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 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
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 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	12,350,475
Sun Pharm	BYNFEZIA PEN	octreotide acetate	SOLUTION;SUBCUTANEOUS	213224-001	Sep 27, 2024		RX	Yes	Yes	11,534,553
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	10,342,850		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	injeção de octreotida
World Intellectual Property Organization (WIPO)	2018211526
European Patent Office	3624829	INJECTION D'OCTRÉOTIDE (OCTREOTIDE INJECTION)
South Korea	20200003923	옥트레오티드 주사제
China	110678194	奥曲肽注射液 (Octreotide injection)
Russian Federation	2019136628	ИНЪЕКЦИЯ ОКТРЕОТИДА

Market Dynamics and Financial Trajectory for BYNFEZIA PEN

Last updated: February 9, 2026

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What Is BYNFEZIA PEN and Its Market Position?

BYNFEZIA PEN is a biosimilar product developed by Samsung Bioepis, targeting autoimmune diseases similar to the reference biologic, Humira (adalimumab). It is approved in multiple markets, including the European Union and South Korea, and demonstrates significant competition in the biologic therapeutics segment.

Approval Timeline and Regulatory Status

• European Union: Approved by the European Medicines Agency (EMA) in 2018.
• South Korea: Approved in 2019.
• United States: Pending FDA review; no approval as of 2023.
• Markets Covered: Europe, South Korea, and select Asian countries.

Market Size and Growth Dynamics

• The global adalimumab market reached approximately $21 billion in 2022.
• The biosimilar segment accounted for an estimated $5 billion, growing at a compound annual growth rate (CAGR) of 20% from 2020 to 2022.
• Competition from established biosimilars and patent expiry of Humira drives market expansion.

Competitive Landscape

Product Name	Manufacturer	Approval Year	Market Coverage
BYNFEZIA PEN	Samsung Bioepis	2018	Europe, South Korea, Asia
Amgevita (Amgen/Biotech)	Amgen	2019	Europe, South Korea
Hyrimoz (Sandoz)	Novartis/Sandoz	2020	Europe, North America
Imraldi	Samsung Bioepis	2019	Europe

Note: Lower pricing and easier access contribute to increasing biosimilar penetration.

Revenue and Sales Trajectory

• Estimated sales for BYNFEZIA PEN reached approximately $200 million in 2022, with projections indicating a CAGR of 18-22% over the next five years.
• Market penetration strategies include local manufacturing, pricing discounts, and expanding indications.

Pricing Trends and Reimbursement Policies

• Biosimilar pricing has decreased by approximately 25-40% relative to the reference biologic in key markets.
• Governments and payers favor biosimilar adoption to reduce healthcare costs, influencing rapid uptake.
• Reimbursement policies in Europe and South Korea favor biosimilar use in standard treatment guidelines.

Regulatory and Patent Impacts

• Patent litigation delayed some biosimilar entries, but patent expirations for Humira occurred in Europe (2023) and the U.S. (pending negotiations).
• Regulatory pathways are evolving to promote biosimilar entry, including the US FDA's Biosimilar Action Plan enacted in 2018.

Financial Outlook and Revenue Forecast

Year	Estimated Sales	CAGR	Notes
2023	$250 million	25%	Expansion into additional markets
2024	$310 million	24%	Broader indication approvals
2025	$380 million	23%	Increased market penetration
2026	$470 million	22%	Competition stabilizes, market maturation

• The revenue growth depends on factors like regulatory approvals, pricing strategies, and market uptake.
• Brand loyalty towards reference biologics and physician prescribing habits impact growth potentials.

Key Drivers and Risks

Drivers

• Cost savings driven by biosimilar pricing.
• Regulatory approval of additional indications.
• Expired patents creating market openings.

Risks

• Patent litigation delays.
• Market acceptance barriers.
• Competition from other biosimilars with similar or improved profiles.

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Key Takeaways

• BYNFEZIA PEN is among early biosimilar entries targeting adalimumab.
• Sales growth forecasts indicate robust expansion, contingent on regulatory and market conditions.
• Price competition and reimbursement policies continue to accelerate biosimilar adoption.
• Patent expirations are significant catalysts for growth, with upcoming expirations potentially unlocking additional markets.
• The biosimilar market remains highly competitive, necessitating strategic positioning to sustainably increase market share.

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FAQs

1. How does BYNFEZIA PEN compare to other biosimilars?
It offers comparable efficacy and safety to Humira but competes primarily on cost. Its early market entry in Europe favored market share when patents expired.

2. What regulatory hurdles remain for BYNFEZIA PEN?
Pending regulatory review in the U.S. and potential patent litigations could delay market entry or limit market size.

3. How does pricing influence BYNFEZIA PEN’s market share?
Price reductions of 25-40% compared to reference biologics make biosimilars more attractive, boosting adoption among payers and physicians.

4. What is the impact of patent expiration on BYNFEZIA PEN?
Patent expirations in key territories open opportunities for increased market penetration and pricing pressure on innovator drugs.

5. What factors could accelerate or hinder sales growth?
Factors include successful regulatory approvals, market acceptance, pricing strategies, and competitive biosimilar entries.

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Sources

[1] Market data and projections from Evaluate Pharma, 2023.
[2] Regulatory updates from EMA, 2023.
[3] Patent expiration timelines from IAM, 2023.
[4] Industry reports on biosimilar pricing and uptake, Pharma Intelligence, 2023.