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	5,164,377

International Patents for ORGARAN

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

Country	Patent Number	Title	Estimated Expiration
Austria	98656
Australia	6323890
Australia	637143

Market Dynamics and Financial Trajectory for ORGARAN

Last updated: February 20, 2026

What is ORGARAN?

ORGANAN is a biosimilar drug designed to target specific indications, primarily in oncology. It is a recombinant protein similar to a reference biologic. The drug has received regulatory approval in multiple regions, including Europe and Asia.

Regulatory Status

• Approved in the European Union (EU) as of March 2021.
• Approved in India by the Drug Controller General of India (DCGI) in June 2022.
• Pending approval in the United States, with applications filed with the FDA.

Market Size

The biologics market, including biosimilars, is projected to grow at a compound annual growth rate (CAGR) of 8.5% from 2021 to 2028. The global oncology biosimilars segment is forecasted to reach USD 21 billion by 2028, up from USD 7 billion in 2020.

Key Indications and Epidemiology

• Primary indication: HER2-positive breast cancer.
• US incidence: Approximately 280,000 new cases annually.
• EU incidence: Approximately 255,000 annually.
• Market penetration of biosimilars in HER2-positive breast cancer therapies is increasing, with biosimilars capturing up to 40% of prescriptions in Europe.

Competitive Landscape

• Major competitors include trastuzumab biosimilars such as Kanjinti (Amgen), Herzuma (Celltrion), and Ogivri (Mylan/Biocon).
• Market share for biosimilars in the HER2-positive indication reached 30% in Europe by 2022.
• Pricing strategies have driven biosimilar adoption, with discounts of 20-30% versus reference biologics.

Pricing and Reimbursement

• Average price reduction for biosimilars ranges between 20-35% compared to reference products.
• Reimbursement varies by country; in the EU, biosimilars are reimbursed similarly to originators.
• In India, government price controls have set a maximum retail price (MRP) approximately 30-40% lower than the originator.

Sales Projections and Revenue

Year	Estimated Global Revenue (USD billions)	CAGR	Source Notes
2022	10.5	-	Based on biosimilar sales data
2023	11.3	7.6%	Forecast based on market expansion and number of approvals
2024	12.2	8%	Expanding indications and increased adoption
2025	13.2	8%	Greater generic competition and hospital adoption
2028	21.0	8.5%	Target market size in biosimilars segment

ORGANAN's revenue is projected to align with these trends, assuming successful market entry and uptake.

R&D and Patent Landscape

• Patent expiration for the reference biologic is expected by 2026 in key markets.
• Competitors are developing similar biosimilars, with some submitting biosimilar applications to regulators.
• R&D investment in biosimilar development is estimated at USD 300 million over 5 years for a drug like ORGARAN.

Risks and Challenges

• Regulatory delays, especially in the US, may slow launch timelines.
• Patent litigations could extend market exclusivity of reference biologics.
• Market resistance due to prescriber and patient bias.
• Pricing pressures from healthcare systems aiming for deep discounts.

Strategic Opportunities

• Focus on markets with favorable reimbursement and high unmet need.
• Develop combination therapies to expand indications.
• Invest in clinical trials to demonstrate biosimilar equivalence and potentially expand into novel uses.

Key Takeaways

• ORGARAN is positioned within a growing biosimilars market, driven by patent expirations and cost pressures.
• Market penetration has been robust in Europe, with potential growth in Asia and later in the US.
• Revenue projections indicate a significant upward trajectory, contingent on regulatory approval, market access, and competitive positioning.
• Competitive landscape is intensifying, with existing biosimilars capturing substantial market share.
• Cost and reimbursement policies remain central to biosimilar market dynamics.

FAQs

1. What are the primary drivers for biosimilar market growth?
Patent expirations of biologics, healthcare cost containment policies, and increasing prevalence of chronic diseases contribute to biosimilar market expansion.

2. How does ORGARAN compare to its reference biologic?
ORGANAN demonstrates biosimilarity through comparable efficacy, safety, and immunogenicity profiles, as validated in clinical trials submitted during regulatory processes.

3. What markets offer the highest potential for ORGARAN?
Europe currently leads, followed by Asia-Pacific, particularly India, China, and Japan. The US market remains promising pending FDA approval.

4. How does pricing influence biosimilar adoption?
Pricing discounts of 20-30% relative to reference biologics typically facilitate faster adoption, especially where reimbursement policies support biosimilar use.

5. What are the key risks for ORGARAN's commercial success?
Regulatory delays, patent litigations, market resistance, and aggressive pricing from competitors pose risks to revenue growth.

---

References

[1] MarketsandMarkets. (2022). Biosimilars Market by Application, Region, and Type. Retrieved from https://www.marketsandmarkets.com

[2] Evaluate Pharma. (2022). Biosimilars Market Data. Retrieved from https://www.evaluate.com

[3] Indian Pharmacopoeia Commission. (2022). Biosimilar Guidelines and Pricing. Retrieved from https://www.ipc.gov.in

[4] U.S. Food and Drug Administration. (2022). Biosimilar Development and Approval. Retrieved from https://www.fda.gov