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Last Updated: March 31, 2025

FENOFIBRATE (MICRONIZED) Drug Patent Profile


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Which patents cover Fenofibrate (micronized), and what generic alternatives are available?

Fenofibrate (micronized) is a drug marketed by Ajanta Pharma Ltd, Alembic, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Chartwell, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Norvium Bioscience, Novast Labs, Reyoung, Rhodes Pharms, Rising, and Torrent. and is included in sixteen NDAs.

The generic ingredient in FENOFIBRATE (MICRONIZED) is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-four suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fenofibrate (micronized)

A generic version of FENOFIBRATE (MICRONIZED) was approved as fenofibrate by RHODES PHARMS on May 13th, 2005.

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Drug patent expirations by year for FENOFIBRATE (MICRONIZED)
Recent Clinical Trials for FENOFIBRATE (MICRONIZED)

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SponsorPhase
Beijing Chao Yang HospitalPhase 4
Hanlim Pharm. Co., Ltd.Phase 1
University of IoanninaPhase 4

See all FENOFIBRATE (MICRONIZED) clinical trials

Pharmacology for FENOFIBRATE (MICRONIZED)

US Patents and Regulatory Information for FENOFIBRATE (MICRONIZED)

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Norvium Bioscience FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202579-001 Jan 10, 2013 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Rising FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202676-002 Oct 23, 2012 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Invagen Pharms FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207378-003 Mar 28, 2017 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novast Labs FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207564-002 Apr 19, 2019 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Novast Labs FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207564-003 Apr 19, 2019 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Ajanta Pharma Ltd FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 210705-001 Sep 10, 2018 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Torrent FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 210782-003 Jun 26, 2018 AB RX 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 7 of 7 entries

Market Dynamics and Financial Trajectory for Fenofibrate (Micronized)

Market Overview

The global fibrate drugs market, which includes fenofibrate, is poised for significant growth driven by several key factors. The increasing prevalence of cardiovascular diseases, high triglyceride levels, and the need for effective lipid-lowering medications are primary drivers of this market[3][4].

Market Size and Growth

The fibrate drugs market, including fenofibrate, is expected to grow substantially over the forecast period. The market size was valued at approximately USD 3.18 billion in 2023 and is anticipated to reach USD 5.04 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.3% during this period[3].

Segmentation by Drug Type

Fenofibrate is a dominant segment within the fibrate drugs market. This segment is expected to witness significant growth due to the high efficacy of fenofibrate in lowering triglyceride levels and improving lipid profiles. Clinical trials have demonstrated that fenofibrate reduces total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides, while increasing HDL cholesterol and apoproteins apoAI and apoAII[2][3].

Distribution Channels

The distribution of fenofibrate is segmented into hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies currently command the largest share of the market, driven by the need for close monitoring of patients with cardiovascular and lipid-related conditions. Online pharmacies also play a crucial role, especially in providing primary care and facilitating e-prescribing interoperability solutions[1][4].

Regional Market Dynamics

North America and Europe are significant regions for the fenofibrate market, driven by large-scale production and the presence of major market players such as Abbott. These regions have a high prevalence of cardiovascular diseases, which fuels the demand for fibrate drugs. The Asia Pacific region is also expected to grow at a high CAGR due to a large population with sedentary lifestyles, smoking and drinking habits, and physical inactivity, all of which contribute to abnormal cholesterol levels[1][3][4].

Competitive Landscape

The market for fenofibrate is competitive, with key players including Viatris Inc., Aurobindo Pharma, Lupin Pharmaceuticals, Inc., and AbbVie Inc. The branded segment, particularly dominated by companies like Abbott and Lupin Pharmaceuticals, holds the largest market share due to patents and the high safety and effectiveness profile of their products. However, the entry of generic drug manufacturers is expected to increase competition in the coming years[3][4].

Pharmacokinetics and Metabolism

Fenofibrate is well-absorbed after oral administration, with a peak plasma concentration reached within 4 to 8 hours. It is highly protein-bound (99%) and hydrolyzed into its active metabolite, fenofibric acid, which is further conjugated with glucuronic acid. The drug has a terminal half-life of 20 to 23 hours, allowing for once-daily administration. Approximately 60% of the dose is excreted in the urine, and 25% in the feces[2][5].

Clinical Efficacy

Clinical trials have shown that fenofibrate significantly reduces plasma levels of lipoproteins, fibrinogen, and serum uric acid. It decreases VLDL triglycerides and VLDL cholesterol, making it an effective treatment for hypertriglyceridemia and mixed dyslipidemia. However, the effect of fenofibrate on cardiovascular morbidity and mortality has not been definitively determined[2].

Financial Impact

The production and sale of fenofibrate impose a significant financial impact on the healthcare system. For instance, the annual cost of producing branded formulations of fenofibrate by companies like Abbott is approximately US$ 700 million. This investment, however, contributes positively to the healthcare system by providing effective treatments for lipid-related disorders[1].

Future Opportunities

The future of the fenofibrate market looks promising, driven by increasing research and development activities for managing high triglyceride levels. The growing prevalence of cardiovascular diseases, especially in low-income countries where gastrointestinal tract disorders are more common, presents vast growth opportunities. Additionally, the rising burden of diabetes and coronary artery disease in regions like the Asia Pacific will further drive the market growth[1][3][4].

Challenges and Considerations

Despite the positive outlook, there are challenges to consider. The clofibrate segment, for example, has safety concerns associated with increased cancer risk, which could impact its resurgence in the market. Moreover, the entry of generic drug manufacturers may increase competition and potentially affect the market share of branded products[4].

Key Takeaways

  • The global fibrate drugs market, including fenofibrate, is expected to grow at a CAGR of 5.3% from 2023 to 2032.
  • Fenofibrate is a dominant segment due to its high efficacy in lowering triglycerides and improving lipid profiles.
  • Hospital pharmacies currently command the largest market share, with online pharmacies also playing a significant role.
  • North America and Europe are key regions, with the Asia Pacific region expected to grow rapidly.
  • The market is competitive, with branded products dominating due to their safety and effectiveness.
  • Fenofibrate has a significant financial impact on the healthcare system, with substantial investment in its production.

FAQs

1. What is the expected market size of the fibrate drugs market by 2032?

The fibrate drugs market is anticipated to reach USD 5.04 billion by 2032[3].

2. Which segment dominates the fibrate drugs market?

The fenofibrate segment is expected to witness significant growth and dominate the market due to its high efficacy[2][3].

3. What are the primary distribution channels for fenofibrate?

The primary distribution channels are hospital pharmacies, retail pharmacies, and online pharmacies[1][4].

4. Which regions are significant for the fenofibrate market?

North America, Europe, and the Asia Pacific region are significant due to high prevalence of cardiovascular diseases and large-scale production[1][3][4].

5. What is the impact of fenofibrate on lipid profiles?

Fenofibrate reduces total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides, while increasing HDL cholesterol and apoproteins apoAI and apoAII[2].

Sources:

  1. Maximize Market Research - Fibrate Drugs Market: Global Industry Analysis and Forecast (2023-2029)
  2. Drugs.com - Fenofibrate Capsules: Package Insert / Prescribing Info
  3. Polaris Market Research - Fibrate Drugs Market Size, Demand, Trends, Report, 2024-2032
  4. Grand View Research - Fibrate Drugs Market Size, Share & Trends Report, 2030
  5. NCBI Bookshelf - Fenofibrate - StatPearls

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