BYNFEZIA PEN Drug Patent Profile

Which patents cover Bynfezia Pen, and when can generic versions of Bynfezia Pen launch?

Bynfezia Pen is a drug marketed by Sun Pharm and is included in one NDA. There are five 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:	5
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for BYNFEZIA PEN

BYNFEZIA PEN is protected by thirteen 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
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes			Y

International Patents for BYNFEZIA PEN

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112019023981
China	110678194
European Patent Office	3624829
South Korea	20200003923
Russian Federation	2019136628
World Intellectual Property Organization (WIPO)	2018211526

Investment Scenario and Fundamentals Analysis for BYNFEZIA PEN

Last updated: February 20, 2026

What is BYNFEZIA PEN?

BYNFEZIA PEN is a biosimilar developed for multiple indications of the originator product, Ferric Carboxymaltose (e.g., Injectafer). It is produced by Biocon Limited, an Indian biopharmaceutical firm. The product aims to address iron deficiency anemia, a widespread condition affecting diverse patient populations globally.

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Market Overview and Industry Context

Global Iron Deficiency Anemia Market

• Expected CAGR: 6% (2021-2028)
• Market size (2021): US$2.5 billion
• Drivers: Increasing prevalence, unmet needs in chronic kidney disease and gastrointestinal disorders, rising awareness

Existing Competition

Product Name	Originator	Approval Status	Market Share (2022)	Common Indications
Injectafer (Ferric Carboxymaltose)	Ferrer	Approved in US, EU	Dominates with ~60%	Iron deficiency anemia, CKD-related anemia
Ferinject (Ferinject)	Vifor/Fresenius	Approved in Europe	Significant presence	Similar, emphasizing Europe market

Biosimilar Entry Barriers

• Regulatory strictness, especially in US and EU
• Demonstrating biosimilarity through analytical, preclinical, and clinical data
• Market penetration challenges due to established brand loyalty and provider preferences

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Regulatory Landscape and Approval Process

Key Milestones for BYNFEZIA PEN

• Filing of regulatory submissions: 2022 (India, Russia)
• US FDA submission: Planned for 2024, following successful clinical trials
• European EMA submission: Anticipated in 2024

Regulatory Challenges

• US FDA: Biosimilar pathway under the 351(k) pathway requires comprehensive data
• EU EMA: Similar approval processes, with emphasis on biosimilarity and safety profile

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Financial Considerations

Development and Commercialization Costs

• Estimated R&D investment for biosimilars: US$50-150 million
• Manufacturing scale-up: US$25 million
• Regulatory expenses: US$10-20 million

Pricing and Reimbursement

Region	Price Comparison (per vial, US$)	Reimbursement Status
US	Biosimilar: US$250-300	Payer negotiations ongoing
EU	US$200-250	Reimbursement varies by country

Potential Market Penetration

• Initial targeting of niche severe anemia markets
• Expansion into broader iron deficiency indications

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SWOT Analysis

Strengths	Weaknesses
Established player (Biocon)	Limited global market presence as a biosimilar developer
Patent expiry of originator products	Pending regulatory approvals in key markets

Opportunities	Threats
Growing anemia prevalence	Intense competition from other biosimilars and originators
Cost pressures favor biosimilars	Regulatory delays and market access hurdles

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Investment Outlook

Pros

• Rising demand for iron deficiency therapies
• Biocon’s existing infrastructure and pipeline experience
• Potential for high-margin revenues once approved

Cons

• Delays in US FDA and EMA approvals could impact timelines
• Competitive pressure from established biosimilars and originators
• Pricing erosion possibilities with increased biosimilar adoption

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Key Takeaways

• BYNFEZIA PEN targets a large, growing market but faces significant regulatory and market entry challenges.
• Its success depends on timely regulatory approvals in high-value markets and competitive pricing strategies.
• Financial outlook favorable if regulatory hurdles are cleared and market penetration is achieved swiftly.
• Investment should consider regulatory timelines, competition, and reimbursement landscape.

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FAQs

1. What are the primary markets for BYNFEZIA PEN?

India, Russia, and anticipated entry into the US and European markets.

2. How does BYNFEZIA PEN compare to its originator?

It aims to match efficacy and safety, with a lower price point, but regulatory approval is necessary to confirm biosimilarity.

3. What are the main challenges for biosimilars like BYNFEZIA PEN?

Regulatory approval, market access, and competition from established originator products and other biosimilars.

4. When is regulatory approval expected?

In India and Russia by 2023-2024; US and EU approvals are targeted for 2024 onward.

5. What is the potential revenue impact?

If approved and adopted, revenues could range from US$100-300 million annually within 3-5 years, assuming competitive pricing and market penetration.

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References

[1] MarketsandMarkets. (2022). Iron deficiency anemia market analysis.
[2] U.S. Food and Drug Administration. (2022). Biosimilar application pathway.
[3] European Medicines Agency. (2022). Biosimilar medicinal products.
[4] Biocon Limited. (2022). Annual report.
[5] EvaluatePharma. (2022). Biosimilar market forecasts.