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
Ireland	903366
Ireland	64121	Sulphated glycosaminoglycuronan with antithrombotic activity
Canada	2026036	GLYCOSAMINO GLYCURONAN SULPHATE AYANT UNE ACTIVITE ANTITHROMBOTIQUE (SULPHATED GLYCOSAMINO GLYCURONAN WITH ANTITHROMBOTIC ACTIVITY)
Portugal	95511	PROCESSO DE PRODUCAO DE GLICOSAMINOGLICURONANO SULFATO E DE COMPOSICOES FARMACEUTICAS
Finland	101152
South Korea	184260

ORGARAN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Heparin-Induced Thrombocytopenia (HIT) Treatment: Focus on Argatroban

Introduction to Heparin-Induced Thrombocytopenia (HIT)

Heparin-induced thrombocytopenia (HIT) is a severe and potentially life-threatening complication that occurs in some patients who receive heparin, a commonly used anticoagulant. This condition is characterized by a significant drop in platelet count and the formation of additional blood clots, leading to high morbidity and mortality rates among hospitalized patients.

Market Overview of HIT Treatment

The HIT treatment market is projected to experience substantial growth over the coming years. Here are some key statistics:

• Current Market Value: The HIT treatment market was valued at US$ 9.8 billion in 2023[1].
• Projected Growth: The market is expected to grow at a Compound Annual Growth Rate (CAGR) of 5% from 2023 to 2033, reaching a valuation of US$ 15.97 billion by the end of the forecast period[1].

Regional Market Dynamics

• United States: The U.S. is anticipated to be a major hub for HIT testing, diagnosis, and treatment. Approximately 12 million patients in the U.S. are administered heparin annually, with about 0.76% of those receiving therapeutic doses of intravenous unfractionated heparin (UFH) developing HIT[1].
• Europe and Asia Pacific: Europe is also a significant market, while the Asia Pacific region is expected to see rapid growth due to increasing prevalence of cardiovascular and acute coronary syndromes[1].

Key Players and Treatment Options

Argatroban: A Key Treatment Option

Argatroban is a direct thrombin inhibitor used for the prophylaxis or treatment of thrombosis in patients with HIT. Here’s how it fits into the market:

• Manufacturer: Pfizer Inc. is one of the prominent manufacturers of argatroban injections for HIT patients[1].
• Dosage and Use: The recommended dosage for argatroban is a 0.75 mg/kg intravenous bolus followed by a 1.75 mg/kg/h intravenous infusion[1].

Other Treatment Options

Other treatments include danaparoid and fondaparinux, which have been shown to have similar effectiveness and safety profiles compared to argatroban[4].

Market Growth Drivers

• Increasing Heparin Administration: The widespread use of heparin in medical settings increases the risk of HIT, thereby driving the demand for effective treatments[1].
• Novel Therapies and Drug Candidates: Companies are investing in the development of new therapies and prescribed drug candidates to expand their market share[1].

Challenges and Opportunities

• Sophisticated Drug Availability: The current lack of sophisticated drugs and therapies presents a significant opportunity for pharmaceutical companies to develop novel treatments for HIT[1].
• Regulatory Environment: The regulatory landscape, including FDA scrutiny and approval processes, can impact the entry and pricing of generic and branded drugs in the market[3].

Financial Performance of Key Players

While the financial performance of companies specifically focused on HIT treatments is not detailed in the sources, the broader pharmaceutical industry dynamics provide some insights:

• Revenue and Profitability: Companies like Pfizer, which manufacture HIT treatments, often report revenue and profitability based on their overall product portfolio. For instance, Pfizer's financial performance is influenced by a wide range of pharmaceutical products, not just those related to HIT[1].

Illustrative Statistics and Quotes

• Market Size and Growth: "The heparin-induced thrombocytopenia (HIT) treatment market is expected to grow fastest in the Asia Pacific due to the increasing prevalence of cardiovascular and acute coronary syndromes, thus boosting the market growth."[1]
• Mortality Rates: "Mortality arising out of the condition is as high as 20%," highlighting the critical need for effective treatments[1].

Regional Opportunities

• South Asia: Countries like India and China offer significant opportunities for the manufacture and distribution of new HIT treatment drugs due to their large populations and increasing incidence of HIT[1].

Competitive Landscape

The HIT treatment market is competitive, with several key players vying for market share:

• Pfizer Inc.: Known for its argatroban and bivalirudin products.
• Alleviare Life Sciences Pvt. Ltd., ANDOZ, GlaxoSmithKline Plc., Eagle Pharmaceuticals Inc., Teva Pharmaceutical Industries Ltd., WEST-WARD, INC.: Other notable players in the HIT treatment landscape[1].

Key Takeaways

• The HIT treatment market is expected to grow significantly, driven by the increasing administration of heparin and the need for effective treatments.
• Argatroban is a key treatment option, with Pfizer Inc. being a major manufacturer.
• The market faces challenges such as the lack of sophisticated drugs, but this also presents opportunities for innovation and growth.
• Regional markets, especially in the Asia Pacific, are expected to see rapid growth.

FAQs

1. What is the current market value of the HIT treatment market?

• The HIT treatment market was valued at US$ 9.8 billion in 2023[1].

2. What is the projected growth rate of the HIT treatment market?

• The market is expected to grow at a CAGR of 5% from 2023 to 2033[1].

3. Which region is expected to be the largest market for HIT treatment?

• The United States is expected to be the largest regional market share in the HIT treatment market[1].

4. What are the common treatment options for HIT?

• Common treatment options include argatroban, danaparoid, and fondaparinux[1][4].

5. What are the key drivers of the HIT treatment market growth?

• The increasing administration of heparin and the development of novel therapies are key drivers of market growth[1].

Cited Sources

1. Future Market Insights: "Heparin-Induced Thrombocytopenia (HIT) Treatment Market 2033"
2. Organigram: "Organigram Reports Fiscal 2023 Results"
3. Federal Trade Commission: "Generic Drug Industry Dynamics"
4. ASH Publications: "Fondaparinux for the treatment of suspected heparin-induced thrombocytopenia"