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Last Updated: December 22, 2024

ORINASE DIAGNOSTIC Drug Patent Profile


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When do Orinase Diagnostic patents expire, and when can generic versions of Orinase Diagnostic launch?

Orinase Diagnostic is a drug marketed by Pharmacia And Upjohn and is included in one NDA.

The generic ingredient in ORINASE DIAGNOSTIC is tolbutamide sodium. There are fifteen drug master file entries for this compound. Additional details are available on the tolbutamide sodium profile page.

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Summary for ORINASE DIAGNOSTIC
Drug patent expirations by year for ORINASE DIAGNOSTIC

US Patents and Regulatory Information for ORINASE DIAGNOSTIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacia And Upjohn ORINASE DIAGNOSTIC tolbutamide sodium INJECTABLE;INJECTION 012095-001 Approved Prior to Jan 1, 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

ORINASE DIAGNOSTIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Orinase Diagnostic

Introduction

Orinase Diagnostic, a product of the drug tolbutamide, played a significant role in the management and diagnosis of type 2 diabetes, particularly during the mid-20th century. This article will delve into the market dynamics and financial trajectory of Orinase Diagnostic, highlighting its rise, impact, and eventual decline.

Historical Context of Orinase

Tolbutamide, marketed as Orinase, was one of the first oral hypoglycemic agents introduced in the 1950s for the management of type 2 diabetes. Initially, it was seen as a breakthrough in treating diabetes without the need for insulin injections[5].

Market Expansion and Diagnostic Use

In the early 1960s, Orinase Diagnostic was introduced as a tool to detect prediabetes. This innovation expanded the market for Orinase beyond just treating diagnosed diabetics. The diagnostic test involved administering Orinase along with cortisone in a stress test to identify individuals with abnormal glucose metabolism, indicating prediabetes. This strategy not only helped in diagnosing a previously hidden patient population but also created a new market segment for the treatment of prediabetes[5].

Market Dynamics

Increased Demand

The introduction of Orinase Diagnostic led to a significant increase in demand for the drug. As blood sugar testing became more widespread, more people were identified as being at risk for diabetes, creating a larger potential market for Orinase. This expansion was fueled by public health campaigns that highlighted the importance of early diagnosis and treatment of diabetes[5].

Competitive Landscape

During the 1960s, Orinase was part of a new class of drugs aimed at managing chronic conditions like diabetes, hypertension, and hypercholesterolemia. The competitive landscape was relatively less crowded compared to today, allowing Orinase to capture a substantial market share. However, the development of follow-on drugs, as seen in other pharmaceutical classes, would eventually increase competition[4].

Pricing and Affordability

The affordability of Orinase Diagnostic was a critical factor in its market success. As with many pharmaceuticals, the pricing strategy was balanced to ensure profitability while remaining accessible to patients. However, the long-term sustainability of the diagnostic use was also dependent on the overall healthcare financing and insurance coverage available at the time[2].

Financial Trajectory

Initial Success

The introduction of Orinase Diagnostic led to a significant financial boost for its manufacturer, Upjohn. The drug's dual role as both a therapeutic agent and a diagnostic tool increased its market value and revenue. By 1962, Orinase Diagnostic was a key component of the Orinase product line, contributing substantially to the company's financial performance[5].

Peak and Decline

By the late 1960s, prediabetes had become a diagnosable and treatable condition, which further expanded the market for Orinase. However, as more diagnostic tools and treatments became available, the need for Orinase Diagnostic as a separate entity diminished. The drug began to fall out of favor in the early 1970s due to reports of adverse effects in asymptomatic prediabetics on long-term regimens of Orinase. This led to a decline in its financial performance and eventual withdrawal of Orinase Diagnostic from the market[5].

Impact on the Pharmaceutical Industry

Innovation and Market Expansion

Orinase Diagnostic exemplified how innovative diagnostic tools could expand the market for therapeutic drugs. This approach has been replicated in various pharmaceutical sectors, where diagnostic tests are used to identify potential patients and create new market opportunities[1].

Regulatory and Safety Considerations

The decline of Orinase Diagnostic also highlighted the importance of regulatory oversight and safety monitoring. The adverse effects reported in the early 1970s underscored the need for rigorous clinical trials and post-marketing surveillance to ensure the safety and efficacy of pharmaceutical products[5].

Key Takeaways

  • Market Expansion: Orinase Diagnostic significantly expanded the market for tolbutamide by identifying and treating prediabetic patients.
  • Financial Success: The drug's dual role as a therapeutic and diagnostic agent led to substantial financial gains for its manufacturer.
  • Decline: The eventual decline was due to adverse effects and the development of more advanced diagnostic and therapeutic options.
  • Industry Impact: Orinase Diagnostic set a precedent for using diagnostic tools to expand pharmaceutical markets, while also emphasizing the importance of safety and regulatory compliance.

FAQs

What was the primary use of Orinase Diagnostic?

Orinase Diagnostic was used to detect prediabetes through a stress test involving the administration of Orinase along with cortisone.

How did Orinase Diagnostic impact the market for tolbutamide?

It expanded the market by identifying and treating prediabetic patients, thereby increasing the demand for tolbutamide.

Why did Orinase Diagnostic fall out of favor?

It fell out of favor due to reports of adverse effects in asymptomatic prediabetics on long-term regimens of Orinase.

What was the financial impact of Orinase Diagnostic on its manufacturer?

The drug significantly contributed to the financial performance of Upjohn during its peak, but its decline led to a reduction in revenue.

What lessons can be learned from the story of Orinase Diagnostic?

The importance of innovation, market expansion through diagnostic tools, and the critical need for safety and regulatory compliance in pharmaceutical products.

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