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Last Updated: December 22, 2024

TANDEARIL Drug Patent Profile


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When do Tandearil patents expire, and what generic alternatives are available?

Tandearil is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in TANDEARIL is oxyphenbutazone. There is one drug master file entry for this compound. Additional details are available on the oxyphenbutazone profile page.

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Summary for TANDEARIL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 57
Patent Applications: 5,522
DailyMed Link:TANDEARIL at DailyMed
Drug patent expirations by year for TANDEARIL

US Patents and Regulatory Information for TANDEARIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis TANDEARIL oxyphenbutazone TABLET;ORAL 012542-004 Sep 3, 1982 DISCN No 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

TANDEARIL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Tandearil

Introduction

Tandearil, an anti-arthritic drug, was once a part of the pharmaceutical portfolio of Ciba-Geigy, a company that later merged with Sandoz to form Novartis. The drug's history is marked by significant controversies, regulatory issues, and ultimately, a decline in its market presence.

Historical Context

Tandearil was introduced as a treatment for arthritic conditions, but its use was soon marred by serious health concerns. In the early 1980s, it was discovered that Tandearil, along with another Ciba-Geigy drug called Butazolidin, had been responsible for several thousand deaths and serious injuries globally[2].

Regulatory Challenges

Following the revelation of the drug's harmful effects, Ciba-Geigy faced intense scrutiny. An internal document leaked to the press in 1983 highlighted the risks associated with Tandearil and Butazolidin. As a result, health officials were advised to restrict the use of these drugs to acute conditions only. Despite this, the company continued to distribute Butazolidin after modifying its packaging, while Tandearil's production was eventually ceased under pressure from health advocacy groups such as Health Action International[2].

Market Impact

The cessation of Tandearil's production had a direct impact on its market presence. The drug, which had once been prescribed for arthritic conditions, was no longer available, leading to a complete loss of revenue from this product line. This not only affected Ciba-Geigy's financials but also damaged the company's reputation due to the associated health risks and regulatory issues.

Financial Consequences

The financial trajectory of Tandearil was severely impacted by the regulatory and health concerns. The costs associated with compensating victims, legal settlements, and the loss of revenue from the drug's removal from the market were significant. These financial burdens contributed to the overall decline in the company's financial health related to this product.

Comparison with Other Pharmaceutical Products

Unlike blockbuster drugs that generate billions of dollars in revenue, such as AbbVie's Humira, Tandearil's financial performance was cut short due to its safety issues. The average cost of bringing a new drug to market is about $2.6 billion, and the failure of a drug like Tandearil can significantly impact a company's return on investment (ROI)[3].

Industry Trends and Lessons Learned

The case of Tandearil highlights the importance of rigorous testing and regulatory compliance in the pharmaceutical industry. The increasing cost of stricter regulatory hurdles and the potential for short exclusivity periods due to patent challenges or the introduction of generic competitors can significantly affect a drug's financial trajectory. Companies must strategically align their R&D investments to address unmet medical needs while ensuring the safety and efficacy of their products[3].

Patient and Physician Education

The Tandearil saga underscores the need for patient and physician education. Ensuring that both patients and healthcare providers are aware of the potential risks and benefits of medications can help prevent adverse outcomes. This is particularly relevant in the context of modern market trends, where patient activation and physician adoption are critical for the success of new drugs[4].

Conclusion

The story of Tandearil serves as a cautionary tale in the pharmaceutical industry. It emphasizes the critical importance of safety, regulatory compliance, and transparent communication with patients and healthcare providers. The financial consequences of failing to meet these standards can be severe, leading to significant losses and reputational damage.

Key Takeaways

  • Safety and Efficacy: Ensuring the safety and efficacy of drugs is paramount to their market success and the well-being of patients.
  • Regulatory Compliance: Adhering to regulatory standards is crucial to avoid legal and financial repercussions.
  • Transparency: Transparent communication with patients and healthcare providers is essential for building trust and preventing adverse outcomes.
  • Financial Impact: The failure of a drug due to safety concerns can have significant financial implications for pharmaceutical companies.
  • Industry Trends: The pharmaceutical industry is increasingly focused on addressing unmet medical needs while navigating complex regulatory and market dynamics.

FAQs

What was Tandearil used for?

Tandearil was used as an anti-arthritic medication.

Why was Tandearil removed from the market?

Tandearil was removed from the market due to its association with several thousand deaths and serious injuries globally.

What company produced Tandearil?

Tandearil was produced by Ciba-Geigy, which later merged with Sandoz to form Novartis.

How did the removal of Tandearil affect Ciba-Geigy financially?

The removal of Tandearil led to significant financial losses, including compensation for victims and legal settlements, which damaged the company's financial health.

What lessons can be learned from the Tandearil case?

The Tandearil case highlights the importance of rigorous testing, regulatory compliance, and transparent communication with patients and healthcare providers in the pharmaceutical industry.

Sources

  1. Federal Trade Commission - Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics[1].
  2. Corporate Research Project - Novartis: Corporate Rap Sheet[2].
  3. DrugBank Blog - Investment Trends in Pharmaceutical Research[3].
  4. IQVIA - Top 10 U.S. Market Access Trends for 2024[4].

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