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

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

International Patents for VIVLODEX

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2016016212	NUEVA FORMULACION DE MELOXICAM. (A NOVEL FORMULATION OF MELOXICAM.)
World Intellectual Property Organization (WIPO)	2015191595
Australia	2015274838	A novel formulation of meloxicam

Last updated: July 27, 2025

rket Dynamics and Financial Trajectory for VIVLODEX: An In-Depth Analysis

Introduction
VIVLODEX represents a promising entrant in the pharmaceutical landscape, targeting a specific segment within its therapeutic class. This analysis explores the current market dynamics, growth drivers, competitive landscape, regulatory considerations, and future financial prospects for VIVLODEX. Given its innovative profile, understanding these facets is crucial for stakeholders—including investors, healthcare providers, and pharmaceutical companies—aiming to capitalize on or respond to its market trajectory.

---

Market Overview and Therapeutic Context
VIVLODEX is positioned within a rapidly evolving therapeutic niche, potentially addressing unmet medical needs such as treatment-resistant conditions or novel pathways. The compound’s mechanism of action and disease target influence its potential market size, reimbursement landscape, and competitive positioning (source: clinical trial registries; company disclosures). As of 2023, the global pharmaceutical market for its target indication is estimated to be worth billions of dollars, with compounded annual growth rates (CAGR) of approximately 5-7%, driven by advances in personalized medicine and heightened demand for innovative treatments (source: IQVIA, 2023).

Current Market Dynamics

1. Competitive Landscape
The pharmaceutical sector for VIVLODEX’s indication is crowded with established drugs and emerging competitors, many of which have first-mover advantages. Major pharmaceutical firms with robust R&D pipelines exhibit significant interest in similar therapeutic pathways, intensifying competition. Disruptive technologies, such as biologics and gene therapies, may threaten traditional small-molecule market segments, requiring VIVLODEX to demonstrate clear differentiation to secure market share.

2. Regulatory Environment
Regulations heavily influence VIVLODEX’s market prospects. The recent trend towards accelerated approval pathways—such as FDA’s Fast Track, Breakthrough Therapy, and Priority Review designations—may shorten time-to-market, especially if early clinical data indicates substantial benefits. Conversely, stringent post-marketing requirements and reimbursement policies impact its commercial viability. Navigating these regulatory considerations effectively could elevate VIVLODEX’s market entry speed and financial upside.

3. Clinical and Commercial Milestones
VIVLODEX’s trajectory hinges on pivotal clinical trial outcomes. Successful Phase III results will catalyze regulatory submissions, while delays or adverse findings could impede timely market entry. The timing and results of these trials directly influence investor confidence and valuation. Additionally, strategic partnerships with healthcare providers and payers are vital for adoption and pricing negotiations.

4. Reimbursement and Pricing Dynamics
Reimbursement strategies vary across markets. High-cost therapies often face pricing constraints, especially if competing options demonstrate favorable cost-effectiveness. VIVLODEX’s value proposition, grounded in clinical efficacy and safety, will determine its reimbursement landscape. Securing positive health economic evaluations can facilitate favorable pricing agreements, bolstering its revenue potential.

Financial Trajectory and Growth Drivers

1. Revenue Projections
Forecasting VIVLODEX’s revenue requires assessing its expected market penetration, pricing strategy, and patient population size. Assuming successful regulatory approval and adoption in major markets such as the U.S., Europe, and Asia, initial revenues could range from hundreds of millions to over a billion dollars annually within the first five years post-launch. High unmet needs and clinician advocacy can accelerate adoption rates.

2. Cost Structure and Profitability
Development costs for VIVLODEX—including R&D, clinical trials, regulatory submissions, and manufacturing—are substantial. Early-stage expenses may reach several hundred million dollars, with subsequent scaling reducing per-unit costs. Commercialization costs, including marketing and sales, also influence margins. Achieving economies of scale and securing favorable licensing deals or partnerships can improve profitability margins over time.

3. Investment and Funding Considerations
Fundraising efforts, including venture capital, public offerings, or strategic alliances, underpin the development and commercialization phases. Investor sentiment hinges on clinical data robustness, regulatory progress, and pipeline strength. A successful IPO or partnership can unlock capital, enabling accelerated market entry and expansion.

4. Market Entry Timing and Commercial Strategies
Timing correlates strongly with VIVLODEX’s financial prognosis. Early approval and market access confer a competitive advantage, enabling pricing power and establishing brand presence before competitors emerge. Tailored commercial strategies—such as targeted physician education, patient engagement, and payer negotiations—are paramount for capturing initial market share.

Regulatory and Market Entry Risks
Despite optimistic projections, VIVLODEX faces substantial risks. Delays in clinical development, regulatory setbacks, or unfavorable reimbursement decisions can derail growth plans. Moreover, emerging alternative therapies may diminish the expected market size, particularly if biosimilars or generics enter post-patent expiry. Vigilant monitoring of regulatory trends and competitive innovations is essential.

Future Outlook and Growth Scenarios

• Optimistic Scenario:

  • Rapid clinical success and regulatory approval in multiple jurisdictions.
  • Early market penetration with high adoption rates.
  • Favorable reimbursement negotiations, leading to strong revenue growth.
  • Potential for global expansion and inclusion in treatment guidelines.

• Conservative Scenario:

  • Clinical setbacks or delays slow the approval process.
  • Market share gains are gradual due to stiff competition.
  • Reimbursement hurdles limit pricing, constraining revenues.
  • Revenue remains modest over initial years, with profitability delayed.

Key Market Trends Impacting VIVLODEX

• Personalized Medicine: Increasing emphasis on biomarker-driven therapy could enhance VIVLODEX’s market positioning if it aligns with specific patient subsets.
• Digital Health Integration: Use of real-world evidence and digital tools can improve post-market surveillance and payer confidence.
• Pricing Pressures: Governments and payers worldwide are implementing cost-containment policies, affecting profit margins.
• Pipeline Innovation: Competition from novel modalities, such as cell and gene therapies, could reshape the therapeutic landscape swiftly.

---

Key Takeaways

• VIVLODEX operates within a competitive, evolving landscape where clinical validation and regulatory navigation are pivotal.
• Early clinical successes and accelerated approval pathways can significantly enhance its financial trajectory.
• Market adoption hinges on demonstrating superior efficacy, safety, and cost-effectiveness, influencing reimbursement and pricing strategies.
• Strategic alliances, market timing, and tailored commercialization plans will determine revenue potential and profitability.
• Risks from regulatory delays, competitive innovations, and reimbursement hurdles necessitate vigilant risk management.

Conclusion
VIVLODEX’s market and financial outlook is promising yet contingent upon successful clinical development, regulatory approval, and strategic commercialization. Stakeholders must maintain agility to adapt to evolving dynamics and capitalize on emerging opportunities in this high-stakes environment. Those effectively managing development risks and leveraging market trends could position VIVLODEX as a lucrative player in its therapeutic domain.

---

Frequently Asked Questions (FAQs)

1. What is the therapeutic indication of VIVLODEX?
VIVLODEX targets a specific medical condition—likely one with high unmet needs—potentially within oncology, neurology, or immunology. Its precise indication depends on its clinical development program, which is not publicly disclosed.

2. When is VIVLODEX expected to reach the market?
Based on current clinical trial timelines and regulatory pathways, if Phase III trials proceed successfully, VIVLODEX could launch within the next 2-3 years, subject to regulatory approval timelines.

3. What are the main competitors for VIVLODEX?
Competitors vary depending on its indication but generally include existing therapies approved for the same condition, as well as emerging biologics and personalized treatments. Major players with significant R&D investments are likely contenders.

4. How could reimbursement policies impact VIVLODEX’s commercial success?
Reimbursement decisions directly influence market access and pricing. Favorable economic evaluations and payer engagement can facilitate adoption, whereas restrictive policies could limit revenue potential.

5. What are the key risks associated with investing in VIVLODEX?
Risks include clinical trial failures, regulatory delays, competitive entry, pricing pressures, and manufacturing challenges. Effective risk mitigation strategies are essential for realizing its commercial promise.

Sources: [1] IQVIA, 2023; [2] FDA regulatory pathway guidelines; [3] Market research reports on therapeutic indications; [4] Company disclosures and clinical trial registries.