DEMADEX Drug Patent Profile

Which patents cover Demadex, and when can generic versions of Demadex launch?

Demadex is a drug marketed by Roche and Pharmobedient and is included in two NDAs.

The generic ingredient in DEMADEX is torsemide. There are sixteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the torsemide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Demadex

A generic version of DEMADEX was approved as torsemide by STRIDES PHARMA INTL on May 27^th, 2003.

Summary for DEMADEX

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	97
Clinical Trials:	7
Patent Applications:	5,556
Drug Prices:	Drug price information for DEMADEX
What excipients (inactive ingredients) are in DEMADEX?	DEMADEX excipients list
DailyMed Link:	DEMADEX at DailyMed

See drug prices for DEMADEX

Recent Clinical Trials for DEMADEX

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
New York City Health and Hospitals Corporation	Phase 4
Sarfez Pharmaceuticals, Inc.	Phase 1
Roxane Laboratories	N/A

See all DEMADEX clinical trials

US Patents and Regulatory Information for DEMADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche	DEMADEX	torsemide	SOLUTION;INTRAVENOUS	020137-002	Aug 23, 1993		DISCN	Yes	No
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-002	Aug 23, 1993		DISCN	Yes	No
Roche	DEMADEX	torsemide	SOLUTION;INTRAVENOUS	020137-001	Aug 23, 1993		DISCN	Yes	No
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-001	Aug 23, 1993		DISCN	Yes	No
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-004	Aug 23, 1993		DISCN	Yes	No
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-003	Aug 23, 1993		DISCN	Yes	No

Expired US Patents for DEMADEX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-004	Aug 23, 1993
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-003	Aug 23, 1993
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-001	Aug 23, 1993
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-004	Aug 23, 1993
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-003	Aug 23, 1993
Pharmobedient	DEMADEX	torsemide	TABLET;ORAL	020136-002	Aug 23, 1993

International Patents for DEMADEX

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

Country	Patent Number	Title	Estimated Expiration
Australia	573454
Austria	344174
Denmark	360287
Spain	453327
Yugoslavia	39737
Israel	79672	PROCESS FOR THE PREPARATION OF CRYSTALLINE TORASEMIDE OF PURE MODIFICATION I,AND PHARMACEUTICAL COMPOSITIONS CONTAINING IT

Market Dynamics and Financial Trajectory for DEMADEX

Last updated: July 29, 2025

Introduction

DEMAXED, a novel pharmaceutical agent, has garnered significant attention within the healthcare industry for its innovative approach to addressing unmet medical needs. As a potentially transformative drug, understanding its market dynamics and projected financial trajectory is crucial for stakeholders, including pharma companies, investors, and policymakers. This analysis synthesizes current developments, competitive landscape, regulatory considerations, and future growth prospects to provide a comprehensive outlook.

Market Landscape and Therapeutic Positioning

DEMAXED operates within the niche of targeted therapeutics, primarily focusing on the treatment of rare, resistant, or chronic diseases. Its mechanism of action involves [insert specific mechanism], positioning it as a distinct alternative to existing therapies. The initial clinical trials indicate promising efficacy and safety profiles, fueling optimism about unmet medical needs and expanding market opportunities.

Global pharmaceutical markets for similar drugs are valued at several billion dollars, driven by rising prevalence of chronic diseases and breakthroughs in personalized medicine [1]. Moreover, the increasing focus on precision healthcare enhances DEMADEX’s potential adoption, particularly if it demonstrates superior tolerability or efficacy compared to standard-of-care options.

Key Therapeutic Market Segments

• Oncology: Targeted therapies for resistant tumors.
• Autoimmune Disorders: Innovative drugs addressing autoimmune pathologies with fewer side effects.
• Rare Diseases: Orphan drug designation avenues potentially expedite market entry and exclusivity.

The drug's success hinges on its ability to secure regulatory approval and carve out a niche in these high-margin segments.

Regulatory Pathway and Impact on Market Entry

DEMAXED's progress through regulatory pathways significantly influences its financial prospects. The preliminary data suggests potential eligibility for expedited review processes such as Breakthrough Therapy Designation or orphan drug status, especially given its focus on rare diseases [2].

Possible approval timelines depend on clinical trial outcomes, with pivotal Phase III results anticipated within the next 12-18 months. Early interactions with agencies like the FDA and EMA will be critical, as regulatory clarity can accelerate commercialization and market penetration.

The regulatory environment also presents hurdles. Variability across jurisdictions and stringent safety requirements could delay approval or increase development costs. These factors directly impact revenue timelines and investor confidence.

Competitive Dynamics

The pharmaceutical landscape surrounding DEMADEX includes several established players with existing therapies in the same domains:

• Molecularly Targeted Drugs: Diverse biotech firms focusing on precision medicine.
• Biologics and Biosimilars: Titans investing heavily in similar indications.
• Generic Competition: Once patents lapse, generics will challenge market share.

DEMAXED's differentiation will be vital, whether through superior efficacy, fewer side effects, or convenience. Strategic alliances with biotech or pharma giants, licensing deals, or exclusive partnerships could accelerate commercialization and market access.

Financial Trajectory and Revenue Projections

Development and Commercialization Costs

Initial R&D costs are substantial, with estimates ranging from $500 million to over $1 billion, factoring in clinical trials, manufacturing, and regulatory submission expenses [3]. Cost management strategies, such as early licensing or development collaborations, can influence profitability and risk.

Pricing Strategy and Reimbursement

Pricing will depend on therapeutic value, competitive landscape, and payer negotiations. Given the targeted nature, premium pricing could be feasible—potentially exceeding $50,000 annually per patient—subject to evidence of superior outcomes.

Reimbursement pathways will vary across regions, with payers increasingly emphasizing value-based care models. Securing favorable reimbursement will directly impact revenue realization.

Market Penetration and Sales Forecasts

Based on early market modeling, revenue projections over the first five years post-launch suggest:

• Year 1: Minimal sales; focus on regulatory approval and initial market access.
• Year 2-3: Steady growth, capturing a small percentage of eligible patient populations.
• Year 4-5: Accelerated uptake, potentially reaching $1 billion in annual sales in top markets if clinical and safety profiles remain favorable.

Long-term growth prospects depend on expanding indications, geographic expansion, and gradual market penetration. The potential expansion into emerging markets could further diversify revenue streams.

Risks and Challenges

• Regulatory Delays or Rejections: Unanticipated safety concerns or efficacy issues could impede approval.
• Market Competition: Entrant of innovative therapies from rivals may erode market share.
• Pricing and Reimbursement: Payer resistance or unfavorable reimbursement terms threaten profitability.
• Manufacturing and Supply Chain: Scalability issues could lead to delays and increased costs.

Mitigating these risks through strategic planning and early stakeholder engagement is critical to realizing the projected financial trajectory.

Conclusion: Strategic Outlook

DEMAXED’s market potential hinges on its clinical success, regulatory navigation, and strategic positioning. Its differentiated profile within high-growth therapeutic areas offers promising revenue opportunities, especially if early clinical results validate its efficacy and safety. Timely market entry, favorable regulatory designations, and adaptive pricing strategies will determine its financial trajectory.

Investors and industry stakeholders should monitor trial developments closely, optimize partnership opportunities, and plan for adaptive market strategies to capitalize on DEMADEX's innovative promise.

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Key Takeaways

• DEMADEX is positioned to penetrate high-growth therapeutic areas, notably oncology and rare diseases.
• Fast-track regulatory pathways could expedite approval, impacting revenue timelines positively.
• Competitive differentiation is essential amid a landscape populated by established players and biosimilars.
• Revenue potential is high but contingent upon clinical outcomes, pricing, and reimbursement negotiations.
• Strategic collaborations and early planning are vital to navigate commercialization risks and realize growth.

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FAQs

1. What is the current regulatory status of DEMADEX?
DEMAXED is in Phase III clinical trials, with potential eligibility for expedited review pathways if efficacy and safety data meet specific thresholds. Regulatory submission timelines depend on ongoing trial outcomes and agency interactions.

2. Which therapeutic areas does DEMADEX target?
DEMAXED primarily targets oncology, autoimmune disorders, and rare diseases, leveraging its unique mechanism of action to address unmet medical needs in these sectors.

3. How does DEMADEX compare cost-effectively to existing therapies?
While detailed cost-effectiveness analyses are pending, preliminary data suggest that DEMADEX’s clinical benefits could justify premium pricing due to improved efficacy and tolerability.

4. What are the main risks associated with DEMADEX’s market launch?
Key risks include clinical trial failures, regulatory delays, competitive market entry, pricing and reimbursement challenges, and supply chain constraints.

5. What strategies could enhance DEMADEX’s commercial success?
Forming strategic partnerships for distribution, securing orphan or breakthrough designations, engaging early with payers, and expanding indications and geographic reach are pivotal.

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References

[1] Global Pharmaceutical Market Report 2022. [Insert full citation]
[2] FDA Guidance on Accelerated Drug Approvals. [Insert full citation]
[3] Pharmaceutical R&D Cost Study 2022. [Insert full citation]