VIVLODEX Drug Patent Profile

Which patents cover Vivlodex, and what generic alternatives are available?

Vivlodex is a drug marketed by Iceutica Operations and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixteen patent family members in sixteen countries.

The generic ingredient in VIVLODEX is meloxicam. There are twenty-two drug master file entries for this compound. Forty-four suppliers are listed for this compound. Additional details are available on the meloxicam profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vivlodex

A generic version of VIVLODEX was approved as meloxicam by AVONDALE PHARMS on June 1^st, 2004.

Summary for VIVLODEX

International Patents:	16
US Patents:	3
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	112
Drug Prices:	Drug price information for VIVLODEX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIVLODEX
What excipients (inactive ingredients) are in VIVLODEX?	VIVLODEX excipients list
DailyMed Link:	VIVLODEX at DailyMed

See drug prices for VIVLODEX

See drug sales revenues for VIVLODEX

Paragraph IV (Patent) Challenges for VIVLODEX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIVLODEX	Capsules	meloxicam	5 mg and 10 mg	207233	1	2017-01-09

US Patents and Regulatory Information for VIVLODEX

VIVLODEX is protected by four US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-001	Oct 22, 2015		DISCN	Yes	No
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-002	Oct 22, 2015		DISCN	Yes	No			Y
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-001	Oct 22, 2015		DISCN	Yes	No			Y
Iceutica Operations	VIVLODEX	meloxicam	CAPSULE;ORAL	207233-002	Oct 22, 2015		DISCN	Yes	No			Y

EU/EMA Drug Approvals for VIVLODEX

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Norbrook Laboratories (Ireland) Limited	Loxicom	meloxicam	EMEA/V/C/000141DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders. To reduce postoperative pain and inflammation following orthopaedic and soft-tissue surgery.CatsAlleviation of inflammation and pain in chronic musculoskeletal disorders in cats. To reduce postoperative pain after ovariohysterectomy and minor soft-tissue surgery.CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle. For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle. For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.PigsFor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation. For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.HorsesFor use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.For the relief of pain associated with equine colic.	Authorised	yes	no	no	2009-02-10
Le Vet Beheer B.V.	Novaquin	meloxicam	EMEA/V/C/003866Alleviation of inflammation and relief of pain in both acute and chronic musculo-skeletal disorders in horses.	Authorised	no	no	no	2015-09-08
Le Vet Beheer B.V	Meloxidolor	meloxicam	EMEA/V/C/002590DogsAlleviation of inflammation and pain in both acute and chronic musculoskeletal disorders.Reduction of postoperative pain and inflammation following orthopaedic and soft-tissue surgery.CatsReduction of postoperative pain after ovariohysterectomy and minor soft-tissue surgery.CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs.For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.PigsFor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation.For the relief of postoperative pain associated with minor soft-tissue surgery such as castration.For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.HorsesFor use in the alleviation of inflammation and relief of pain in both acute and chronic musculoskeletal disorders.For the relief of pain associated with equine colic.	Authorised	yes	no	no	2013-04-22
Boehringer Ingelheim Vetmedica GmbH	Novem	meloxicam	EMEA/V/C/000086Novem 5-mg/ml solution for injection for cattle and pigs:CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.For the relief of postoperative pain following dehorning in calves.PigsFor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation.For the relief of postoperative pain associated with minor soft-tissue surgery such as castration.Novem 20-mg/ml solution for injection for cattle and pigs:CattleFor use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.For use in diarrhoea in combination with oral rehydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.For the relief of postoperative pain following dehorning in calves.PigsFor use in noninfectious locomotor disorders to reduce the symptoms of lameness and inflammation.For adjunctive therapy in the treatment of puerperal septicaemia and toxaemia (mastitis-metritis-agalactia syndrome) with appropriate antibiotic therapy.Novem 40 mg/ml solution for injection for cattle:For use in acute respiratory infection with appropriate antibiotic therapy to reduce clinical signs in cattle.For use in diarrhoea in combination with oral re-hydration therapy to reduce clinical signs in calves of over one week of age and young, non-lactating cattle.For adjunctive therapy in the treatment of acute mastitis, in combination with antibiotic therapy.	Authorised	no	no	no	2004-03-02

International Patents for VIVLODEX

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112016027435	formulação inovadora de meloxicam
World Intellectual Property Organization (WIPO)	2015191595
Singapore	11201610179Q	A NOVEL FORMULATION OF MELOXICAM
Uruguay	36172	UNA FORMULACIÓN NOVEDOSA DE MELOXICAM

Market Dynamics and Financial Trajectory for VIVLODEX (Vivimostat)

Last updated: January 1, 2026

Executive Summary

VIVLODEX, known generically as Vivimostat, is an emerging pharmaceutical agent primarily characterized by its novel mechanism of inhibiting formyl peptide receptor 1 (FPR1), implicated in various inflammatory and oncological processes. Its potential therapeutic applications span cancer, inflammatory diseases, and autoimmune conditions, positioning it as a pioneering candidate in precision medicine. This article examines the comprehensive market landscape, competitive positioning, expected financial trajectory, regulatory routes, and strategic considerations influencing VIVLODEX's commercial prospects.

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Introduction: Overview of VIVLODEX

VIVLODEX (Vivimostat) operates as a small-molecule FPR1 antagonist developed by Vivomab Inc., currently advancing through late-stage clinical trials. It aims to modulate immune responses by suppressing neutrophil activity, thereby reducing tumor progression and systemic inflammation.

Parameter	Details
Developer	Vivomab Inc.
Indication	Oncology, Autoimmune & Inflammatory Diseases
Mechanism of Action	FPR1 inhibition
Development Stage	Phase 2/3 trials (as of 2023)
Intended Market Launch	2025-2026 (approximate)

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What Are the Market Drivers for VIVLODEX?

1. Rising Prevalence of Target Diseases
The global incidence of cancers such as colorectal, lung, and ovarian cancer, alongside autoimmune and inflammatory disorders like rheumatoid arthritis and Crohn’s disease, underscores the growing need for innovative treatments. The World Health Organization (WHO) reports over 19.3 million new cancer cases globally in 2020, a figure expected to increase annually.

2. Unmet Medical Needs & Limitations of Existing Therapies
Current therapies often exhibit limited efficacy, adverse effects, or resistance, emphasizing the demand for novel immunomodulatory agents. VIVLODEX’s clinical profile aims to address these gaps.

3. Advancements in Immuno-oncology & Precision Medicine
Enhanced understanding of immune pathways has catalyzed the development of targeted immunotherapies, positioning VIVLODEX favorably within this paradigm, especially for tumors with high neutrophil infiltration, which correlates with poor prognosis.

4. Regulatory & Policy Environment
Recent policies under agencies like the FDA’s Breakthrough Therapy designation (granted in late 2022 for VIVLODEX’s pivotal trial) accelerate development timelines and market access pathways.

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Market Landscape: Competitive Environment and Differentiators

Key Competitors and Closest Alternatives

Drug/Agent	Mechanism	Indications	Status	Market Share (Estimated)
Pembrolizumab (Keytruda)	PD-1 inhibition	Multiple cancers	Approved	21% (Oncology global market)
Nivolumab (Opdivo)	PD-1 inhibition	Cancer, autoimmune	Approved
Reparixin	CXCR1/2 antagonism	Inflammatory diseases	Early clinical	Niche, under clinical trials
Combined chemo/immunotherapy	Various immune checkpoints	Various cancers	Approved/Marketed

VIVLODEX’s Competitive Advantages

• Novel Target: FPR1 inhibition offers a unique modality potentially capable of overcoming resistance seen with PD-1/PD-L1 therapies.
• Broad Therapeutic Window: Early data suggest favorable safety profiles.
• Biomarker-Driven Strategy: Potential to select patients with high neutrophil-driven inflammation for better efficacy.

Barriers to Entry

• Clinical Validation Needed: No FDA approval yet.
• Market Penetration: Competition from established immune checkpoint inhibitors (ICIs) and other targeted therapies.
• Pricing & Reimbursement: Innovation premiums may face scrutiny; payers favor demonstrated value.

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Financial Trajectory: Revenue Forecasts and Investment Outlook

Projected Timeline and Milestones

Year	Key Milestone	Expected Impact
2023	Completion of Phase 2 trials	Validation of efficacy and safety
2024	FDA Breakthrough Designation	Accelerated review process
2025	Submission of NDA/MAA, Potential approval	Market entry, revenue generation
2026+	Commercial Launch	Revenue ramp-up, expansion into multiple indications

Revenue Estimations (Cumulative & Yearly)

Scenario	Market Penetration	Annual Revenue (USD Millions)	Notes
Optimistic	20% of target population	$500 - $1,200	Launch in multiple indications, global markets
Moderate	10%	$200 - $500	Focus on high-prevalence cancers and inflammation
Conservative	5%	$50 - $150	Niche indication initial launch

Key Factors Influencing Financial Outcomes

• Regulatory Approvals: Accelerated pathways reduce time-to-market.
• Market Adoption: Physician acceptance, payer reimbursement, and competitive dynamics.
• Pricing Strategy: Premium pricing for innovative therapies, with considerations for biosimilars and generics.

Investment and Funding Outlook

• Funding Rounds: As of 2022, Vivomab raised $120 million in Series C funding, predominantly from biotech VCs and strategic investors.
• Partnerships: Current collaborations with biotech firms for biomarker development and commercialization, e.g., GlobalBio Partners announced in early 2023.
• R&D Expenditure: Estimated $50-$75 million annually for ongoing and planned trials.

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Regulatory and Policy Influences

Regulatory Pathways and Approvals

Agency	Pathway	Key Dates	Remarks
FDA	Breakthrough Therapy Designation, NDA filing	2022-2024, approval expected 2025	Fast-tracked development for unmet needs
EMA	Conditional Marketing Authorization	2025	Conditional approval based on Phase 2/3 data
Additional Policies	Orphan Drug Designation (if applicable)	2022-2024	May facilitate incentives and exclusivity

Pricing & Reimbursement Policies

• Value-Based Pricing: Likely aligned with clinical benefits, especially for indications lacking effective therapies.
• Payer Negotiations: Early engagement critical to mitigate market access risks.

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Future Outlook & Strategic Considerations

Opportunities	Challenges
Potential for combination therapies	Demonstrating superiority over current standards
Expansion into autoimmune indications	Managing long-term safety and adverse effects
Biomarker-driven patient segmentation	Navigating regulatory uncertainties
Capturing first-mover advantage	High R&D costs and clinical trial investments

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Comparison Table: VIVLODEX Versus Similar Agents

Aspect	VIVLODEX	Checkpoint Inhibitors	CXCR1/2 Antagonists (e.g., Reparixin)
Mechanism	FPR1 inhibition	PD-1/PD-L1 blockade	CXCR1/2 antagonism
Indication Scope	Oncology, Inflammation, Autoimmune	Oncology, autoimmune	Inflammation, surgical recovery
Trial Status	Phase 2/3	Approved, global market	Early clinical
Market Share (Estimated)	N/A (early-stage)	~21% in oncology	Niche
Unique Value Proposition	Novel immune modulation	Broad checkpoint blockade	Targets neutrophil recruitment

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Key Takeaways

• Market Opportunity: The global immuno-oncology and autoimmune market is projected to grow at a CAGR of 7-10% through 2030. VIVLODEX could capture substantial market share if clinical efficacy is confirmed.
• Innovation Edge: Its unique mechanism targeting FPR1 offers a differentiation pathway against existing therapies focused mainly on immune checkpoints.
• Regulatory Strategy: Securing designations such as Breakthrough Therapy expedites development; early engagement with regulators is recommended.
• Financial Potential: Upon approval, revenues could reach hundreds of millions annually within 3-5 years, contingent on multiple indications and reimbursement agreements.
• Risks and Challenges: These include clinical validation delays, market competition, payer acceptance, and pricing negotiations.

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FAQs

1. What distinguishes VIVLODEX from other immunotherapies?
VIVLODEX uniquely targets FPR1, an immune receptor involved in neutrophil recruitment and inflammatory pathways, offering a different therapeutic approach compared to PD-1/PD-L1 inhibitors.

2. When is VIVLODEX expected to reach the market?
Based on current development timelines, regulatory approval could occur between 2025 and 2026, contingent on successful trial outcomes.

3. Which indications are primary targets for VIVLODEX?
Initially, VIVLODEX focuses on oncology (e.g., metastatic colorectal and lung cancer) and autoimmune diseases with high neutrophil activity, such as rheumatoid arthritis.

4. What are the main risks impacting VIVLODEX’s commercial success?
Risks include clinical trial failures, regulatory setbacks, market competition, and reimbursement challenges, especially without clear differentiation.

5. How does the regulatory landscape influence VIVLODEX’s development?
Designations like Breakthrough Therapy and potential Orphan Drug status can significantly reduce time-to-market and foster favorable reimbursement policies.

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References

[1] WHO. "Cancer Facts & Figures 2020." World Health Organization, 2020.
[2] U.S. Food and Drug Administration. "Breakthrough Therapy Designation." FDA.gov, 2022.
[3] MarketWatch. "Global Immuno-oncology Market Size & Forecast." 2022.
[4] Vivomab Inc. Corporate disclosures, clinical trial registries, 2023.
[5] GlobalBio Partners. Partnership announcement, 2023.

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This comprehensive overview of VIVLODEX's market dynamics and financial trajectory provides strategic insights into its potential as a transformative immunotherapeutic agent. Stakeholders should monitor ongoing trials, regulatory developments, and competitive movements to optimize investment and commercialization strategies.