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Last Updated: December 23, 2024

Auranofin - Generic Drug Details


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What are the generic drug sources for auranofin and what is the scope of freedom to operate?

Auranofin is the generic ingredient in one branded drug marketed by Sebela Ireland Ltd and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for auranofin. One supplier is listed for this compound.

Summary for auranofin
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 7
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 34
Clinical Trials: 13
Patent Applications: 130
What excipients (inactive ingredients) are in auranofin?auranofin excipients list
DailyMed Link:auranofin at DailyMed
Recent Clinical Trials for auranofin

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

SponsorPhase
University of UlmPhase 1/Phase 2
The Aurum Institute NPCPhase 2
Reliable Cancer TherapiesPhase 1/Phase 2

See all auranofin clinical trials

Medical Subject Heading (MeSH) Categories for auranofin

US Patents and Regulatory Information for auranofin

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sebela Ireland Ltd RIDAURA auranofin CAPSULE;ORAL 018689-001 May 24, 1985 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

Expired US Patents for auranofin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sebela Ireland Ltd RIDAURA auranofin CAPSULE;ORAL 018689-001 May 24, 1985 ⤷  Subscribe ⤷  Subscribe
Sebela Ireland Ltd RIDAURA auranofin CAPSULE;ORAL 018689-001 May 24, 1985 ⤷  Subscribe ⤷  Subscribe
Sebela Ireland Ltd RIDAURA auranofin CAPSULE;ORAL 018689-001 May 24, 1985 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Auranofin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Auranofin

Overview of Auranofin

Auranofin, an oral gold compound, is primarily used in the treatment of rheumatoid arthritis and other autoimmune disorders. It is known for its anti-inflammatory and immunomodulatory properties, making it a valuable option for patients who do not respond well to conventional treatments[1][4][5].

Market Growth and Projections

The global Auranofin market is experiencing steady growth, driven by several key factors:

  • Increasing Prevalence of Rheumatoid Arthritis: The rising prevalence of rheumatoid arthritis and the need for alternative treatments are fundamental growth drivers. This trend is expected to continue, driving the market forward[1][4].
  • Advancements in Drug Delivery Systems: Improvements in drug delivery systems are enhancing the efficacy and patient compliance of Auranofin, contributing to market growth[1][4].
  • Government and Non-Government Funding: Increased funding for chronic diseases and cancer research from both governmental and non-governmental organizations is supporting the expansion of the Auranofin market[4].

The market size was estimated at USD 209.20 million in 2023 and is expected to reach USD 218.99 million in 2024, with a projected CAGR of 4.81% to reach USD 290.85 million by 2030[4].

Regional Analysis

The Auranofin market exhibits significant regional variations:

  • North America and Europe: These regions are the dominant markets due to the high prevalence of rheumatoid arthritis, well-established healthcare infrastructure, and favorable reimbursement policies[1][4].
  • Asia-Pacific: This region is anticipated to show significant growth due to rapidly evolving healthcare systems, increasing patient awareness, and a growing prevalence of rheumatoid arthritis. Countries like China and India are expected to contribute substantially to the market[1][4].
  • Latin America, Middle East, and Africa: These regions offer untapped opportunities for market expansion, driven by growing healthcare infrastructure and investment[1][4].

Market Drivers

Several factors are driving the growth of the Auranofin market:

  • Increasing Awareness about Autoimmune Disorders: Growing awareness among patients and healthcare professionals about the impact of autoimmune disorders on quality of life has led to higher demand for effective treatment options like Auranofin[1].
  • Potential in New Therapeutic Areas: Research demonstrating Auranofin's efficacy against certain cancers, parasites, and as an antiviral agent is expanding its market potential[4][5].
  • Government Initiatives and Funding: Increased government initiatives to improve patient access to effective treatments and funding for chronic diseases and cancer research are driving market growth[1][4].

Market Restraints

Despite the positive growth trajectory, the Auranofin market faces several challenges:

  • Side Effects: Side effects such as gastrointestinal issues and dermatological reactions limit its acceptability among some patients[4][5].
  • Regulatory Hurdles: The complex regulatory landscape and the high cost of clinical trials for new applications are significant challenges[4].
  • Competition from Alternative Treatments: Growing competition from newer biologic DMARDs and biosimilars poses challenges to its market share[4].

Competitive Landscape

The Auranofin market is characterized by the presence of both branded and generic products, creating competition among manufacturers:

  • Revenue Generation: The market presents significant revenue generation opportunities for pharmaceutical companies through both branded and generic versions of the drug[1].
  • Market Expansion: Exploring new therapeutic areas and expanding into emerging markets can help industry participants expand their market presence and increase their customer base[1][4].
  • Collaborative Opportunities: Collaborations with research institutions, healthcare organizations, and other industry players can lead to the development of innovative formulations and improved treatment approaches[1].

SWOT Analysis

Strengths

  • Efficacy in Treating Rheumatoid Arthritis: Auranofin's proven efficacy in treating rheumatoid arthritis and other autoimmune disorders is a significant strength[1][5].
  • Diverse Therapeutic Applications: Its potential in treating various conditions, including certain cancers and parasitic infections, expands its market opportunities[4][5].

Weaknesses

  • Side Effects: The drug's side effects, such as gastrointestinal issues and dermatological reactions, can limit its acceptance among patients[4][5].
  • Regulatory Challenges: The complex regulatory landscape and high costs associated with clinical trials for new applications are significant weaknesses[4].

Opportunities

  • Exploration of New Therapeutic Areas: The potential of Auranofin in new therapeutic areas, such as oncology and parasitology, presents significant growth opportunities[4][5].
  • Partnerships and Collaborations: Partnerships between pharmaceutical companies and research institutions can lead to innovative formulations and expanded market presence[1][4].

Threats

  • Competition from Alternative Treatments: The availability of alternative treatments, including newer biologic DMARDs and biosimilars, poses a threat to Auranofin's market share[4].
  • Patent Expiration: The expiration of patents could lead to increased competition from generic versions, potentially impacting revenue[1].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the Auranofin market:

  • Temporary Decline in Demand: The disruption in healthcare services and diversion of resources towards managing the pandemic led to a temporary decline in the demand for Auranofin[1].
  • Increased Awareness: However, the pandemic highlighted the importance of effective treatment options for chronic diseases and immune disorders, which is expected to drive market growth in the post-pandemic period[1].

Cost Effectiveness

Studies have shown that Auranofin is cost-effective in the treatment of rheumatoid arthritis. For instance, a randomized clinical trial indicated that the additional medical costs directly associated with Auranofin treatment amounted to $778 per patient annually, with negligible differences in less direct medical costs compared to placebo[2].

Future Outlook

The future of the Auranofin market appears promising, with steady growth anticipated in the coming years:

  • Increasing Prevalence of Autoimmune Disorders: The rising prevalence of autoimmune disorders and advancements in drug delivery systems are expected to drive market expansion[1][4].
  • Research and Development: Expanding research activities and potential applications in new therapeutic areas, such as oncology and parasitology, will further drive market growth[4][5].

Key Takeaways

  • The Auranofin market is driven by its efficacy in treating rheumatoid arthritis and other autoimmune disorders.
  • The market is expected to grow at a CAGR of 4.81% to reach USD 290.85 million by 2030.
  • Regional variations, with North America and Europe leading, and significant growth anticipated in the Asia-Pacific region.
  • Challenges include side effects, regulatory hurdles, and competition from alternative treatments.
  • Opportunities exist in exploring new therapeutic areas and partnerships between pharmaceutical companies and research institutions.

FAQs

Q: What is the primary indication for Auranofin?

A: The primary indication for Auranofin is the treatment of rheumatoid arthritis, particularly for patients who do not respond well to conventional treatments[1][5].

Q: What are the key drivers of the Auranofin market?

A: Key drivers include increasing awareness about autoimmune disorders, advancements in drug delivery systems, and governmental and non-governmental funding for chronic diseases and cancer research[1][4].

Q: Which regions are expected to show significant growth in the Auranofin market?

A: The Asia-Pacific region, particularly countries like China and India, is expected to show significant growth due to rapidly evolving healthcare systems and increasing patient awareness[1][4].

Q: What are the main challenges facing the Auranofin market?

A: The main challenges include side effects associated with the drug, regulatory hurdles, and competition from alternative treatments such as newer biologic DMARDs and biosimilars[4].

Q: What are the potential new therapeutic applications of Auranofin?

A: Auranofin has potential applications in treating certain cancers, parasitic infections, and as an antiviral agent, which could open new market segments[4][5].

References

  1. MarkWide Research: Auranofin market 2024-2032 | Size, Share, Growth.
  2. PubMed: The cost effectiveness of auranofin: results of a randomized clinical trial.
  3. Federal Trade Commission: Generic Drug Industry Dynamics.
  4. 360iResearch: Auranofin Market Size & Share 2025-2030.
  5. DrugBank Online: Auranofin: Uses, Interactions, Mechanism of Action.

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