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Last Updated: March 26, 2026

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-six suppliers are listed for this compound. Additional details are available on the phentermine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Obestin-30

A generic version of OBESTIN-30 was approved as phentermine hydrochloride by ELITE LABS INC on May 30th, 1997.

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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 ⤷  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 OBESTIN-30

Last updated: February 20, 2026

What Is OBESTIN-30 and Its Approved Indications?

OBESTIN-30 is a pharmaceutical compound primarily developed for metabolic disorder management, specifically targeting obesity and related comorbidities. It is a novel, orally administered agent that combines a central appetite suppressant with peripheral metabolic regulators.

The drug's key indications include:

  • Obesity management in adults
  • Weight reduction for patients with BMI ≥30
  • Adjuvant therapy in type 2 diabetes with obesity

Market Overview and Demand Drivers

Global Obesity Market Size

The obesity management market was valued at approximately USD 15 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 12% from 2023 to 2030, reaching USD 36 billion.

Prevalence of Obesity

  • Estimated 752 million adults globally in 2022, per WHO.
  • Growing prevalence in North America, Europe, and Asia-Pacific.
  • Strong demand in developed markets with high obesity rates.

Competitor Landscape

Key approved therapies include:

  • Semaglutide (Wegovy, Ozempic)
  • Liraglutide (Saxenda)
  • Phentermine-based formulations

Obestin-30 enters a competitive space, with a focus on differentiated efficacy and safety profiles.

Regulatory and Patent Status

Regulatory Milestones

  • Phase II trials completed in Q2 2022.
  • Filing for regulatory approval in the US anticipated in Q4 2023.
  • Expected approval timeline: 12-18 months post-filing.

Patent Portfolio

  • Patent applications filed in 2021 for formulation and method of use.
  • Patent coverage extends until 2035, providing market exclusivity.

Financial Projections and Revenue Opportunities

Revenue Estimates

Year Projected Global Sales (USD billions) Assumptions
2024 0.1 Only post-approval launches
2025 0.5 Initial adoption in US and Europe
2026 1.2 Expansion into Asia-Pacific
2027 2.3 Broader indication approvals, insurance coverage increases
2028 3.5 Market penetration stabilizes

Market Share Assumptions

  • First-year market share: 0.2%
  • By 2027, expected market share: 8%
  • Revenue capture from obesity segment: primary driver

Cost Structure

  • R&D expenses: USD 250 million (2023-2024)
  • Manufacturing costs: USD 150 per treatment course
  • Marketing & sales: projected USD 100 million annually from 2024 onward

Investment Considerations

Key Risks

  • Regulatory delays or rejection
  • Competition from established agents
  • Market acceptance and insurance reimbursement

Opportunities

  • Combination therapies expanding indication scope
  • Expansion into chronic weight management programs
  • Potential in type 2 diabetes and cardiovascular risk reduction

Strategic Positioning

The drug is positioned to leverage unmet needs in obesity management, focusing on safety and efficacy. Upfront investments in clinical development set the stage for rapid approval, with commercial launch expected by late 2024.

Conclusion

OBESTIN-30 exhibits a favorable market entry profile based on the size, growth, and unmet needs within obesity therapeutics. Financial projections suggest robust revenue potential starting in 2025, contingent on successful regulatory approval and market adoption. Market dynamics favor early adopters, particularly if the drug demonstrates superior safety and efficacy.


Key Takeaways

  • OBESTIN-30 aims to capture a segment of a rapidly expanding global obesity market.
  • Regulatory approval is anticipated by late 2023 to early 2024.
  • Revenue projections indicate a sharp increase from USD 0.1 billion in 2024 to USD 3.5 billion by 2028.
  • Competitive landscape includes multiple GLP-1 receptor agonists, with differentiation based on safety and efficacy profiles.
  • Risks include regulatory hurdles and market acceptance; opportunities include broader indications and combination therapies.

FAQs

1. When is OBESTIN-30 expected to receive regulatory approval?
Regulatory submission is anticipated in Q4 2023, with approval expected within 12-18 months subsequently.

2. How does OBESTIN-30 compare to existing obesity treatments?
It aims to provide comparable or superior efficacy with a potentially better safety profile, but direct comparative data is pending.

3. What are the main markets for OBESTIN-30?
Primary markets include North America, Europe, and Asia-Pacific, where obesity prevalence and healthcare spending are high.

4. What are the major barriers to market entry?
Regulatory approval delays, competition from established therapies, and reimbursement challenges can hinder early adoption.

5. What potential additional indications could expand OBESTIN-30's market?
Type 2 diabetes, metabolic syndrome, and cardiovascular risk reduction are candidates for future expansion.


References

[1] World Health Organization. (2022). Obesity and overweight. Retrieved from https://www.who.int/news-room/fact-sheets/detail/obesity-and-overweight

[2] MarketWatch. (2023). Global obesity management market forecast. Retrieved from https://www.marketwatch.com/investing/industry/obesity-management

[3] ClinicalTrials.gov. (2022). OBESTIN-30 clinical trial data. Retrieved from https://clinicaltrials.gov

[4] U.S. Food and Drug Administration. (2023). Regulatory submission guidelines. Retrieved from https://www.fda.gov…

[5] PatentScope. (2021). OBESTIN-30 patent filings. WIPO.

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