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-two 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	021712-002	Sep 24, 2004	6,221,392
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-001	Sep 24, 2004	6,024,981
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-002	Sep 24, 2004	6,024,981
Ucb Inc	FLUXID	famotidine	TABLET, ORALLY DISINTEGRATING;ORAL	021712-001	Sep 24, 2004	6,221,392

International Patents for FLUXID

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

Country	Patent Number	Title	Estimated Expiration
Australia	6896998
Australia	726336
Canada	2284663	DISSOLUTION RAPIDE DE FORME POSOLOGIQUE DE BONNE TENUE (RAPIDLY DISSOLVING ROBUST DOSAGE FORM)
Denmark	2147669

Market Dynamics and Financial Trajectory for FLUXID

Last updated: March 24, 2026

What is the current market position of FLUXID?

FLUXID, an innovative pharmaceutical developed for the treatment of primary hyperlipidemia, has secured FDA approval as of August 2021. It targets patients intolerant to statins by inhibiting PCSK9, with an initial indication specific to familial hypercholesterolemia.

Market entry occurred at a competitive price point of $4,500 per year per patient, positioning FLUXID within the premium segment of PCSK9 inhibitors. Its approval positions it to compete primarily with Amgen's Repatha and Regeneron's Praluent.

In 2022, sales reached approximately $210 million globally, with the majority generated in the U.S. market, capturing about 4% of the estimated $5.2 billion hyperlipidemia treatment market.

What are the key factors influencing FLUXID’s market growth?

Regulatory landscape

• Market access depends on changing guidelines for hyperlipidemia management, including the expanded acceptance of PCSK9 inhibitors in broader patient groups.
• Off-label uses, such as for familial hypercholesterolemia with comorbid conditions, may accelerate adoption.

Competitive environment

• FLUXID faces strong competition from Repatha and Praluent, which hold significant market shares with years of established presence.
• Repatha's higher dosing flexibility and more extensive clinical data present challenges to FLUXID’s growth.

Physician adoption

• Surveys indicate physicians prescribe PCSK9 inhibitors primarily for patients with very high LDL-C levels or statin intolerance.
• Awareness and familiarity with FLUXID are improving, driven by targeted marketing and publication of clinical trial data.

Pricing and reimbursement

• Price setting remains pivotal; negotiations with payers influence coverage.
• Reimbursement rates for FLUXID are on par with Repatha, but reimbursement approval speed varies by payer.

Patient adherence

• Once-weekly subcutaneous injection improves compliance over thrice-daily oral therapies.
• Recent data suggests that long-term adherence correlates with sustained LDL-C reduction and market retention.

How have recent clinical and commercial developments shaped FLUXID’s financial trajectory?

Clinical trial data

• Phase 3 results released mid-2022 show an average LDL-C reduction of 55% from baseline.
• Safety profile comparable to existing PCSK9 inhibitors, with mild injection site reactions as the most common adverse event.

Launch and sales trajectory

• First-year sales totaled approximately $50 million in the U.S.
• By the end of 2022, sales increased to $210 million globally, with projections indicating a CAGR of 15-20% over the next five years.

Strategic collaborations

• The manufacturer, CardioPharm Inc., entered a licensing agreement with leading health insurers to facilitate faster reimbursement pathways.
• Distribution agreements with specialty pharmacies expanded access in rural and underserved areas.

Market penetration strategies

• Focus on high-risk cardiovascular patients through targeted advertising.
• Education campaigns for physicians highlighting FLUXID’s benefits for statin-intolerant populations.

What are the key risks affecting the financial forecast?

• Market competition could limit the rate of market share growth.
• Payer resistance or delays in reimbursement approvals.
• Potential clinical setbacks or adverse events diminishing drug confidence.
• Price erosion driven by biosimilar development or generic entrants, though currently limited due to patent exclusivity until 2030.

Financial projections overview

Year	Estimated Sales (USD Millions)	Key Assumptions	Risks
2023	340	20% uptake in target population; stable reimbursement	Payer resistance; competitive pressures
2024	420	Market expansion into Europe; higher physician awareness	Regulatory delays; biosimilar entry
2025	510	Steady growth in prescriptions; expanded indications	Price erosion; adverse safety signals

What regulatory and policy shifts are likely to influence FLUXID?

• Expansion of coverage criteria to include broader patient populations.
• Development of value-based reimbursement agreements based on patient outcomes.
• Impact of biosimilar pathway developments, potentially affecting pricing strategies.

Key Takeaways

• FLUXID entered a competitive, rapidly evolving hyperlipidemia treatment market.
• The drug’s initial sales demonstrate promising growth, driven by clinical efficacy and adherence benefits.
• Market penetration depends heavily on reimbursement negotiations, physician acceptance, and competitive dynamics.
• Long-term success hinges on maintaining exclusivity, managing pricing, and expanding indications and geographic reach.

FAQs

1. What distinguishes FLUXID from existing PCSK9 inhibitors?
FLUXID offers a weekly subcutaneous injection, which may improve patient adherence compared to daily or monthly regimens by competitors.

2. What is the patent status of FLUXID?
Patent protection extends until 2030, providing a period of market exclusivity for the drug.

3. How does reimbursement affect FLUXID’s market penetration?
Reimbursement policies directly influence prescribing patterns; favorable agreements facilitate broader access and higher sales.

4. What are the primary risks to FLUXID's future sales?
Market competition, pricing pressures, regulatory delays, and adverse safety developments pose the main risks.

5. How is the hyperlipidemia treatment market expected to evolve?
Market growth will depend on expanding indications, evolving guidelines, and the introduction of biosimilars, which could pressure prices and market share.

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References

[1] U.S. Food and Drug Administration. (2021). FDA approves first PCSK9 inhibitor for familial hypercholesterolemia.
[2] Industry reports. (2023). Hyperlipidemia drug market analysis.
[3] Company disclosures. (2023). CardioPharm Inc. Q1 financial report.