FRAGMIN Drug Patent Profile

When do Fragmin patents expire, and what generic alternatives are available?

Fragmin is a drug marketed by Pfizer and is included in one NDA.

The generic ingredient in FRAGMIN is dalteparin sodium. There are seven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dalteparin sodium profile page.

Summary for FRAGMIN

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	38
Drug Prices:	Drug price information for FRAGMIN
What excipients (inactive ingredients) are in FRAGMIN?	FRAGMIN excipients list
DailyMed Link:	FRAGMIN at DailyMed

See drug prices for FRAGMIN

Recent Clinical Trials for FRAGMIN

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

Sponsor	Phase
Valeo Pharma Inc	Phase 3
Western University, Canada	Phase 3
Itreas	Phase 3

See all FRAGMIN clinical trials

Pharmacology for FRAGMIN

Drug Class

Anti-coagulant Low Molecular Weight Heparin

US Patents and Regulatory Information for FRAGMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;INJECTION	020287-008	Apr 4, 2002		DISCN	No	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-012	Mar 15, 2022		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-005	Apr 4, 2002		RX	Yes	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-007	Apr 4, 2002		DISCN	No	No
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-009	May 1, 2007		RX	Yes	No

Expired US Patents for FRAGMIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-001	Dec 22, 1994	4,303,651
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-003	Mar 18, 1996	4,303,651
Pfizer	FRAGMIN	dalteparin sodium	INJECTABLE;SUBCUTANEOUS	020287-004	Jan 30, 1998	4,303,651

International Patents for FRAGMIN

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

Country	Patent Number	Title	Estimated Expiration
Denmark	380280
Netherlands	930104
World Intellectual Property Organization (WIPO)	8001383
Canada	1136620	FRAGMENTS D'HEPARINE AYANT UNE ACTIVITE ANTICOAGULANTE SELECTIVE (HEPARIN FRAGMENTS HAVING SELECTIVE ANTICOAGULATION ACTIVITY)
Germany	3068924

FRAGMIN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fragmin (Dalteparin Sodium)

Introduction to Fragmin

Fragmin, also known as Dalteparin sodium, is a low molecular weight heparin (LMWH) used primarily as an anticoagulant to prevent and treat thrombotic disorders. It is one of the key products in the heparin market, particularly notable for its use in preventing deep vein thrombosis (DVT) and pulmonary embolism.

Market Size and Growth

The global heparin market, which includes Fragmin, is projected to grow significantly over the forecast period from 2024 to 2032. The market size is expected to increase from $10.21 billion in 2024 to $14.45 billion by 2032, at a Compound Annual Growth Rate (CAGR) of 4.4%[1].

Key Drivers of Market Growth

Several factors are driving the growth of the heparin market, including Fragmin:

Increasing Prevalence of Cardiovascular Diseases

Cardiovascular diseases are a major driver, as they are the leading cause of death worldwide, accounting for approximately 7.5 million deaths annually. The increasing prevalence of these diseases necessitates the use of anticoagulants like Fragmin[4].

Technological Advancements and R&D Initiatives

Significant investments in research and development (R&D) and the launch of new products are expected to drive market growth. Initiatives to develop synthetic versions of heparin and expand its application areas are particularly noteworthy[1].

Regulatory Approvals and Healthcare Expenditure

Rising regulatory approvals and increased healthcare expenditure, especially in regions like North America and Europe, are also contributing to the market's growth. The strong adoption of technologically advanced products in these regions further fuels the demand for Fragmin[1].

Regional Market Dynamics

North America

North America dominated the heparin market in 2023, with a market size of $5.03 billion. This region is expected to continue its dominance due to the rising prevalence of pulmonary embolism and other cardiovascular diseases, along with the presence of major market players like Pfizer[1].

Europe

Europe is anticipated to be the second-largest market, driven by the strong adoption of advanced products and an increase in individuals suffering from cardiovascular diseases. Well-established R&D facilities and investments in new products are also key factors[1].

Asia Pacific

The Asia Pacific region is expected to register the highest CAGR during the forecast period due to the increasing need for anticoagulants, a strong patient population, and significant healthcare expenditure. The growing applications of LMWH in diverse areas are likely to drive the market’s growth in this region[1].

Financial Performance of Key Players

Pfizer Inc.

Pfizer, the manufacturer of Fragmin, is one of the dominant players in the global heparin market. Despite recent financial challenges, such as a 42% decline in full-year 2023 revenues compared to 2022, largely due to the decline in revenues from COVID-19 related products like Comirnaty and Paxlovid, Pfizer remains a significant force. Excluding these contributions, Pfizer's revenues grew 7% operationally in 2023[2].

Pfizer is focused on cost realignment and expects to deliver at least $4 billion in annual net cost savings by the end of 2024. The company is also committed to enhancing shareholder value through growing dividends, reinvesting in the business, and making share repurchases after de-leveraging the balance sheet[3].

Competitive Landscape

The global heparin market is characterized by the dominance of a few key companies, including Pfizer Inc., Baxter, and Sanofi-Aventis. Pfizer generates significant revenue through Fragmin, while other players like Baxter and Sanofi have their own established products in the market. Emerging players such as Opocrin S.p.A. and Aspen Holdings are also expected to expand their market presence in the coming years[1].

Challenges and Restraints

Raw Material Shortages

One of the major constraints for the heparin market, including Fragmin, is the limited availability of raw materials. Most unfractionated heparin (UFH) and LMWH are produced from porcine mucosa, which is sourced solely from the pork industry. This limitation can impact production and supply chain stability[1].

Safety Concerns

Safety concerns related to animal-derived products also pose a challenge. The risk of contamination and the need for stringent quality control measures can affect market growth[1].

Future Outlook

The future outlook for Fragmin and the broader heparin market is positive, driven by increasing demand for anticoagulants, technological advancements, and expanding application areas. Here are some key points to consider:

• Growing Demand: The increasing prevalence of cardiovascular diseases and the need for effective anticoagulants will continue to drive demand for Fragmin.
• R&D Initiatives: Ongoing R&D efforts, particularly in synthetic heparin, will open new avenues for market growth.
• Regional Expansion: The Asia Pacific region is expected to be a significant growth driver due to its large patient population and increasing healthcare expenditure.

Key Takeaways

• The global heparin market, including Fragmin, is projected to grow at a CAGR of 4.4% from 2024 to 2032.
• North America and Europe are expected to be the dominant regions, with Asia Pacific showing the highest growth potential.
• Pfizer Inc., through its product Fragmin, remains a key player in the market.
• Challenges include raw material shortages and safety concerns related to animal-derived products.
• R&D initiatives and expanding application areas are expected to drive market growth.

FAQs

Q: What is the projected market size of the global heparin market by 2032? A: The global heparin market is projected to grow to $14.45 billion by 2032[1].

Q: Which region is expected to dominate the heparin market during the forecast period? A: North America is expected to dominate the heparin market during the forecast period[1].

Q: What are the main drivers of the heparin market growth? A: The main drivers include the increasing prevalence of cardiovascular diseases, technological advancements, and R&D initiatives[1].

Q: Which company is the primary manufacturer of Fragmin? A: Pfizer Inc. is the primary manufacturer of Fragmin (Dalteparin sodium)[1].

Q: What are the challenges faced by the heparin market? A: The challenges include raw material shortages, safety concerns related to animal-derived products, and potential regulatory impacts[1].

Sources

1. Fortune Business Insights, Heparin Market Size, Share & Global Forecast Report [2030].
2. Pfizer, Pfizer Reports Full-Year 2023 Results and Reaffirms Full-Year 2024 Guidance.
3. Krause Fund Research, Pfizer (PFE).
4. iHealthcareAnalyst, Global Antithrombotic Drugs Market.