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Last Updated: March 18, 2025

CLOFIBRATE Drug Patent Profile


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Summary for CLOFIBRATE
US Patents:0
Applicants:5
NDAs:5
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 8
DailyMed Link:CLOFIBRATE at DailyMed
Drug patent expirations by year for CLOFIBRATE
Recent Clinical Trials for CLOFIBRATE

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SponsorPhase
Instituto Nacional de Salud Publica, MexicoPhase 3
Laboratorios Grossman, S.A.Phase 3
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

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Medical Subject Heading (MeSH) Categories for CLOFIBRATE
Anatomical Therapeutic Chemical (ATC) Classes for CLOFIBRATE

US Patents and Regulatory Information for CLOFIBRATE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Usl Pharma CLOFIBRATE clofibrate CAPSULE;ORAL 070531-001 Jun 16, 1986 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Watson Labs CLOFIBRATE clofibrate CAPSULE;ORAL 071603-001 Sep 18, 1987 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Sandoz CLOFIBRATE clofibrate CAPSULE;ORAL 072191-001 May 2, 1988 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Teva CLOFIBRATE clofibrate CAPSULE;ORAL 072600-001 Jul 25, 1991 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Banner Pharmacaps CLOFIBRATE clofibrate CAPSULE;ORAL 073396-001 Mar 20, 1992 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Market Dynamics and Financial Trajectory for Clofibrate

Overview of Clofibrate

Clofibrate is a fibrate drug used to lower cholesterol and triglyceride levels in the blood. It has been a part of the lipid-lowering therapy arsenal for several decades, although its usage has been impacted by various factors, including safety concerns and the emergence of other treatments.

Global Market Size and Growth

The global fibrate drugs market, which includes clofibrate, is expected to grow significantly over the next few years. The market size was estimated to be around USD 3.25 billion in 2023 and is projected to reach approximately USD 5.41 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 5.22% from 2024 to 2033[1][3][4].

Market Segmentation and Dominance

By Drug Type

The clofibrate segment dominated the fibrate drugs market in 2023 and is anticipated to grow at the fastest rate during the forecast period. However, it is crucial to note that clofibrate has largely fallen out of favor due to safety concerns, particularly its association with an increased risk of cancer. Any potential resurgence would require strong scientific evidence, regulatory backing, and a compelling clinical need[1][3][4].

By Product Type

The branded segment of the fibrate drugs market, which includes clofibrate, held the largest market share in 2023. Branded medications are considered innovators and enjoy patent and exclusivity protections, which can impact the immediate competition from generic versions. However, generic versions of clofibrate, which must adhere to the same quality, strength, and purity standards as their branded counterparts, have increased market competition[1][3].

Regional Market Dynamics

North America

North America dominated the global fibrate drugs market in 2023, with the U.S. market size reaching USD 890 million. This region is expected to continue growing, driven by a well-established healthcare infrastructure, a high rate of cardiovascular diseases, and extensive use of fibrate treatments for lipid disorders. The U.S. market for clofibrate is projected to be worth around USD 1,510 million by 2033, growing at a CAGR of 5.42% from 2024 to 2033[1][4].

Europe

Europe is poised to show the fastest growth in the fibrate drugs market during the projected period. The increasing incidence of cardiovascular diseases and metabolic disorders in the region is driving the demand for effective lipid-lowering treatments like clofibrate. Supportive regulatory policies, rising healthcare spending, and awareness campaigns are also fueling the market growth in Europe[1].

Asia-Pacific

While North America and Europe are significant markets, the Asia-Pacific region is also expected to grow, driven by an increasing incidence of cardiovascular diseases and a growing focus on preventive healthcare[4].

Factors Influencing Market Growth

Increasing Prevalence of Cardiovascular Diseases

The global increase in the prevalence and incidence rate of cardiovascular disorders is a major driver for the fibrate drugs market, including clofibrate. Conditions such as atrial fibrillation, peripheral arterial disease, stroke, and coronary heart disease are becoming more prevalent, leading to a higher demand for lipid-lowering medications[1][3][4].

Regulatory Approvals and Product Launches

Regulatory approvals for generic versions of fibrate drugs have increased market competition and driven demand. For instance, the launch of generic fenofibrate capsules by companies like Lupin has contributed to market growth[4].

Impact of COVID-19

The COVID-19 pandemic had a notable impact on the fibrate drug market. Physical inactivity due to restrictions increased the risk of cardiovascular diseases, thereby raising the demand for fibrate drugs to treat these conditions[4].

Challenges and Limitations

Safety Concerns

Clofibrate has been associated with safety concerns, particularly an increased risk of cancer. This has led to a decline in its usage and any potential resurgence would need substantial scientific evidence and regulatory support[1][3][4].

Regulatory Framework

The market growth is also hindered by frequent product recalls and a stringent regulatory framework. These factors can limit the availability and adoption of clofibrate and other fibrate drugs[4].

Pharmacokinetics and Efficacy

The pharmacokinetics of clofibrate vary among patients, particularly those with familial hypercholesterolemia. Some patients are highly responsive to clofibrate, while others may not respond or even experience adverse effects. Studies have shown differences in plasma clofibric acid levels, bioavailability, and the rate of absorption between responsive and non-responsive patients[2].

Conclusion

The market dynamics for clofibrate are complex, influenced by both positive and negative factors. While the increasing prevalence of cardiovascular diseases and supportive regulatory policies drive demand, safety concerns and a stringent regulatory framework pose challenges. The global fibrate drugs market, including clofibrate, is expected to grow, but the specific trajectory for clofibrate will depend on addressing its safety concerns and gaining regulatory approvals.

Key Takeaways

  • The global fibrate drugs market, including clofibrate, is expected to grow at a CAGR of 5.22% from 2024 to 2033.
  • Clofibrate dominated the market in 2023 but faces challenges due to safety concerns.
  • North America and Europe are significant markets, with North America leading and Europe expected to show the fastest growth.
  • Increasing prevalence of cardiovascular diseases and regulatory approvals drive market growth.
  • Safety concerns and a stringent regulatory framework are major challenges.

FAQs

  1. What is the current market size of the global fibrate drugs market?

    • The global fibrate drugs market size was estimated to be around USD 3.25 billion in 2023[1].
  2. Why has clofibrate fallen out of favor?

    • Clofibrate has largely fallen out of favor due to safety concerns, particularly its association with an increased risk of cancer[1][3][4].
  3. Which region is expected to show the fastest growth in the fibrate drugs market?

    • Europe is expected to show the fastest growth in the fibrate drugs market during the projected period[1].
  4. How has the COVID-19 pandemic impacted the fibrate drugs market?

    • The COVID-19 pandemic increased the risk of cardiovascular diseases due to physical inactivity, thereby raising the demand for fibrate drugs[4].
  5. What are the key drivers for the growth of the fibrate drugs market?

    • The key drivers include the increasing prevalence of cardiovascular diseases, supportive regulatory policies, and rising healthcare spending[1][3][4].

Sources

  1. Precedence Research - Fibrate Drugs Market Size to Worth USD 5.41 Billion by 2033
  2. PubMed - Pharmacokinetics of clofibrate in familial hypercholesterolemia
  3. Grand View Research - Fibrate Drugs Market Size, Share & Trends Report, 2030
  4. Mordor Intelligence - Fibrate Drugs Market - Size, Share & Statistics - Mordor Intelligence

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