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Last Updated: January 2, 2025

Nifurtimox - Generic Drug Details


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What are the generic sources for nifurtimox and what is the scope of patent protection?

Nifurtimox is the generic ingredient in one branded drug marketed by Bayer Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for nifurtimox
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 39
Clinical Trials: 22
Patent Applications: 10
What excipients (inactive ingredients) are in nifurtimox?nifurtimox excipients list
DailyMed Link:nifurtimox at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for nifurtimox
Generic Entry Date for nifurtimox*:
Constraining patent/regulatory exclusivity:
INDICATED IN PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE AND WEIGHING AT LEAST 2.5 KG) FOR THE TREATMENT OF CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS) CAUSED BY TRYPANOSOMA CRUZI
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for nifurtimox

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

SponsorPhase
Juan D. MayaPhase 2
Drugs for Neglected Diseases initiativePhase 3
Laboratorio Elea Phoenix S.A.Phase 3

See all nifurtimox clinical trials

US Patents and Regulatory Information for nifurtimox

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Healthcare LAMPIT nifurtimox TABLET;ORAL 213464-002 Aug 6, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Healthcare LAMPIT nifurtimox TABLET;ORAL 213464-002 Aug 6, 2020 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Healthcare LAMPIT nifurtimox TABLET;ORAL 213464-001 Aug 6, 2020 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Bayer Healthcare LAMPIT nifurtimox TABLET;ORAL 213464-001 Aug 6, 2020 RX Yes No ⤷  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

Nifurtimox Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Nifurtimox

Introduction to Nifurtimox

Nifurtimox, marketed under the brand name Lampit by Bayer, is one of the two primary drugs approved for the treatment of Chagas disease, a parasitic infection caused by Trypanosoma cruzi. Here, we delve into the market dynamics and financial trajectory of nifurtimox, highlighting key factors influencing its market performance.

Market Size and Growth

The global Chagas disease drug market, which includes nifurtimox, is projected to grow significantly. As of 2022, the market size was valued at USD 265.2 million, and it is expected to reach USD 520.4 million by 2032, growing at a Compound Annual Growth Rate (CAGR) of 7.1% from 2023 to 2032[1].

Market Drivers

Several factors drive the growth of the nifurtimox market:

  • Increasing Incidence of Chagas Disease: The rising number of cases, particularly in non-endemic regions, fuels the demand for effective treatments like nifurtimox[1][4].
  • Government Initiatives: Government programs and initiatives to control and prevent Chagas disease, such as those by the Centers for Disease Control and Prevention (CDC), enhance the availability and accessibility of nifurtimox[1][2].
  • Research and Development: Ongoing R&D activities aimed at developing more effective treatments and addressing the limitations of current drugs like nifurtimox contribute to market growth[1][4].

Market Restraints

Despite the positive trends, several challenges restrain the market:

  • Adverse Events: Nifurtimox is associated with a high frequency of adverse events, with 91.4% of treated patients reporting at least one adverse event. This includes gastrointestinal, neurologic, and constitutional symptoms, which can impact patient compliance and market growth[2].
  • Limited Approved Products: The current market has only a few approved drugs for Chagas disease, which limits treatment options and can slow market expansion[1][4].
  • Supply Chain Issues: Problems in the supply chain, including stock-outs and logistical challenges, can hinder the availability of nifurtimox and other Chagas disease drugs[1][5].

Distribution Channels

The distribution of nifurtimox is crucial for its market performance. Retail pharmacies are expected to witness significant growth due to their accessibility and the wide range of medications they offer. This segment is driven by factors such as increasing availability of drugs through retail pharmacies and growing disease awareness[1].

Regional Outlook

North America dominates the Chagas disease drug market, including nifurtimox, due to high disease prevalence, favorable government initiatives, and established healthcare infrastructure. The CDC's programs and the FDA's approval of nifurtimox have significantly contributed to its availability in this region[1].

Financial Trajectory

The financial trajectory of nifurtimox is influenced by several factors:

  • FDA Approval and Commercial Availability: The FDA's approval of nifurtimox (Lampit) in 2020 marked a significant milestone, making the drug commercially available and improving access to therapy for approximately 300,000 estimated persons with Chagas disease in the United States[2].
  • Priority Review Vouchers: The Tropical Disease Priority Review Voucher Program can impact the financial dynamics. While nifurtimox itself has not been directly associated with a PRV sale, such vouchers can influence the development and approval of other tropical disease treatments, potentially affecting market dynamics[3].
  • Sales and Revenue: The increasing demand for nifurtimox, driven by growing awareness and government initiatives, is expected to contribute to higher sales and revenue. However, the financial performance can be affected by the drug's adverse event profile and supply chain issues[1][2].

Key Players and Market Competition

Bayer AG, the manufacturer of nifurtimox (Lampit), plays a significant role in the market. Other key players, such as Merck & Co., Inc., Sanofi S.A., and Teva Pharmaceutical Industries Ltd., also influence the market dynamics through their involvement in Chagas disease treatment research and development[1].

Future Outlook

The future outlook for nifurtimox is promising but challenging:

  • Increasing Demand: The growing incidence of Chagas disease and the need for more effective treatments are expected to drive demand for nifurtimox.
  • Research and Development: Ongoing R&D efforts aimed at improving treatment efficacy and reducing adverse events will be crucial for the drug's long-term success.
  • Access Initiatives: Programs aimed at improving access to nifurtimox, such as those facilitated by the Tropical Disease Priority Review Voucher Program, will be essential in expanding the drug's reach[1][3][4].

Key Takeaways

  • Market Growth: The Chagas disease drug market, including nifurtimox, is expected to grow at a CAGR of 7.1% from 2023 to 2032.
  • Adverse Events: Nifurtimox is associated with significant adverse events, which can impact market growth.
  • Distribution Channels: Retail pharmacies are expected to play a crucial role in the distribution of nifurtimox.
  • Regional Dominance: North America leads the market due to high disease prevalence and favorable government initiatives.
  • Financial Trajectory: FDA approval and commercial availability have improved access to nifurtimox, but supply chain issues and adverse events remain challenges.

FAQs

Q: What is the current market size of the global Chagas disease drug market? A: As of 2022, the market size was valued at USD 265.2 million[1].

Q: What is the expected CAGR of the Chagas disease drug market from 2023 to 2032? A: The market is expected to grow at a CAGR of 7.1% from 2023 to 2032[1].

Q: Which region dominates the Chagas disease drug market? A: North America dominates the market due to high disease prevalence and favorable government initiatives[1].

Q: What are the common adverse events associated with nifurtimox? A: Common adverse events include gastrointestinal, neurologic, and constitutional symptoms such as nausea, anorexia, weight loss, headache, and abdominal pain[2].

Q: How has FDA approval impacted the availability of nifurtimox? A: FDA approval in 2020 made nifurtimox (Lampit) commercially available, improving access to therapy for patients with Chagas disease[2].

Cited Sources

  1. Acumen Research and Consulting - Chagas Disease Drug Market Size to Grow CAGR Rate of 7.1 ...
  2. CDC - Characteristics and Adverse Events of Patients for Whom Nifurtimox
  3. Rethink Priorities - Priority review vouchers for tropical diseases: Impact, distribution ...
  4. Allied Market Research - Chagas Disease Treatment Market Size, Share and Trends | 2019
  5. PLOS - Barriers to Treatment Access for Chagas Disease in Mexico - PLOS

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