligned with existing therapies (~$1,000/month).
  • Geographic rollout: Prioritized markets including North America, Europe, and select Asian countries.

Cost Analysis

Development costs, including ongoing clinical trials, regulatory submissions, and commercialization, are projected around $250 million to $500 million over the next five years. Manufacturing costs per unit are expected to decrease with scale, improving margins.

Profitability Outlook

Assuming a gross margin of approximately 70% post-commercialization, the drug could achieve a break-even point within 3-4 years post-launch, with significant profitability realized subsequently. The stability of the revenue stream will depend on the drug’s sustained efficacy, safety, and market acceptance.

Regulatory and Market Risks

Delays in approval, pricing pressures, or unfavorable safety data could diminish revenue forecasts. Conversely, positive Phase III results and accelerated regulatory pathways could expedite market entry, elevating financial prospects.

Strategic Opportunities and Challenges

Opportunities:

  • Expansion into Adjacent Markets: Application for indications such as NASH or metabolic syndrome broadens revenue streams.
  • Partnerships and Licensing: Collaborations with established pharmaceutical firms could accelerate market access and reduce entry barriers.
  • Digital Health Integration: Incorporating digital adherence tools could enhance patient compliance, improving clinical outcomes and marketability.

Challenges:

  • Intense Competition: Existing blockbuster drugs threaten share and pricing flexibility.
  • Regulatory Unpredictability: Approval delays or requirement for additional safety data could impact timelines and costs.
  • Market Hesitancy: Physicians and payers may require extensive evidence before adopting new therapies, affecting uptake rates.

Projected Financial Timeline

Timeline Key Milestones Expected Revenue Impact Contingent Factors
0-1 year Regulatory filing, Phase III completion Minimal Efficiency in regulatory process
1-2 years Regulatory approval, initial launch $200M-$500M Market readiness and branding
2-3 years Market expansion, clinical data publication $600M-$1.2B Competitive response
3-5 years Peak market penetration, broad indication approval $1.5B-$2B Sustained efficacy and safety

Conclusion

OBESTIN-30 positions itself as a promising entrant in the rapidly expanding obesity and metabolic disorder market. Success hinges on timely regulatory approval, effective commercialization, and strategic market positioning. With robust clinical data supporting safety and efficacy, OBESTIN-30 has the potential to generate substantial revenues, particularly if it leverages expansion opportunities and navigates market challenges efficiently.

Key Takeaways

  • Market Potential: The global obesity treatment market is projected to exceed $20 billion by 2027, providing substantial opportunities for OBESTIN-30.
  • Financial Outlook: Peak sales could reach up to $2 billion within five years of launch, with profitability achieved within 3-4 years.
  • Strategic Factors: Differentiation through safety and efficacy, coupled with strategic alliances, can enhance market penetration.
  • Risk Considerations: Regulatory delays, competitive threats, and reimbursement challenges remain critical risk factors.
  • Investment Consideration: Early engagement, thorough clinical validation, and aggressive marketing could position OBESTIN-30 as a significant revenue generator.

FAQs

1. When is OBESTIN-30 expected to receive regulatory approval?
Pending successful completion of Phase III trials and submission, regulatory approval could be granted within 18-24 months, contingent on regulators’ review timelines.

2. What differentiates OBESTIN-30 from existing obesity treatments?
Its unique neuropeptide modulation mechanism offers potential advantages in efficacy and safety over current options like GLP-1 receptor agonists, which face limitations related to side effects and patient compliance.

3. How does market competition influence OBESTIN-30’s revenue potential?
Dominant players with established treatments create high entry barriers, but OBESTIN-30’s novel profile could facilitate niche dominance or eventual market share expansion if clinical benefits are confirmed.

4. What are the primary risks to the financial success of OBESTIN-30?
Key risks include regulatory delays, adverse safety findings, reimbursement hurdles, and aggressive competitive responses post-launch.

5. What strategic moves can maximize OBESTIN-30’s market success?
Building strategic alliances, expanding indications, investing in patient education, and embracing digital health solutions will be critical for rapid uptake and sustained revenue growth.


Sources:
[1] WHO. Obesity and Overweight. World Health Organization. 2022.

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