IVRA Drug Patent Profile

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

Ivra is a drug marketed by Apotex and is included in one NDA. There is one patent protecting this drug.

This drug has one patent family member in one country.

The generic ingredient in IVRA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ivra

A generic version of IVRA was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9^th, 2009.

Summary for IVRA

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

Pharmacology for IVRA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

US Patents and Regulatory Information for IVRA

IVRA is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	IVRA	melphalan hydrochloride	SOLUTION;INTRAVENOUS	217110-001	Aug 18, 2023		RX	Yes	Yes			Y

International Patents for IVRA

See the table below for patents covering IVRA around the world.

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2017002030

Supplementary Protection Certificates for IVRA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	2290047-6	Sweden		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	202240050	Slovenia		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; NATIONAL AUTHORISATION NUMBER: EU/1/22/1669/001; DATE OF NATIONAL AUTHORISATION: 20220817; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2701720	23C1000	France		PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720	SPC/GB23/004	United Kingdom		PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTERED: UK EU/1/22/1669/001(NI) 20220818; UK MORE ON HISTORY TAB 20220818
2701720	122023000007	Germany		PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817

Market Dynamics and Financial Trajectory for IVRA

Last updated: February 19, 2026

What is the current market landscape for Intravenous Regional Anesthesia (IVRA)?

IVRA, also known as Bier block anesthesia, is a targeted anesthetic technique primarily used for surgeries on the extremities. The global anesthesia market, valued at approximately $27 billion in 2022, includes IVRA as a niche segment. The segment's growth depends heavily on regional healthcare practices, developments in anesthesia agents, and procedural volume of limb surgeries.

How is the adoption of IVRA evolving globally?

The adoption of IVRA is constrained by several factors:

• Limited indications: Most effective for short procedures involving limbs.
• Operator expertise: Requires specific skills to minimize complications.
• Alternative techniques: Local infiltration anesthesia and general anesthesia are often preferred due to broader applicability.

However, growing preference for minimally invasive procedures and outpatient surgery promotes IVRA use in certain regions.

What are the key technical and regulatory drivers influencing IVRA?

• Advances in local anesthetic agents: Development of agents with longer duration and better safety profiles.
• Regional guidelines: The American Society of Anesthesiologists (ASA) guidelines support regional anesthesia techniques, including IVRA, as safe options.
• Drug approvals: Lyrica (pregabalin) and similar agents facilitate adjunctive use, expanding indications.

Regulatory approval processes remain relatively straightforward for established agents but vary for proprietary formulations or procedural devices.

Who are the primary commercial players and their strategies?

• Hospira (now part of Pfizer): Historically supplied local anesthetics suitable for IVRA.
• Teleflex: Manufactures tourniquet systems essential for IVRA.
• Uncertain proprietary development pipeline: No major companies focusing exclusively on IVRA drugs or devices.

R&D focus centers on optimizing anesthetic formulations, tourniquet systems, and procedural protocols.

What financial trends are evident in IVRA-specific treatments?

• The total local anesthesia market is projected to grow from $6.3 billion in 2022 to $8.0 billion by 2030, at a CAGR of approximately 2.8%.[1]
• IVRA accounts for about 5-8% of local anesthesia procedures, limiting direct revenue but providing a niche for innovation.
• Investment in devices like tourniquets and infusion kits is increasing, driven by hospital demand for safer, reliable regional anesthesia methods.

What regulatory outlook begins to shape future commercial prospects?

• US Food and Drug Administration (FDA) approval for new anesthetic formulations could expand IVRA applications.
• The European Medicines Agency (EMA) supports regional anesthetic technologies with updated guidelines.
• Product-specific approvals are critical for market entry of proprietary IVRA drugs.

How does competitive positioning influence future prospects?

• Limited competition exists for proprietary IVRA drugs; most professionals use off-label anesthetics.
• Companies focusing on device innovation, such as smart tourniquet systems with safety features, are gaining market share.
• Emerging biosimilar and generic formulations may lower costs and expand accessibility.

What is the outlook regarding revenue potential and growth?

While direct revenue from IVRA drugs remains niche, growth stems from:

• Increased procedural volumes due to rising outpatient surgeries.
• Innovations improving safety and ease-of-use.
• Geographic expansion into emerging markets pursuing minimally invasive techniques.

Overall, IVRA will continue as a specialized segment within the regional anesthesia domain, with incremental growth driven by procedural volume and procedural safety innovations.

Key Takeaways

• The IVRA market is a niche within the broader local anesthesia segment, with limited direct drug revenues but opportunities in device markets.
• Growth factors include increased outpatient limb surgeries, advances in anesthetic formulations, and safety innovations.
• Regulatory environments in key regions support regional anesthesia techniques, aiding promising approvals.
• Competition mainly involves devices and procedural protocols rather than proprietary drugs.
• Future growth hinges on technological innovation, regulatory approvals, and expanding procedural applications.

FAQs

1. What is the primary use of IVRA?
It is used for anesthesia during surgeries on the limbs, particularly the hand, forearm, foot, and lower leg, where a quick, localized effect is needed.

2. Which regions are leading in IVRA adoption?
North America and Europe are the primary markets, supported by established healthcare infrastructure and procedural volume.

3. Are there proprietary drugs specifically developed for IVRA?
Currently, most anesthetics used in IVRA are off-label, with no widely marketed drugs exclusive to IVRA indications.

4. How does device innovation influence the IVRA market?
Safe, reliable tourniquet systems and infusion devices enhance procedural outcomes, driving adoption and market growth.

5. What are the key risks to future market growth?
Established alternatives, procedural expertise requirements, regulatory hurdles for new drugs, and competition from other regional anesthesia techniques.

References

[1] Grand View Research. (2023). Local Anesthesia Market Size, Share & Trends. Available at: https://www.grandviewresearch.com/industry-analysis/local-anesthesia-market