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Last Updated: December 22, 2024

HEXA-BETALIN Drug Patent Profile


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When do Hexa-betalin patents expire, and when can generic versions of Hexa-betalin launch?

Hexa-betalin is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in HEXA-BETALIN is pyridoxine hydrochloride. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the pyridoxine hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Hexa-betalin

A generic version of HEXA-BETALIN was approved as pyridoxine hydrochloride by FRESENIUS KABI USA on December 31st, 1969.

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Summary for HEXA-BETALIN
Drug patent expirations by year for HEXA-BETALIN

US Patents and Regulatory Information for HEXA-BETALIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly HEXA-BETALIN pyridoxine hydrochloride INJECTABLE;INJECTION 080854-001 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

HEXA-BETALIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GLP-1 Drugs like HEXA-BETALIN

Introduction to GLP-1 Drugs

GLP-1 (Glucagon-Like Peptide-1) receptor agonists, such as HEXA-BETALIN, have revolutionized the treatment of diabetes and obesity. These drugs have shown significant efficacy in lowering blood sugar levels and promoting substantial weight loss, making them a focal point in the pharmaceutical industry.

Market Opportunity

The market for GLP-1 drugs is vast and growing rapidly. It is estimated that more than half of the U.S. adult population, or approximately 137 million people, are eligible for GLP-1 treatments. This includes 32 million people with diabetes, 87 million who are obese, and 18 million who are overweight with comorbidities such as high blood pressure or cholesterol[1].

Eligible Population

  • Diabetics: 32 million people in the U.S. alone.
  • Obese Individuals: 87 million people.
  • Overweight with Comorbidities: 18 million people.

Financial Projections

The financial potential of GLP-1 drugs is substantial. Estimates suggest a $100 billion to $150 billion per year opportunity in the U.S. alone, assuming that 60% of diabetics and 30% of other eligible obese patients are treated with these drugs at a cost of $2,000 to $3,000 per year[1].

Current Pricing

  • List Price: $12,000 to $16,000 per year.
  • Insurance Discounts: Around $6,000 per year after negotiated discounts and rebates.
  • Future Pricing: Expected to drop to around $3,000 per year as access grows and competition increases.

Growth Drivers

Several factors are driving the rapid growth of the GLP-1 market:

High Awareness and Demand

Obesity is not asymptomatic, and patients are highly motivated to seek treatment. High awareness and the eagerness of patients to address their condition are key drivers of this market[1].

Rapid Market Penetration

Unlike some medications that take decades to reach peak penetration, obesity treatments are expected to scale more quickly due to the urgent need for effective solutions.

Clinical Efficacy

GLP-1 drugs have been shown to reduce weight by 15% to 20% with few major side effects or safety concerns, making them highly attractive to both patients and healthcare providers[1].

Investment Landscape

Investing in pharmaceutical research and development, particularly in the GLP-1 segment, comes with significant challenges but also substantial potential rewards.

Development Costs and Timeline

The average cost of bringing a new drug to market is about $2.6 billion, with a development timeline spanning 10 to 15 years. The probability of success for a drug candidate entering clinical trials is only around 10%, highlighting the substantial risks involved[3].

Potential Rewards

Successful drugs can generate large revenue streams. For example, AbbVie's Humira generated over $20 billion in annual revenue at its peak before losing patent exclusivity in 2023. GLP-1 drugs, with their dual efficacy in diabetes and obesity, are poised to capture a significant share of the market[3].

Regulatory and Market Dynamics

Regulatory Hurdles

The pharmaceutical industry faces increasing regulatory hurdles, which can impact the development and approval process of new drugs. However, the high demand for effective obesity and diabetes treatments has driven regulatory bodies to expedite approvals for promising candidates[3].

Market Competition

As more companies enter the GLP-1 market, competition is expected to increase. This competition could lead to lower prices and improved access to these drugs, further expanding their market penetration[1].

Global Market Potential

The global pharmaceutical market, projected to exceed $1.4 trillion by 2028, presents a vast opportunity for GLP-1 drugs. The escalating global burden of chronic diseases, such as diabetes and obesity, fuels this growth[3].

Oncology and Cardiovascular Markets

While GLP-1 drugs are primarily focused on diabetes and obesity, the broader pharmaceutical market includes significant opportunities in oncology and cardiovascular diseases. These areas also drive innovation and investment, contributing to the overall growth of the pharmaceutical sector[3].

Precision Medicine and Future Trends

Genomic Analysis

Precision medicine, leveraging genomic sequencing and molecular profiling, is becoming increasingly important. This approach can optimize treatment efficacy and minimize adverse events, potentially enhancing the effectiveness of GLP-1 drugs and other pharmaceuticals[3].

Next-Generation Therapies

Next-generation sequencing technologies have made genomic analysis faster and more affordable. This advancement is crucial for identifying disease-associated mutations and guiding treatment decisions, which could further enhance the market for targeted therapies like GLP-1 drugs.

Key Takeaways

  • Market Size: The U.S. market for GLP-1 drugs is estimated to be $100 billion to $150 billion per year.
  • Eligible Population: Over 137 million people in the U.S. are eligible for GLP-1 treatments.
  • Clinical Efficacy: GLP-1 drugs reduce weight by 15% to 20% with few major side effects.
  • Future Pricing: Expected to drop to around $3,000 per year as access grows.
  • Global Potential: Part of a broader pharmaceutical market projected to exceed $1.4 trillion by 2028.

FAQs

What is the estimated market size for GLP-1 drugs in the U.S.?

The estimated market size for GLP-1 drugs in the U.S. is $100 billion to $150 billion per year.

How many people in the U.S. are eligible for GLP-1 treatments?

Over 137 million people in the U.S. are eligible for GLP-1 treatments, including those with diabetes, obesity, and other comorbidities.

What is the current pricing for GLP-1 drugs like HEXA-BETALIN?

The current list price for GLP-1 drugs is $12,000 to $16,000 per year, but insurance companies pay around $6,000 per year after discounts and rebates.

What are the expected future prices for GLP-1 drugs?

The net price of GLP-1 drugs is expected to come down over time, potentially reaching around $3,000 per year as access grows and competition increases.

How do GLP-1 drugs impact weight loss and diabetes management?

GLP-1 drugs have been shown to reduce weight by 15% to 20% and effectively lower blood sugar levels, making them highly effective for both obesity and diabetes management.

Sources

  1. Baron Capital Group: A Multi-Billion-Dollar Drug Market | Baron Funds
  2. United States Securities and Exchange Commission: [PDF] united states securities and exchange commission
  3. DrugBank Blog: Investment Trends in Pharmaceutical Research - DrugBank Blog
  4. Towards Healthcare: Pediatric Drugs Market Size Envisioned at USD 363.86 Billion by 2032

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