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Last Updated: December 22, 2024

BENZNIDAZOLE Drug Patent Profile


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Which patents cover Benznidazole, and what generic alternatives are available?

Benznidazole is a drug marketed by Chemo Research Sl and is included in one NDA.

The generic ingredient in BENZNIDAZOLE is benznidazole. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the benznidazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Benznidazole

A generic version of BENZNIDAZOLE was approved as benznidazole by CHEMO RESEARCH SL on August 29th, 2017.

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Summary for BENZNIDAZOLE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 77
Clinical Trials: 22
Patent Applications: 1,654
What excipients (inactive ingredients) are in BENZNIDAZOLE?BENZNIDAZOLE excipients list
DailyMed Link:BENZNIDAZOLE at DailyMed
Drug patent expirations by year for BENZNIDAZOLE
Recent Clinical Trials for BENZNIDAZOLE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
IC-MedTech CorporationPhase 1
Juan D. MayaPhase 2
Drugs for Neglected Diseases initiativePhase 3

See all BENZNIDAZOLE clinical trials

US Patents and Regulatory Information for BENZNIDAZOLE

BENZNIDAZOLE is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Chemo Research Sl BENZNIDAZOLE benznidazole TABLET;ORAL 209570-001 Aug 29, 2017 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chemo Research Sl BENZNIDAZOLE benznidazole TABLET;ORAL 209570-002 Aug 29, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

BENZNIDAZOLE Market Analysis and Financial Projection Experimental

Benznidazole: Market Dynamics and Financial Trajectory

Introduction

Benznidazole is a crucial antiparasitic drug used in the treatment of Chagas disease, a serious and sometimes life-threatening illness caused by the parasite Trypanosoma cruzi. Here, we delve into the market dynamics and financial trajectory of benznidazole, exploring its current status, future outlook, and the factors influencing its market growth.

Global Market Share and Dominance

Benznidazole holds the most significant global market share in the Chagas disease treatment market. It is anticipated to continue dominating the market during the forecast period due to its high efficacy, particularly in the early stages of the disease, where it inhibits the replication of Trypanosoma cruzi[1].

Treatment Segment Growth

The antiparasitic treatment segment, which includes benznidazole and nifurtimox, dominates the Chagas disease market revenue. This dominance is driven by the increased prevalence of Chagas disease worldwide and the direct targeting of the parasites by these drugs. Benznidazole's effectiveness in reducing the rate of progression to cardiomyopathy and lowering mortality rates further enhances its market position[1][2].

Regional Market Performance

North America

The North American region, particularly the United States, holds a notable market share due to favorable government regulations and the rising prevalence of Chagas disease. According to the CDC, approximately 300,000 people in the U.S. are affected by Chagas disease, driving the demand for therapeutic drugs like benznidazole[1].

Asia Pacific

The Asia Pacific region is expected to experience rapid growth in the coming years. Factors such as rapid industrialization, growing urbanization, and increasing disposable incomes are driving the healthcare industry's growth, which in turn boosts the demand for quality healthcare and drugs like benznidazole[1].

Europe

Europe is also expected to see considerable growth during the forecast period. The well-established healthcare infrastructure and pharmaceutical industry, along with a favorable regulatory network, are key drivers of market growth in this region[1].

Regulatory Approvals and Impact

Regulatory approvals play a significant role in the market growth of benznidazole. For instance, in April 2018, the Argentinian National Administration for Drugs, Food, and Medical Technologies (ANMAT) approved Laboratorio Elea Phoenix SA’s benznidazole for pediatric indication, which is expected to fuel market growth in regions with high prevalence rates like Argentina[4].

Manufacturing and Distribution

Benznidazole's manufacturing and distribution have undergone significant changes. Initially manufactured by Roche until 2003, the rights and technology were transferred to Laboratorio Farmaceutico do Estado Pernambuco (LaFepe) in Brazil. LaFepe resumed production in 2011, and the drug is now distributed by several entities including LaFepe, WHO, and Masters Pharmaceuticals[5].

Financial Trajectory

The global Chagas disease treatment market, which includes benznidazole, was valued at US$ 5.67 million in 2016 and is expected to witness a Compound Annual Growth Rate (CAGR) of 7.3% over the forecast period (2017-2025)[4].

Barriers to Access

Despite its market growth, access to benznidazole is hindered by several barriers, including financing issues. The regulatory status of benznidazole and nifurtimox affects the financing available for these medicines. Additionally, gaps in treatment access, particularly in regions with limited healthcare infrastructure, pose significant challenges[5].

Future Outlook

The future outlook for benznidazole is cautiously optimistic. Ongoing research into new treatments, the development of better diagnostic tools, and increasing global awareness of Chagas disease are expected to drive market growth. Innovations in nanomedicine, such as the creation of new nanotechnological drug delivery systems, could also enhance the efficacy and safety of benznidazole, further boosting its market position[1][3].

Key Players

Several key players are involved in the production and distribution of benznidazole, including Nortec Quimica SA, Bayer AG, Laboratorio Elea Phoenix SA, Novartis Pharmaceuticals, and others. These companies play a crucial role in ensuring the availability and accessibility of the drug[1].

Impact of Nanomedicine

Research initiatives like the BERENICE project are exploring the use of nanomedicine to improve the pharmacokinetics and pharmacodynamics of benznidazole. This could lead to lower medicine doses, safer medications, and increased efficacy, which would positively impact the market growth of benznidazole[3].

Clinical Efficacy

Studies have shown that benznidazole treatment results in a declining antibody trajectory and reduced progression to cardiomyopathy. For instance, patients who tested PCR-negative at 36 months after treatment initiation showed an earlier and more significant decline in serological values, indicating the drug's effectiveness[2].

"Benznidazole (BNZ) is the primary treatment available for Chagas disease worldwide. The evidence base supporting treatment with BNZ comes primarily from retrospective observational studies that have documented a reduced rate of progression to cardiomyopathy and lower mortality in BNZ-treated patients"[2].

Socio-Economic Impact

The socio-economic impact of benznidazole is significant, particularly in regions heavily affected by Chagas disease. Improvements in treatment access and efficacy can lead to better health outcomes, reduced healthcare costs, and enhanced economic productivity.

Conclusion

Benznidazole remains a cornerstone in the treatment of Chagas disease, driven by its high efficacy and regulatory approvals. The market is expected to grow as new products are developed, and global awareness of the disease increases. However, barriers to access and financing issues need to be addressed to ensure widespread availability of this critical antiparasitic drug.

Key Takeaways

  • Benznidazole dominates the global Chagas disease treatment market due to its high efficacy.
  • Regulatory approvals and favorable government regulations drive market growth.
  • The Asia Pacific and European regions are expected to see significant growth.
  • Barriers to access, including financing issues, need to be addressed.
  • Innovations in nanomedicine could enhance the drug's efficacy and safety.
  • Key players play a crucial role in ensuring the drug's availability.

FAQs

What is the primary treatment for Chagas disease?

Benznidazole is the primary treatment available for Chagas disease worldwide.

Which regions are expected to see significant growth in the Chagas disease treatment market?

The Asia Pacific and European regions are expected to experience rapid growth in the coming years.

What are the main barriers to accessing benznidazole?

Barriers include financing issues, gaps in treatment access, and limited healthcare infrastructure in some regions.

How does nanomedicine impact the market for benznidazole?

Nanomedicine could lead to lower medicine doses, safer medications, and increased efficacy, boosting the market position of benznidazole.

Which companies are key players in the production and distribution of benznidazole?

Key players include Nortec Quimica SA, Bayer AG, Laboratorio Elea Phoenix SA, and Novartis Pharmaceuticals.

Sources

  1. Marketdataforecast.com: Chagas Disease Market Size, Share, Growth & Analysis, 2032
  2. Frontiersin.org: Parasitemia and antibody response to benznidazole treatment in a ...
  3. Cordis.europa.eu: Benznidazol and Triazol REsearch group for Nanomedicine and ...
  4. Coherentmarketinsights.com: Chagas Disease Treatment Market - Price, Size, Share & Growth
  5. PLOS.org: Barriers to Treatment Access for Chagas Disease in Mexico - PLOS

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