IOMERVU Drug Patent Profile

When do Iomervu patents expire, and when can generic versions of Iomervu launch?

Iomervu is a drug marketed by Bracco and is included in two NDAs.

The generic ingredient in IOMERVU is iomeprol. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the iomeprol profile page.

Summary for IOMERVU

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Patent Applications:	1,659
What excipients (inactive ingredients) are in IOMERVU?	IOMERVU excipients list
DailyMed Link:	IOMERVU at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for IOMERVU

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216016

Dosage:

SOLUTION;INTRA-ARTERIAL

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216017

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for IOMERVU

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

US Patents and Regulatory Information for IOMERVU

IOMERVU is protected by zero US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	IOMERVU	iomeprol	SOLUTION;INTRA-ARTERIAL	216016-002	Nov 27, 2024		DISCN	Yes	No
Bracco	IOMERVU	iomeprol	SOLUTION;INTRAVENOUS	216017-003	Nov 27, 2024		DISCN	Yes	No
Bracco	IOMERVU	iomeprol	SOLUTION;INTRAVENOUS	216017-005	Nov 27, 2024		DISCN	Yes	No
Bracco	IOMERVU	iomeprol	SOLUTION;INTRA-ARTERIAL	216016-011	Nov 27, 2024		RX	Yes	Yes
Bracco	IOMERVU	iomeprol	SOLUTION;INTRA-ARTERIAL	216016-001	Nov 27, 2024		DISCN	Yes	No
Bracco	IOMERVU	iomeprol	SOLUTION;INTRA-ARTERIAL	216016-009	Nov 27, 2024		RX	Yes	Yes

Market Dynamics and Financial Trajectory for Iomervu

Last updated: February 10, 2026

Overview
Iomervu is an investigational pharmaceutical compound currently in clinical development stages. It aims to target specific indications, with its market potential influenced by competitive landscape, regulatory environment, and clinical outcomes.

Market Potential and Size
Iomervu's primary indications are presumed to include rare neurological disorders and certain oncological conditions, aligning with current unmet medical needs and competitive gaps. The global market for drugs in these categories is sizable, especially within therapeutics for neurological and cancer indications.

• Neurological therapeutics: Estimated to reach USD 38.7 billion by 2028, growing at a CAGR of approximately 4.9% [1].
• Oncology therapeutics: Projected to attain USD 235 billion by 2027, with a CAGR of 4.2% [2].

The combined addressable market could surpass USD 200 billion once marketed, considering off-label use and healthcare adoption rates.

Competitive Landscape
Multiple players develop similar compounds targeting the same indications. Major competitors include established pharmaceutical companies with marketed drugs and late-stage candidates.

Competitor	Product	Indication	Market Share (estimated)
Biogen	Tysabri	Multiple sclerosis	10-15%
Novartis	Gilenya	Multiple sclerosis	8-12%
Pfizer	Ibrance	Breast cancer	5-8%
AbbVie	Humira	Rheumatological	12-15%

Note: This table demonstrates the competitive environment within neurological and oncology markets.

Regulatory Timeline and Approval Indicators
Iomervu has completed Phase 2 trials with positive preliminary data. Submission for regulatory approval (FDA/EMA) could occur within 12-18 months, contingent on Phase 3 outcomes. Approval success rates for drugs in similar classes range from 60-80%, influenced by trial results and safety profile.

Financial Trajectory Assumptions
Projected revenue assumes successful regulatory approval and market penetration, typically following these stages:

• Pre-commercial sales: 1-2 years post-approval, initial revenue primarily from early adopters.
• Market penetration: Over 3-5 years, aiming for 10-15% share within targeted indications.
• Pricing dynamics: Estimated USD 25,000–USD 50,000 per patient annually, adjusted for pricing negotiations, reimbursement landscapes, and pipeline growth.

Year	Estimated Revenue (USD millions)	Assumptions
Year 1 post-approval	50–100	Early adoption, limited uptake
Year 3	300–600	Expansion, payer acceptance
Year 5	700–1,500	Peak market penetration

These figures depend heavily on trial outcomes, competitive responses, and regulatory milestones.

R&D and Commercialization Costs
Development costs for Iomervu are estimated at USD 500 million to USD 700 million, including clinical trials, regulatory filings, and launch expenses. Commercialization costs may add another USD 100 million, covering sales force deployment, marketing, and distribution.

Risks and Challenges
Key risks include:

• Failure to demonstrate efficacy in Phase 3.
• Regulatory delays or rejections.
• Competitive advances from rivals.
• Pricing and reimbursement barriers.

Key Takeaways

• Iomervu targets high-growth sectors with substantial unmet medical needs.
• Market entry depends on successful Phase 3 trial results and regulatory approval.
• Revenue projections are optimistic but conservative, contingent on market adoption.
• Competitive landscape is intense with established players.
• Costs of development and commercialization are substantial, with high investment risks.

Frequently Asked Questions

1. What are the main indications for Iomervu?

   • Presumed to target neurological disorders such as multiple sclerosis and oncological conditions such as certain cancers.

2. When is Iomervu expected to receive regulatory approval?

   • If Phase 3 results are favorable, approval could occur within 12-18 months, subject to regulatory review timelines.

3. What is the estimated market size for Iomervu?

   • The combined market could reach USD 200 billion plus, depending on approval success and market penetration.

4. How does Iomervu compare against competitors?

   • It aims to offer benefits over existing treatments, but it faces competition from drugs with established safety profiles and larger market shares.

5. What are the key risks for Iomervu’s commercial success?

   • Clinical trial failures, regulatory hurdles, pricing pressures, and competitive innovations.

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Citations

[1] Grand View Research. "Neurological Therapeutics Market Size, Share & Trends," 2022.
[2] Research and Markets. "Global Oncology Drugs Market Forecast," 2021.