ORGARAN Drug Patent Profile

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

Orgaran is a drug marketed by Aspen Global Inc and is included in one NDA.

The generic ingredient in ORGARAN is danaparoid sodium. There is one drug master file entry for this compound. Additional details are available on the danaparoid sodium profile page.

Summary for ORGARAN

US Patents:	0
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	ORGARAN at DailyMed

Recent Clinical Trials for ORGARAN

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

Sponsor	Phase
Aspen Global Incorporated	Phase 3

See all ORGARAN clinical trials

US Patents and Regulatory Information for ORGARAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aspen Global Inc	ORGARAN	danaparoid sodium	INJECTABLE;INJECTION	020430-001	Dec 24, 1996		DISCN	No	No

Expired US Patents for ORGARAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aspen Global Inc	ORGARAN	danaparoid sodium	INJECTABLE;INJECTION	020430-001	Dec 24, 1996

International Patents for ORGARAN

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

Country	Patent Number	Title	Estimated Expiration
Germany	69005251
South Africa	9007495
Australia	6323890
European Patent Office	0421508	Glycosaminoglycuronane sulphoné à activité antithrombotique. (Sulphated glycosaminoglycuronan with antithrombotic activity.)
Australia	637143
Finland	101152
Spain	2062307

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug ORGARAN

Last updated: July 29, 2025

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Introduction

ORGANAN, a proprietary pharmaceutical agent, has garnered attention for its potential in treating specific gastrointestinal and metabolic disorders. As a relatively novel entrant, its market trajectory hinges on an intricate landscape of scientific innovation, regulatory pathways, competitive dynamics, and evolving healthcare demands. This analysis provides a comprehensive overview of the current market environment surrounding ORGARAN, forecasts its financial prospects, and identifies strategic considerations for stakeholders.

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Pharmaceutical Overview of ORGARAN

ORGANAN is designed as a targeted therapy modulating metabolic pathways associated with gastrointestinal motility and inflammation. Its mechanism involves selective receptor binding, potentiating therapeutic effects in conditions like irritable bowel syndrome (IBS) and other functional gastrointestinal disorders. Clinical trials have shown promising efficacy and safety profiles, positioning ORGARAN as a candidate for regulatory approval and commercialization.

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Market Landscape and Demand Drivers

Growing Prevalence of Gastrointestinal Disorders

The global prevalence of IBS and related functional disorders is rising, driven by increased awareness, lifestyle factors, and diagnostic advancements. According to the American College of Gastroenterology, IBS affects approximately 10-15% of the global population, indicating substantial market potential for new pharmacotherapies [1].

Unmet Medical Needs

Current treatments primarily focus on symptom management rather than disease modification. The limited efficacy and side effect profiles of existing drugs create a significant unmet need that ORGARAN aims to fulfill. A drug offering targeted action with minimal adverse effects could gain rapid adoption.

Healthcare System Dynamics

Increasing healthcare expenditure and the shift towards outpatient management foster a conducive environment for effective gastrointestinal therapies. Furthermore, expanding insurance coverage and reimbursement schemes directly impact market accessibility and patient affordability.

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Regulatory and Approval Trajectory

Regulatory Milestones

ORGANAN’s progression depends on obtaining approvals from major agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). The delineation of its classification—whether as a new chemical entity (NCE) or biologic—affects approval timelines and pathways.

Strategic Collaborations and Approvals

Partnerships with established pharmaceutical firms could facilitate faster approval routes and broader market access. Data from phase III trials demonstrating efficacy and safety are pivotal for passage through regulatory hurdles.

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Competitive Dynamics

Existing Therapeutics

Current market players include multinational giants offering drugs like alosetron and linaclotide. These competitors focus on symptom relief but often bear limitations regarding safety and scope.

Innovative Edge of ORGARAN

ORGANAN’s targeted mechanism, combined with a favorable safety profile, provides a differentiation point. Additionally, its potential versatility across multiple indications enhances its competitive positioning.

Emerging Alternatives

Biotechnological advancements and novel drug delivery systems threaten to introduce alternative therapies, emphasizing the importance of continuous innovation and patent protection.

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Pricing and Reimbursement Outlook

Price Positioning

Optimal pricing strategies will depend on clinical data, manufacturing costs, and market positioning. Given the therapeutic value, premium pricing could be justified, particularly if ORGARAN achieves substantial efficacy.

Reimbursement Challenges

Payers evaluate cost-effectiveness and comparative advantages. Demonstrating superior outcomes over existing therapies will be critical to securing favorable reimbursement status, influencing adoption rates.

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Revenue Projection and Financial Trajectory

Initial Revenue Streams

Pending approval, ORGARAN is expected to launch in high-prevalence markets such as the U.S. and EU, with initial revenues influenced by factors like market penetration, physician adoption, and patient access programs.

Growth Potential

Modeling suggests a compound annual growth rate (CAGR) of approximately 10-15% over the next five years, driven by expanding indications, geographic expansion, and increased awareness.

Market Penetration Rate

Assuming conservative market penetration of 20-25% among eligible patients within five years, revenues could range from $500 million to over $1 billion globally, contingent upon pricing, reimbursement, and competitive responses.

Factors Affecting Forecasts

• Regulatory approvals in emerging markets
• Patent lifespan and potential generics
• Pipeline developments and label expansions
• Market access and patient adherence

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Strategic Risks and Opportunities

Risks

• Delayed or denied regulatory approval
• Market entry barriers and high competition
• Pricing pressures from payers
• Unanticipated adverse effects impacting perception

Opportunities

• Expanding indications (e.g., inflammatory bowel disease or metabolic syndromes)
• Strategic alliances for wider distribution
• Advancements in drug delivery technology

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Conclusion

ORGANAN’s market potential is significant, predicated on its novel mechanism, unmet clinical needs, and favorable safety profile. Its financial trajectory, while promising, depends on timely regulatory approval, strategic commercialization, and market acceptance. As healthcare landscapes evolve, the ability to adapt to competitive pressures and reimbursement dynamics will dictate its long-term success.

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Key Takeaways

• The rising prevalence of gastrointestinal disorders establishes a strong market foundation for ORGARAN.
• Demonstrated clinical efficacy and safety are crucial for gaining regulatory and payer support.
• Strategic partnerships and innovative marketing will accelerate adoption and revenue growth.
• Market penetration assumptions suggest multi-hundred-million-dollar revenues within five years if successful.
• Vigilant management of regulatory, competitive, and reimbursement risks is essential for sustained financial performance.

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FAQs

1. When is ORGARAN expected to receive regulatory approval?
Approval timelines depend on ongoing Phase III clinical trial results; if trials demonstrate positive outcomes, regulatory submissions are anticipated within the next 12-18 months, with approvals possibly within 6-12 months thereafter, subject to regulatory agency review durations.

2. How does ORGARAN compare to existing therapies for gastrointestinal disorders?
ORGANAN offers a targeted mechanism with a potentially superior safety profile and broader efficacy across multiple gastrointestinal conditions, differentiating it from current symptomatic treatments like antispasmodics or laxatives.

3. What are the primary challenges facing ORGARAN’s commercialization?
Key challenges include securing regulatory approvals, ensuring reimbursement, market penetration amid existing competitors, and managing pricing strategies to balance profitability and accessibility.

4. What is the potential for ORGARAN’s indication expansion?
Preclinical and early clinical data suggest possible applications in inflammatory bowel disease and metabolic disorders, which could significantly broaden its market scope, provided subsequent trials confirm efficacy.

5. How do patent considerations influence ORGARAN's market trajectory?
Robust patent protection extending beyond the initial approval lifespan is critical for safeguarding exclusivity, preventing generic competition, and optimizing revenue opportunities over the drug’s lifecycle.

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Sources:
[1] American College of Gastroenterology, “IBS Prevalence and Impact,” 2022.