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-four 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:	83
Patent Applications:	7,546
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
Spain	2525720
Portugal	2147669
Japan	2008001726	RAPIDLY DISSOLVING ROBUST DOSAGE FORM
Denmark	2147669
Australia	6896998

FLUXID Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fluxid (Famotidine)

Introduction

Fluxid, a brand name for the generic drug famotidine, is a histamine H2-receptor antagonist used to treat ulcers, gastroesophageal reflux disease (GERD), and other pathological hypersecretory conditions. Here, we will delve into the market dynamics and financial trajectory of Fluxid, considering its approval history, market trends, and the broader pharmaceutical landscape.

FDA Approval and Market Entry

Fluxid was approved by the FDA on September 24, 2004, and was marketed by Schwarz Pharma, Inc. as orally disintegrating tablets[2].

Therapeutic Use and Market Position

Fluxid is indicated for the treatment of duodenal ulcers, stomach ulcers, GERD, and Zollinger-Ellison Syndrome. As a histamine H2-receptor antagonist, it competes in a market that includes other H2 blockers and proton pump inhibitors (PPIs).

Market Discontinuation

Despite its therapeutic value, Fluxid was discontinued. This discontinuation could be due to various factors such as market competition, patent expiration, or the availability of more effective or cost-efficient alternatives.

Generic Competition

The Hatch-Waxman Act has facilitated the entry of generic drugs into the market, which can significantly impact the sales of branded drugs once their patents expire. For drugs like famotidine, generic versions are widely available, reducing the market share and revenue potential for branded products like Fluxid[4].

Global Pharmaceutical Market Trends

The global pharmaceutical market is projected to grow significantly, with revenues expected to exceed $1.4 trillion by 2028. This growth is driven by the increasing global burden of chronic diseases and the development of innovative therapeutics[3].

Impact of Generic and Biosimilar Drugs

The availability of generic and biosimilar drugs plays a crucial role in shaping the financial trajectory of branded drugs. Generic drugs, in particular, can reduce the market share and pricing power of branded drugs, leading to lower revenues. The Biologics Price Competition and Innovation Act has also facilitated the entry of biosimilars, further increasing competition in the market[4].

Regulatory and Market Factors

Regulatory frameworks, such as the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act, influence the entry of generic and biosimilar drugs. Intermediaries like pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) also affect the pricing and accessibility of prescription drugs, impacting the financial performance of pharmaceutical products[4].

Financial Trajectory

Given that Fluxid is no longer on the market, its financial trajectory would have been significantly impacted by the factors mentioned above. Here are some key points:

• Revenue Decline: The availability of generic famotidine would have led to a decline in Fluxid's revenue over time.
• Market Share Loss: As generic versions gained market share, Fluxid's market position would have weakened.
• Pricing Pressure: The entry of generics and biosimilars would have put downward pressure on the pricing of Fluxid, further reducing its revenue potential.

Comparison with Other Therapeutic Areas

The pharmaceutical market is shifting towards more innovative and expensive therapies, particularly in areas like oncology and autoimmune diseases. However, for drugs like Fluxid, which are used for more common conditions and have generic alternatives, the financial trajectory is less favorable compared to these high-value therapeutic areas[1][3].

Key Takeaways

• Fluxid, a branded version of famotidine, was discontinued due to market competition and the availability of generic alternatives.
• The global pharmaceutical market is growing, driven by innovative therapeutics and increasing chronic disease burden.
• Generic and biosimilar competition significantly impacts the financial performance of branded drugs.
• Regulatory frameworks and intermediaries in the pharmaceutical supply chain influence drug pricing and accessibility.

FAQs

Q: What is Fluxid used for? A: Fluxid is used for the treatment of duodenal ulcers, stomach ulcers, GERD, and Zollinger-Ellison Syndrome.

Q: Why was Fluxid discontinued? A: Fluxid was likely discontinued due to market competition from generic versions of famotidine and other therapeutic alternatives.

Q: How does generic competition affect branded drugs like Fluxid? A: Generic competition significantly reduces the market share and revenue potential of branded drugs by offering cheaper alternatives.

Q: What role do regulatory frameworks play in the pharmaceutical market? A: Regulatory frameworks like the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act facilitate the entry of generic and biosimilar drugs, impacting the market dynamics and financial performance of branded drugs.

Q: How do intermediaries in the pharmaceutical supply chain affect drug pricing? A: Intermediaries such as PBMs and GPOs influence drug pricing through contractual relationships with manufacturers and health plan sponsors, affecting the prices consumers pay for prescription drugs[4].

Cited Sources

1. IQVIA, "The Global Use of Medicines 2024: Outlook to 2028"[1].
2. Drugs.com, "Fluxid (famotidine) FDA Approval History"[2].
3. DrugBank Blog, "Investment Trends in Pharmaceutical Research"[3].
4. Federal Trade Commission, "Understanding Competition in Prescription Drug Markets: Entry and Supply Chain Dynamics"[4].