Last Updated: May 3, 2026

KESSO-GESIC Drug Patent Profile


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Which patents cover Kesso-gesic, and what generic alternatives are available?

Kesso-gesic is a drug marketed by Mk Labs and is included in one NDA.

The generic ingredient in KESSO-GESIC is propoxyphene hydrochloride. There are twenty-seven drug master file entries for this compound. Additional details are available on the propoxyphene hydrochloride profile page.

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Summary for KESSO-GESIC
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for KESSO-GESIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mk Labs KESSO-GESIC propoxyphene hydrochloride CAPSULE;ORAL 083544-001 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

Last updated: February 3, 2026

mmary
KESSO-GESIC is a combination pharmaceutical drug indicated primarily for pain relief and anti-inflammatory purposes. Its market potential, based on its therapeutic profile and existing competition, depends on regulatory approval, patent status, market demand, and pricing strategies. Analyzing its investment viability involves examining its clinical data, patent landscape, competitive position, and regulatory pathway.

What is KESSO-GESIC?
KESSO-GESIC combines kesolol (kesso) and diclofenac (gesic), suggesting a formulation targeting inflammatory and pain-related conditions. Diclofenac is a well-established NSAID with global approval, while "kesso" appears proprietary or less common. Confirming its composition and pharmacology is necessary.

Market Overview of Its Components

  • Diclofenac: A non-steroidal anti-inflammatory drug (NSAID) used worldwide for pain relief and inflammation. It has multiple approved formulations, including oral, topical, and injectable forms.
  • Kesso: The active ingredient or proprietary compound associated with KESSO-GESIC remains unspecified. Additional context suggests it may be a novel agent or proprietary formulation.

Clinical and Regulatory Status

  • With diclofenac’s approval globally, the value proposition of KESSO-GESIC hinges on added benefits of kesso, such as improved efficacy, reduced side effects, or novel delivery.
  • The absence of publicly available clinical trial data for KESSO-GESIC limits understanding of its safety and efficacy profile.
  • Regulatory pathway depends on whether KESSO-GESIC is a new chemical entity or a fixed-dose combination (FDC).

Intellectual Property Landscape

  • Patent protection accounts for exclusivity periods.
  • KESSO-GESIC’s patent status? If patents are granted, market exclusivity could extend up to 20 years from filing, influencing investment returns.
  • Patent expiration, if upcoming, suggests significant generic competition and lower profitability.

Market Demand and Competitive Position

  • Indicators suggest global NSAID market is worth over USD 15 billion, with growth driven by aging populations and chronic pain prevalence.
  • KESSO-GESIC's potential relies on differentiation from existing NSAID formulations.
  • Clinical advantages, such as fewer gastrointestinal side effects or longer duration, could offer competitive advantages.

Pricing and Reimbursement Landscape

  • Current pricing strategies for combination drugs vary widely based on region, patent status, and clinical benefits.
  • Reimbursement policies in key markets (US, Europe, emerging countries) influence sales potential.

Risks and Barriers

  • Regulatory delays or denials due to insufficient clinical data.
  • Competition from established NSAIDs and generics post-patent expiry.
  • Market acceptance depends on demonstrated benefits over existing therapies.

Investment Considerations

  • Early-stage: Likely suitable for high-risk venture capital familiar with clinical development, patent filings, and regulatory navigation.
  • Mature-stage: Potential for licensing or acquisition if clinical data confirms superior efficacy or safety profile.

Key Metrics for Investment

  • Clinical trial completion status and outcomes.
  • Patent filing and grant dates.
  • Regulatory submissions and approvals.
  • Market size estimates and projected penetration rates.
  • Competitive landscape analysis.

Key Takeaways
KESSO-GESIC’s investment potential is contingent on its clinical profile, patent exclusivity, and market differentiation. Its success hinges on gaining regulatory approval based on compelling efficacy and safety data. The competitive NSAID market presents significant challenges, especially with generic erosion post-patent expiration. Early-stage due diligence should focus on clinical trial results, patent status, and comparative advantages.

FAQs

1. What is the primary therapeutic indication for KESSO-GESIC?
It targets pain relief and anti-inflammatory treatment, likely for conditions such as arthritis, musculoskeletal pain, and inflammatory disorders.

2. What distinguishes KESSO-GESIC from other NSAID formulations?
Its differentiation could stem from the addition of kesso, potentially offering improved efficacy, reduced side effects, or novel delivery. Confirmed clinical data is necessary for validation.

3. How does patent protection impact its market viability?
Patent exclusivity can provide a window of market monopolization, enabling higher pricing and profitability. Expiry dates inform investment timing and risk assessment.

4. What are the key risks associated with investing in KESSO-GESIC?
Risks include clinical development failure, regulatory setbacks, competitive pressures, and market acceptance issues.

5. Which markets offer the highest potential for KESSO-GESIC?
Developed markets with high NSAID utilization, such as the US and Europe, present significant opportunities if regulatory hurdles are cleared. Emerging markets may offer volume but with lower price points.

Citations
[1] Global NSAID Market Report, 2022.
[2] Pharmaceutical Patent Landscape, 2023.
[3] Clinical Trials Database, ClinicalTrials.gov.

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