BYNFEZIA PEN Drug Patent Profile

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

Bynfezia Pen is a drug marketed by Sun Pharm and is included in one NDA. There are four patents protecting this drug.

This drug has six patent family members in six countries.

The generic ingredient in BYNFEZIA PEN is octreotide acetate. There are twenty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Bynfezia Pen

A generic version of BYNFEZIA PEN was approved as octreotide acetate by WEST-WARD PHARMS INT on April 8^th, 2005.

Summary for BYNFEZIA PEN

International Patents:	6
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in BYNFEZIA PEN?	BYNFEZIA PEN excipients list
DailyMed Link:	BYNFEZIA PEN at DailyMed

Pharmacology for BYNFEZIA PEN

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

US Patents and Regulatory Information for BYNFEZIA PEN

BYNFEZIA PEN is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	11,246,991
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	11,052,196
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	11,534,553

International Patents for BYNFEZIA PEN

See the table below for patents covering BYNFEZIA PEN around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3624829	INJECTION D'OCTRÉOTIDE (OCTREOTIDE INJECTION)
China	110678194	奥曲肽注射液 (Octreotide injection)
World Intellectual Property Organization (WIPO)	2018211526

Market Dynamics and Financial Trajectory for Bynfezia Pen

Introduction to Bynfezia Pen

Bynfezia Pen, a formulation of exenatide, is a glucagon-like peptide-1 (GLP-1) receptor agonist used primarily in the treatment of type 2 diabetes. It is administered via a pre-filled pen, making it a convenient option for patients.

Market Opportunity and Growth

The global market for peptide drugs, including those like Bynfezia Pen, is experiencing significant growth driven by several factors:

• Increasing Prevalence of Chronic Conditions: The rise in diabetes and other metabolic disorders is a key driver for the demand of GLP-1 receptor agonists like Bynfezia Pen[1].
• Advancements in Technology: Novel technologies and platforms developed by pharmaceutical companies are expanding the portfolio of therapeutic peptides, providing diverse market opportunities[1].
• Research and Development: The increasing research on the therapeutic use of peptides and the development of new drugs are expected to further boost the market[1].

Clinical and Commercial Insights

• Clinical Trials: While specific data on Bynfezia Pen's clinical trials is not detailed, the broader category of peptide cancer drugs and metabolic disorder treatments involves extensive clinical trials. Over 200 peptide drugs are in various stages of clinical trials, indicating a robust pipeline of potential treatments[1].
• Market Size: The global peptide therapeutic market, which includes drugs like Bynfezia Pen, is projected to grow significantly from 2022 to 2029. This growth is anticipated to be driven by the increasing demand for effective and novel therapies[1].

Pricing and Dosage

• Dosage: Bynfezia Pen is typically administered in a specific dosage regimen. For example, the mean dose for the first two weeks and subsequent weeks is carefully defined to ensure efficacy and safety[1].
• Pricing: The cost of Bynfezia Pen can vary based on the supply and dosage. As of June 2023, the price for a 2.8ml supply and the price per ml of the 2500mcg/ml subcutaneous solution have been documented. These prices highlight the financial considerations for both patients and healthcare providers[1].

Financial Trajectory

• Sales and Revenue: Specialty medications, including those like Bynfezia Pen, are among the top categories in terms of healthcare expenditure. For instance, the average cost per 30-day supply for similar specialty medications can range from $9,000 to over $16,000 annually per utilizer[2].
• Market Share: The market share of Bynfezia Pen within the GLP-1 receptor agonist segment is influenced by its efficacy, safety profile, and patient compliance. The drug's convenience, administered via a pre-filled pen, can contribute to its market share[3].

Competitive Landscape

• Competitors: Bynfezia Pen competes with other GLP-1 receptor agonists such as Novo Nordisk's Victoza and AstraZeneca's Bydureon. The competitive landscape is dynamic, with each drug having its own strengths and weaknesses in terms of efficacy, safety, and patient preference[3].
• Market Share Analysis: The market share of Bynfezia Pen is part of a larger analysis that includes other peptide therapeutics. The global peptide therapeutic market is segmented by drug type, indication, and geography, providing a comprehensive view of the competitive landscape[1].

Patient and Healthcare Provider Awareness

• Awareness and Adoption: Awareness among healthcare professionals and patients about the significant adverse events associated with conventional treatments can lead to greater adoption of peptide-based therapeutics like Bynfezia Pen. This awareness is a critical factor in the drug's market dynamics[1].

Geographical Distribution

• Global Reach: The market for peptide therapeutics, including Bynfezia Pen, is global. North America and Europe are significant markets due to high healthcare expenditure and advanced medical facilities. However, the Asia-Pacific region is expected to grow significantly due to increasing healthcare expenditure and technological advancements[4].

Regulatory and Patent Insights

• Patent Expiration: The patent status of Bynfezia Pen is crucial for its market trajectory. Patent expiration can lead to the entry of generic versions, affecting the drug's market share and pricing. For example, the patent issue and expiration years for similar drugs like Firmagon are closely monitored[1].

Conclusion

The market dynamics and financial trajectory of Bynfezia Pen are influenced by a combination of factors including the increasing prevalence of chronic conditions, advancements in technology, and the competitive landscape within the GLP-1 receptor agonist market.

Key Takeaways

• Growing Market: The global peptide therapeutic market, including drugs like Bynfezia Pen, is expected to grow significantly.
• Clinical and Commercial Insights: Extensive clinical trials and commercial success of similar peptide drugs indicate a robust market.
• Pricing and Dosage: Careful pricing and dosage strategies are essential for the drug's market success.
• Competitive Landscape: Bynfezia Pen competes with other GLP-1 receptor agonists, and its market share is influenced by its efficacy and patient compliance.
• Geographical Distribution: The drug has a global reach, with significant markets in North America, Europe, and the Asia-Pacific region.

FAQs

1. What is Bynfezia Pen used for?

   • Bynfezia Pen is used primarily in the treatment of type 2 diabetes as a glucagon-like peptide-1 (GLP-1) receptor agonist.

2. How is Bynfezia Pen administered?

   • Bynfezia Pen is administered via a pre-filled pen, making it a convenient option for patients.

3. What drives the market growth for Bynfezia Pen?

   • The market growth is driven by the increasing prevalence of chronic conditions, advancements in technology, and the increasing demand for effective and novel therapies.

4. How does Bynfezia Pen compare to other GLP-1 receptor agonists?

   • Bynfezia Pen competes with other GLP-1 receptor agonists such as Victoza and Bydureon, with its market share influenced by its efficacy, safety profile, and patient compliance.

5. What are the key geographical markets for Bynfezia Pen?

   • The key geographical markets include North America, Europe, and the Asia-Pacific region, with the latter expected to grow significantly due to increasing healthcare expenditure and technological advancements.

Sources

1. Global Peptide Cancer Drug Market, Dosage, Price, Sales and ...
   • ResearchAndMarkets.com
2. Retiree Plan Specialty Prior Authorization Opportunity
   • drb.alaska.gov
3. Retiree Health Plan Advisory Board Meeting Agenda
   • drb.alaska.gov
4. Global Gigantism Drugs Market - Industry Trends and Forecast to 2028
   • Data Bridge Market Research

Last updated: 2024-12-18