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Last Updated: December 22, 2024

ORINASE Drug Patent Profile


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

Orinase is a drug marketed by Pharmacia And Upjohn and is included in two NDAs.

The generic ingredient in ORINASE 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
Drug patent expirations by year for ORINASE
Recent Clinical Trials for ORINASE

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

SponsorPhase
Corcept TherapeuticsPhase 1
Daiichi Sankyo, Inc.Phase 1
NovartisPhase 2

See all ORINASE clinical trials

US Patents and Regulatory Information for ORINASE

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 tolbutamide TABLET;ORAL 010670-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Pharmacia And Upjohn ORINASE tolbutamide TABLET;ORAL 010670-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
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 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Orinase (Tolbutamide)

Introduction to Orinase (Tolbutamide)

Orinase, commonly known by its generic name tolbutamide, is an oral anti-diabetic drug used to treat type 2 diabetes. It belongs to the class of sulfonylureas, which work by stimulating the pancreas to release more insulin.

Market Size and Growth

The sulfonylureas market, which includes tolbutamide, is projected to grow significantly over the next few years. As of 2024, the sulfonylureas market is estimated to be valued at USD 9.98 billion and is expected to reach USD 11.32 billion by 2029, growing at a CAGR of 3.12% during the forecast period[1].

Regional Market Dynamics

North America: Largest Market Share

North America currently holds the largest market share in the sulfonylureas market, driven by a high prevalence of diabetes and well-established healthcare infrastructure[1].

Middle East and Africa: Fastest Growing Region

The Middle East and Africa region is expected to witness the highest CAGR over the forecast period. This growth is attributed to the alarming increase in the prevalence of diabetes in this region, with 73 million adults living with diabetes in the IDF MENA Region in 2021, projected to rise to 95 million by 2030[1].

Impact of COVID-19

The COVID-19 pandemic has had a substantial impact on the sulfonylureas market. The increased prevalence of diabetes among patients hospitalized with COVID-19 and the recognition of the importance of glycemic control in improving outcomes have boosted the demand for oral anti-diabetic drugs like tolbutamide. Patients with diabetes have a weaker immune system, making them more susceptible to severe COVID-19 complications, thus highlighting the critical role of sulfonylureas in managing blood sugar levels[1].

Key Players and Market Competition

The sulfonylureas market is dominated by several major players, including Sanofi Aventis, Pfizer Inc., Merck & Co., Inc., Torrent Pharma, and Dr. Reddy's Laboratories. These companies play a significant role in driving market growth through their extensive product portfolios and strong distribution networks[1].

Manufacturing and Production Costs

The production of tolbutamide involves several key steps, including raw material procurement, chemical reactions, and quality control. A detailed analysis of the manufacturing process reveals that the cost of production is influenced by factors such as raw material requirements, utility costs, operating costs, and capital investments. Efficient production processes and technological advancements are crucial for optimizing costs and maintaining profit margins[4].

Financial Performance and Investment

Investors and stakeholders are keenly interested in the financial performance of the sulfonylureas market. The market's growth trajectory suggests a stable and increasing revenue stream. Companies operating in this market are expected to invest significantly in research and development to improve existing products and expand their product lines. For instance, the overall sulfonylureas market is expected to grow from USD 9.98 billion in 2024 to USD 11.32 billion by 2029, indicating a robust financial outlook[1].

Clinical and Therapeutic Use

Tolbutamide is used to treat high blood sugar levels caused by type 2 diabetes. It works by stimulating the release of insulin from the pancreas. Regular monitoring of blood sugar levels and periodic check-ups with healthcare providers are essential to ensure the medicine is working effectively and to manage any potential side effects[5].

Side Effects and Precautions

While tolbutamide is effective in managing type 2 diabetes, it can have several side effects, ranging from common issues like indigestion and stomach pain to less common but more serious conditions such as unexplained bleeding or bruising. It is crucial for patients to follow their healthcare provider's instructions carefully and report any adverse symptoms promptly[5].

Market Trends and Future Outlook

The market for sulfonylureas, including tolbutamide, is influenced by several trends:

  • Increasing Prevalence of Diabetes: The rising number of diabetes cases globally, particularly in regions like the Middle East and Africa, drives the demand for anti-diabetic medications.
  • Advancements in Healthcare: Improvements in healthcare infrastructure and the availability of advanced diagnostic tools contribute to the growth of the market.
  • Competition from New Therapies: The emergence of new obesity and diabetes treatments, such as those discussed by Morgan Stanley, may impact the market share of traditional sulfonylureas. However, these new treatments also highlight the broader healthcare landscape and the potential for sulfonylureas to remain a vital component of diabetes management[1][3].

Impact of Related Health Conditions

Obesity, which is closely linked to type 2 diabetes, is a significant factor influencing the market dynamics of sulfonylureas. The growing market for obesity drugs, expected to reach $105 billion by 2030, underscores the interconnected nature of these health conditions. As obesity rates increase, so does the demand for anti-diabetic medications like tolbutamide[3].

Conclusion

The market for Orinase (tolbutamide) is part of a larger and growing sulfonylureas market, driven by increasing diabetes prevalence and the need for effective glycemic control. With a projected market size of USD 11.32 billion by 2029 and a CAGR of 3.12%, the financial trajectory for tolbutamide and similar drugs appears robust. However, the market must navigate evolving healthcare trends, including the rise of new obesity and diabetes treatments.

Key Takeaways

  • The sulfonylureas market, including tolbutamide, is expected to grow from USD 9.98 billion in 2024 to USD 11.32 billion by 2029.
  • The Middle East and Africa region is the fastest-growing market for sulfonylureas.
  • COVID-19 has highlighted the importance of glycemic control, boosting demand for sulfonylureas.
  • Major players like Sanofi Aventis and Pfizer Inc. dominate the market.
  • Efficient production processes and technological advancements are crucial for maintaining profit margins.
  • The market is influenced by trends in diabetes prevalence, healthcare advancements, and the emergence of new therapies.

FAQs

1. What is the current market size of the sulfonylureas market? The sulfonylureas market size is expected to reach USD 9.98 billion in 2024[1].

2. Which region is expected to grow the fastest in the sulfonylureas market? The Middle East and Africa region is expected to witness the highest CAGR over the forecast period[1].

3. How does COVID-19 impact the sulfonylureas market? The COVID-19 pandemic has increased the demand for sulfonylureas due to the importance of glycemic control in patients with COVID-19[1].

4. What are the common side effects of tolbutamide? Common side effects include indigestion, stomach pain, and passing of gas. Less common side effects can include flushing or redness of the skin and unusually warm skin[5].

5. Who are the major players in the sulfonylureas market? Major players include Sanofi Aventis, Pfizer Inc., Merck & Co., Inc., Torrent Pharma, and Dr. Reddy's Laboratories[1].

Sources

  1. Mordor Intelligence: Sulfonylureas Market - Share, Size & Growth.
  2. Frontiers in Endocrinology: Cisapride induced hypoglycemia via the KCNH6 potassium channel.
  3. Morgan Stanley: Scaling Up the Impact of Obesity Drugs.
  4. Expert Market Research: Tolbutamide (Orinase) Manufacturing Plant Project Report 2024.
  5. Mayo Clinic: Tolbutamide (oral route) - Mayo Clinic.

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