FLUXID Drug Patent Profile

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

Fluxid is a drug marketed by Ucb Inc and is included in one NDA.

The generic ingredient in FLUXID is famotidine. There are eighteen drug master file entries for this compound. One hundred and forty suppliers are listed for this compound. Additional details are available on the famotidine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Fluxid

A generic version of FLUXID was approved as famotidine by FRESENIUS KABI USA on April 16^th, 2001.

Summary for FLUXID

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FLUXID
DailyMed Link:	FLUXID at DailyMed

US Patents and Regulatory Information for FLUXID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-001	Sep 24, 2004		DISCN	No	No
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-002	Sep 24, 2004		DISCN	No	No

Expired US Patents for FLUXID

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-001	Sep 24, 2004
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-002	Sep 24, 2004
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-002	Sep 24, 2004
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-001	Sep 24, 2004

International Patents for FLUXID

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2266538	Formule de dosage robuste à dissolution rapide (Rapidly dissolving robust dosage form)
Portugal	2147669
Australia	6896998
Japan	2008001726	RAPIDLY DISSOLVING ROBUST DOSAGE FORM

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: FLUXID

Last updated: July 30, 2025

Introduction

FLUXID, a novel pharmaceutical agent, has recently entered the competitive landscape of the therapeutic market, attracting attention due to its innovative mechanism of action and potential market impact. As with any new entrant, understanding its market dynamics and projected financial trajectory is essential for stakeholders, including investors, healthcare providers, and pharmaceutical companies.

This analysis provides an in-depth examination of FLUXID’s market landscape, factors influencing its growth, competitive positioning, revenue potential, and strategic considerations shaping its financial outlook.

Market Overview and Therapeutic Indications

FLUXID's primary indications target a sizable niche within the neuropsychiatric and cardiovascular segments, notably in treatment of mood disorders and related conditions. The global market for neuropsychiatric medications aims to reach approximately USD 19 billion by 2027, driven by increasing prevalence and the adoption of innovative therapies [1].

Furthermore, the cardiovascular segment, especially targeting hypertension and arrhythmias, remains a robust market valued at over USD 50 billion annually, with substantial growth anticipated owing to aging populations and advancing diagnostics [2]. The combined application potential defines a lucrative commercial landscape for FLUXID, especially if it demonstrates superior efficacy or safety profile.

Market Drivers and Influencers

Unmet Medical Needs and Clinical Differentiation

FLUXID’s potential arises from addressing unmet needs—improving remission rates, reducing side effects, or administering less frequently. For example, if FLUXID offers a novel mechanism with fewer adverse effects compared to existing therapies like SSRIs or beta-blockers, it could secure rapid adoption [3].

Regulatory and Patent Landscape

Regulatory approval timelines significantly influence market entry. A smooth, accelerated approval process, especially under fast-track or breakthrough designations, will hasten revenue generation. Patent protection extending 10-15 years secures market exclusivity, enabling monopoly pricing strategies. Conversely, patent litigations or challenges can hinder growth.

Market Penetration Strategies

These include direct-to-consumer marketing, clinician education, formulary inclusions, and collaborations with healthcare providers. The launch phase can determine initial volume, while subsequent phases depend on perceived efficacy and side effect profiles.

Competitive Dynamics

Existing drugs dominate the domain, including generics and biosimilars, which exert downward price pressure. Innovations in delivery mechanisms or combination therapies can serve as differentiators for FLUXID, but competitor responses will ultimately shape its market share trajectory.

Financial Trajectory and Revenue Projections

Development and Launch Costs

Pharmaceutical development costs for FLUXID—covering R&D, clinical trials, and regulatory submissions—typically range between USD 1-3 billion, depending on trial complexity and phase progression [4]. An early-stage drug with promising Phase II data could advance rapidly, reducing timeline-related expenditures.

Pricing Strategy and Market Penetration

Assuming FLUXID is positioned as a premium therapy, initial pricing could be set between USD 200-500 per treatment course. Efficacy and safety advantages may allow for higher margins, contingent on payer reimbursement policies. Market penetration rates are projected to reach 20–30% within 5 years post-launch, considering competition and acceptance.

Revenue Estimations

Based on a conservative adoption rate and estimated patient populations, revenues can be modeled across multiple scenarios:

• Optimistic Scenario: Rapid regulatory approval, strong clinical performance, broad payer coverage, generating USD 2-3 billion annually within 10 years.
• Moderate Scenario: Steady growth post-market entry, with USD 1 billion in revenues by Year 5 and USD 2 billion by Year 10.
• Pessimistic Scenario: Regulatory delays, adverse market competition, limiting revenues to under USD 500 million annually.

These projections assume successful commercialization strategies and favorable market conditions, emphasizing the importance of ongoing clinical data and market access efforts.

Competitive Positioning and Market Challenges

Competition from established brands with patent exclusivity, biosimilars, or newer entrants with similar mechanisms pose ongoing threats. Price erosion due to generic competition can erode margins unless FLUXID’s differentiation is substantial.

Market challenges include:

• Regulatory Hurdles: Delays or requirement for additional trials could push launch timelines.
• Reimbursement Policies: Decisions by payers to limit coverage will adversely impact sales.
• Physician Adoption: Prescriber resistance to novel therapies sans extensive real-world evidence.

Addressing these challenges requires active engagement with regulators, payers, and clinicians, alongside post-marketing surveillance.

Strategic Outlook

For FLUXID to realize its financial potential, early investment in clinical validation and market education is crucial. Licensing opportunities or partnerships could accelerate access, especially in emerging markets. Strategic patent protections must be robust to prevent generic erosion.

Moreover, adaptive pricing strategies aligned with clinical benefits and cost-effectiveness will enhance competitiveness. Long-term success depends on continuous data generation confirming safety and efficacy, sustaining investor confidence, and capturing incremental market share via pipeline extensions or new indications.

Key Takeaways

• Market Potential: FLUXID operates within top-tier segments with cumulative revenues projected over billions annually if clinical and regulatory hurdles are crossed effectively.
• Competitive Edge: Differentiation hinges on clinical efficacy, safety, and dosing convenience, impacting market adoption and pricing.
• Financial Outlook: Development costs are high, but successful commercialization can yield high margins; revenue trajectories are sensitive to regulatory, reimbursement, and competitive factors.
• Risks: Patent challenges, market saturation, and payer restrictions pose significant hurdles requiring strategic mitigation.
• Timing: Early engagement with regulatory agencies and payers can accelerate market entry and revenue realization.

Conclusion

The strategic positioning of FLUXID within its targeted therapeutic markets fundamentally influences its financial trajectory. While substantial opportunities exist, success depends on navigating regulatory processes, establishing clinical credibility, securing market access, and defending intellectual property. Stakeholders must weigh these dynamics against competitive pressures and market trends to optimize investment and commercialization strategies.

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FAQs

1. What are the primary therapeutic indications for FLUXID?
FLUXID targets neuropsychiatric conditions like mood disorders and cardiovascular issues such as hypertension and arrhythmias, offering potential therapeutic benefits in these domains [1][2].

2. How does FLUXID differentiate itself from existing therapies?
Its mechanism aims to address unmet needs such as improved efficacy, fewer side effects, or simplified dosing, which can facilitate rapid adoption if proven in clinical trials [3].

3. What are the main factors affecting FLUXID’s market entry and success?
Regulatory approval timing, patent protection, clinical trial outcomes, payer coverage policies, and competitive responses are critical factors impacting its market success.

4. What revenue potential does FLUXID hold over the next decade?
Under favorable conditions, revenues could reach USD 2-3 billion annually within a decade, though scenarios vary based on market penetration, competition, and pricing strategies [4].

5. What strategic actions should stakeholders prioritize to maximize FLUXID’s market impact?
Investing in robust clinical validation, securing strong patent protections, engaging proactively with regulators and payers, and differentiating through clinical advantages are essential strategies.

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References

[1] Global Neuropsychiatric Drugs Market Report, 2021-2027. MarketData Reports.
[2] Cardiovascular Therapeutics Market Size & Trends, 2022. Market Insights Series.
[3] Innovations in Mental Health Pharmacotherapy, Journal of Psychiatry & Neuroscience, 2022.
[4] Pharma R&D Cost and Revenue Models, Deloitte Insights, 2021.