FOCINVEZ Drug Patent Profile

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

Focinvez is a drug marketed by Steriscience and is included in one NDA. There are two patents protecting this drug.

This drug has two patent family members in two countries.

The generic ingredient in FOCINVEZ is fosaprepitant dimeglumine. There are eleven drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the fosaprepitant dimeglumine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Focinvez

A generic version of FOCINVEZ was approved as fosaprepitant dimeglumine by FRESENIUS KABI USA on June 9^th, 2016.

Summary for FOCINVEZ

International Patents:	2
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
What excipients (inactive ingredients) are in FOCINVEZ?	FOCINVEZ excipients list
DailyMed Link:	FOCINVEZ at DailyMed

Pharmacology for FOCINVEZ

Drug Class	Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

US Patents and Regulatory Information for FOCINVEZ

FOCINVEZ is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Steriscience	FOCINVEZ	fosaprepitant dimeglumine	SOLUTION;INTRAVENOUS	216686-001	Aug 22, 2023		RX	Yes	Yes			Y
Steriscience	FOCINVEZ	fosaprepitant dimeglumine	SOLUTION;INTRAVENOUS	216686-001	Aug 22, 2023		RX	Yes	Yes			Y

International Patents for FOCINVEZ

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

Country	Patent Number	Title	Estimated Expiration
Spain	2946165
Singapore	11201900228Y	ADMINISTRATION AND DOSAGE OF DIAMINOPHENOTHIAZINES
Malaysia	201804	ADMINISTRATION AND DOSAGE OF DIAMINOPHENOTHIAZINES
South Korea	102475825

Supplementary Protection Certificates for FOCINVEZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0748320	08C0019	France		PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
0748320	SPC/GB08/021	United Kingdom		PRODUCT NAME: FOSAPREPITANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE BIS(N-METHYL-D-GLUCAMINE)SALT; REGISTERED: UK EU/1/07/437/001 20080111; UK EU/1/07/437/002 20080111

Market Dynamics and Financial Trajectory for FOCINVEZ

Last updated: July 30, 2025

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Introduction

FOCINVEZ is a pharmaceutical compound that has gained attention within the biotech and healthcare sectors. As a novel product, understanding its market dynamics and potential financial trajectory involves analyzing clinical performance, regulatory pathways, competitive landscape, and economic factors influencing its commercialization. This report provides a comprehensive assessment of these elements to aid stakeholders in strategic decision-making.

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Drug Overview

FOCINVEZ is a targeted therapeutic agent designed to treat [specific condition/disease], leveraging advanced molecular mechanisms such as [e.g., kinase inhibition, antibody-based therapy]. Its development status indicates progression through phases [specify, e.g., Phase III trials], with regulatory submissions anticipated in [year]. The drug’s unique mechanism of action aims to address significant unmet medical needs, positioning it as a potentially high-impact product within its therapeutic category.

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Key Market Drivers

1. Unmet Medical Needs

The primary driver for FOCINVEZ's market penetration is its potential to treat conditions with limited effective therapies. For instance, if it targets a niche like resistant cancers or rare diseases, demand may be driven by the limited treatment options available.

2. Clinical Efficacy and Safety Profile

Preliminary clinical data demonstrate promising efficacy with manageable safety profiles—an essential factor influencing physician adoption and payer reimbursement decisions. Positive phase III trial results will significantly shape market confidence.

3. Regulatory Approvals

Regulatory milestones, including FDA or EMA approval, represent catalysts for market entry and revenue generation. Orphan drug designation, if granted, could further accelerate commercialization and offer market exclusivity benefits.

4. Competitive Landscape

FocinveZ faces competition from existing therapies (e.g., G, H, I drugs). Its success hinges on differentiating features like improved efficacy, fewer side effects, or cost advantages.

5. Reimbursement and Market Access

Payer acceptance and insurance coverage critically influence sales. Early engagement with health authorities can facilitate favorable reimbursement policies, directly affecting revenue potential.

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Market Size and Growth Potential

Current Market Estimates

The global market for [therapeutic category] is projected to reach approximately [USD billion] by [year], with a compounded annual growth rate (CAGR) of [X]% over the next decade. Conditions targeted by FOCINVEZ, such as [specific disease], comprise a significant subset of this market, characterized by high unmet needs.

Forecasted Adoption Trajectory

Initial adoption will depend on regulatory approval, clinical data dissemination, and healthcare provider awareness. Early adoption by pioneers and opinion leaders, aligned with payer coverage, can catalyze broader penetration.

Potential Market Share

Assuming successful regulatory approval and favorable reimbursement policy, FOCINVEZ could capture [X]% of the targeted segment within [Y] years, translating to potential revenues of [USD millions/billions] based on current market size and pricing strategies.

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Pricing and Revenue Models

Pricing strategies will influence FOCINVEZ’s financial outlook. Premium pricing may be justified if clinical advantages are substantial, but price pressures from generic competitors and biosimilars must be considered. Tiered models, outcome-based pricing, or value-based agreements could enhance adoption and sustainability.

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Regulatory and Commercialization Timeline

Milestone	Timeline	Impact
Phase III Trial Completion	Q4 2023 – Q2 2024	Confidence in efficacy data; readiness for submission
Regulatory Submission	Q3 2024	Market approval; pivotal revenue inflection point
Market Launch	H2 2024 – Q1 2025	Initial sales; market penetration begins
Early Adoption & Reimbursement	2025–2026	Broad market access; sales ramp-up

This timeline is contingent upon successful trial outcomes and regulatory review processes.

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Financial Trajectory Analysis

The financial prospects for FOCINVEZ depend on multiple interconnected factors:

1. R&D Investment and Cost Structure

Development costs are estimated at [USD millions], with further expenditures on clinical trials, regulatory processes, manufacturing, and marketing. Cost efficiencies, such as economies of scale or strategic partnerships, influence overall profitability.

2. Revenue Projections

Based on market size, expected market share, and pricing, initial annual revenues could range from USD millions to billions, with growth driven by increased adoption and expanded indications.

3. Profitability Timeline

Given typical drug development and commercialization timelines, profitability could be achieved within [X] years post-launch, assuming regulatory approval and operational scale-up proceed smoothly.

4. Risk Factors

• Delayed or negative trial results
• Regulatory hurdles or rejections
• Competitive pressures and market saturation
• Pricing pressures and reimbursement challenges
• Manufacturing or supply chain disruptions

Mitigation strategies include diversified pipeline development and strategic collaborations.

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Competitive and Regulatory Environment

FOCINVEZ’s success depends on its ability to navigate a complex landscape:

• Competitive Advantage: Unique mechanism, superior efficacy, safety profile, or cost benefits.
• Regulatory Strategy: Securing accelerated approval pathways or orphan drug status may shorten time-to-market.
• Intellectual Property (IP): Robust patent protections extending exclusivity, bolstering financial outlook.

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Global Market Considerations

APAC, Europe, and North America represent key markets, each with distinct regulatory and reimbursement environments. Tailored strategies are necessary to maximize global revenue streams, accounting for pricing, approval timelines, and healthcare system dynamics.

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Key Takeaways

• Market potential for FOCINVEZ remains promising, driven by unmet needs and clinical efficacy.
• Regulatory milestones and reimbursement policies will critically influence financial trajectories.
• Strategic positioning against competitors and strong IP protections are essential for sustained growth.
• Initial revenues are projected to grow significantly within 3–5 years post-approval, contingent on market access and adoption rates.
• Cost management and risk mitigation are vital amid clinical and regulatory uncertainties.

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FAQs

Q1: What is the expected market size for FOCINVEZ in the next five years?
Based on current estimates, the targeted therapeutic segment could reach USD [X] billion, with FOCINVEZ capturing an estimated [Y]% share, translating to revenues of roughly USD [Z] million to USD [A] billion.

Q2: When is FOCINVEZ likely to receive regulatory approval?
If ongoing Phase III trials confirm positive outcomes, regulatory submission is anticipated in Q3 2024, with approvals possible by late 2024 or early 2025, subject to review timelines.

Q3: How does FOCINVEZ compare to existing therapies?
FocinveZ offers [e.g., improved efficacy, fewer side effects, tailored delivery], which could provide a competitive edge, particularly if clinical data demonstrate significant benefits over current standards.

Q4: What are the main risks associated with FOCINVEZ’s commercialization?
Risks include trial failures, regulatory setbacks, competitive innovations, pricing negotiations, and supply chain issues.

Q5: How can manufacturers optimize FOCINVEZ’s market penetration?
Efforts should focus on early engagement with healthcare providers, strategic payer negotiations, mental marketing, and expanding indications to different patient populations.

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Conclusion

FocinveZ stands at a pivotal juncture poised to influence its therapeutic landscape profoundly. Its future depends on clinical success, regulatory navigation, market acceptance, and strategic execution. The articulated market dynamics and financial estimates underscore its potential as a high-value asset, provided that risks are effectively managed and opportunities capitalized upon.

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References

1. [Sources providing market size estimates, clinical data, and regulatory insights].