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MONOFERRIC Drug Patent Profile

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

Monoferric is a drug marketed by Pharmacosmos and is included in one NDA. There are five patents protecting this drug.

This drug has fifty-nine patent family members in twenty-five countries.

The generic ingredient in MONOFERRIC is ferric derisomaltose. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ferric derisomaltose profile page.

DrugPatentWatch^® Generic Entry Outlook for Monoferric

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 14, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for MONOFERRIC

International Patents:	59
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	10
Drug Prices:	Drug price information for MONOFERRIC
What excipients (inactive ingredients) are in MONOFERRIC?	MONOFERRIC excipients list
DailyMed Link:	MONOFERRIC at DailyMed

See drug prices for MONOFERRIC

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for MONOFERRIC

Constraining patent/regulatory exclusivity:

8,815,301

NDA:

208171

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for MONOFERRIC

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

Sponsor	Phase
Oregon Health and Science University	Early Phase 1
Alberta Health Services, Calgary	Phase 3
AHS Cancer Control Alberta	Phase 3

See all MONOFERRIC clinical trials

US Patents and Regulatory Information for MONOFERRIC

MONOFERRIC is protected by five US patents.

This potential generic entry date is based on patent 8,815,301.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes	11,633,489
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-001	Jan 16, 2020		DISCN	Yes	No	11,633,489
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-003	Jan 16, 2020		RX	Yes	Yes	10,414,831		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No	8,815,301		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-001	Jan 16, 2020		DISCN	Yes	No	10,414,831		Y	Y
Pharmacosmos	MONOFERRIC	ferric derisomaltose	SOLUTION;INTRAVENOUS	208171-002	Jan 16, 2020		DISCN	Yes	No	11,851,504		Y	Y

International Patents for MONOFERRIC

When does loss-of-exclusivity occur for MONOFERRIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Japan

Lithuania

Mexico

New Zealand

Philippines

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering MONOFERRIC around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2756580	COMPOSE OLIGOSACCHARIDE STABLE ASSOCIE AU FER (A STABLE IRON OLIGOSACCHARIDE COMPOUND)
Mexico	2011009936	UN COMPUESTO DE OLIGOSACARIDO DE HIERRO ESTABLE. (A STABLE IRON OLIGOSACCHARIDE COMPOUND.)
China	116999459	用于治疗胎儿或婴儿铁缺乏的铁碳水化合物复合物 (Iron carbohydrate complexes for treatment of iron deficiency in fetuses or infants)
Serbia	61104	OLIGOSAHARID I POSTUPAK NJEGOVE PRIPREME (AN OLIGOSACCHARIDE AND A PROCESS FOR PREPARATION THEREOF)
South Africa	201707463	IRON CARBOHYDRATE COMPLEX FOR TREATMENT OF IRON DEFICIENCY OF A FETUS OR AN INFANT
Eurasian Patent Organization	201190214	СТАБИЛЬНОЕ ЖЕЛЕЗО-ОЛИГОСАХАРИДНОЕ СОЕДИНЕНИЕ

Supplementary Protection Certificates for MONOFERRIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2411053	C02411053/01	Switzerland		PRODUCT NAME: FERRUM (III) UT FERRI ISOMALTOSIDUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67001 26.08.2019

MONOFERRIC Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Monoferric

Introduction to Monoferric

Monoferric, also known as iron isomaltose, is an intravenous iron replacement therapy used to treat iron deficiency in adult patients when oral iron preparations are ineffective or cannot be administered, or when there is a clinical need for rapid delivery of iron. Here, we will delve into the market dynamics and financial trajectory of Monoferric.

Global Intravenous Iron Drugs Market Overview

The global intravenous iron drugs market, within which Monoferric operates, is experiencing significant growth. As of 2023, the market size was estimated at approximately USD 3.24 billion and is projected to reach USD 7.41 billion by 2033, growing at a CAGR of 8.62% from 2024 to 2033[1][4].

Market Segments and Share

Monoferric falls under the ferric carboxymaltose segment, which accounted for a 48% market share in 2023. This segment is one of the dominant players in the intravenous iron drugs market due to its efficacy and safety profile[1][4].

Regional Performance

The North American market holds a significant share, with 52% of the global intravenous iron drugs market in 2023. However, the Asia Pacific region is expected to expand at the fastest CAGR during the forecast period, driven by increasing healthcare infrastructure and awareness of iron deficiency anemia[1][4].

Application and Disease Indications

Monoferric is primarily used in the treatment of chronic kidney disease, which accounted for a 35% revenue share in 2023. Other significant applications include inflammatory bowel disease and cancer, contributing to the overall growth of the intravenous iron drugs market[1][4].

Regulatory Approvals and Product Launches

Regulatory approvals play a crucial role in the market expansion of intravenous iron drugs. For instance, the FDA’s approval of drugs like INJECTAFER has been pivotal in driving market growth. Similarly, Monoferric’s approval and subsequent market launches in various regions have contributed to its market presence[1].

Industrial Developments and Partnerships

In September 2022, Pharmacosmos A/S sold the rights to market Monoferric in India and Nepal to Zydus Lifesciences, expanding its reach in these regions. Such strategic partnerships are essential for the growth and distribution of Monoferric[3].

Technological Advancements

The intravenous iron drugs market is witnessing technological advancements, including nanoparticle-based formulations and innovative infusion systems. These advancements enhance iron absorption, minimize side effects, and offer targeted delivery mechanisms, which are likely to boost the adoption of Monoferric and similar products[4].

Financial Incentives and Patient Assistance Programs

To make Monoferric more accessible, patient assistance programs such as the Monoferric Patient Solutions® Program offer significant savings. Patients can receive up to $2,000 per dose in out-of-pocket expenses, which can be applied to their deductible, copay, or coinsurance obligations. This program helps in reducing the financial burden on patients and can increase the market penetration of Monoferric[5].

Competitive Landscape

The intravenous iron drugs market is highly competitive, with major players like Vifor Pharma, AMAG Pharmaceuticals, Daiichi Sankyo Company, Ltd., and Sanofi. Emerging players such as Rockwell Medical and Pharmacosmos are also making significant strides through collaborations and product diversification. Monoferric, being a product of Pharmacosmos, benefits from these competitive strategies[4].

COVID-19 Impact

The COVID-19 pandemic had a restraining effect on the market growth due to supply chain disruptions. However, as the healthcare sector recovers, the demand for intravenous iron drugs, including Monoferric, is expected to rebound and continue its growth trajectory[3].

Key Statistics and Projections

• Market Size: The global intravenous iron drugs market is expected to grow from USD 3.24 billion in 2023 to USD 7.41 billion by 2033[1].
• CAGR: The market is projected to grow at a CAGR of 8.62% from 2024 to 2033[1].
• Regional Growth: Asia Pacific is expected to expand at the fastest CAGR during the forecast period[1].
• Segment Share: Ferric carboxymaltose segment, which includes Monoferric, held a 48% market share in 2023[1].

Illustrative Statistics

• Over 3 million people in the U.S. are affected by anemia, contributing to the demand for intravenous iron therapies like Monoferric[4].
• Approximately 2.8 million people visited physician offices, and around 890,000 visited emergency departments with anemia as a primary diagnosis in the U.S., further highlighting the market potential[4].

Quotes from Industry Experts

"New product launches and approvals are critical for market expansion," notes a report by Precedence Research, emphasizing the importance of regulatory approvals in driving market growth for drugs like Monoferric[1].

Key Takeaways

• Monoferric operates within a growing global intravenous iron drugs market expected to reach USD 7.41 billion by 2033.
• The drug benefits from technological advancements and strategic partnerships.
• Regulatory approvals and patient assistance programs are key drivers of its market presence.
• The Asia Pacific region is expected to be a significant growth area.
• Monoferric is primarily used in treating chronic kidney disease and other conditions.

Frequently Asked Questions

1. What is the projected market size of the global intravenous iron drugs market by 2033? The global intravenous iron drugs market is expected to reach around USD 7.41 billion by 2033[1].

2. What is the CAGR of the global intravenous iron drugs market from 2024 to 2033? The market is projected to grow at a CAGR of 8.62% from 2024 to 2033[1].

3. Which segment does Monoferric belong to, and what is its market share? Monoferric belongs to the ferric carboxymaltose segment, which held a 48% market share in 2023[1].

4. What are the primary applications of Monoferric? Monoferric is primarily used in the treatment of chronic kidney disease, inflammatory bowel disease, and cancer[1][4].

5. How do patient assistance programs impact the market for Monoferric? Patient assistance programs like the Monoferric Patient Solutions® Program offer significant savings, making the drug more accessible and increasing its market penetration[5].

Cited Sources:

1. Precedence Research, "Intravenous Iron Drugs Market Size to Worth Around US$ 7.41 Billion by 2033," Biospace, July 12, 2024.
2. FDA, "FY 2020 PDUFA Performance Report," FDA, June 5, 2020.
3. Business Research Insights, "Anemia Drugs Market Size, Trend, Growth Analysis, 2032," Business Research Insights, November 4, 2024.
4. Grand View Research, "Intravenous Iron Drugs Market Size And Share Report, 2030," Grand View Research.
5. Monoferric Patient Solutions, "Patients & Caregivers - Monoferric Patient Solutions® Program," Monoferric Patient Solutions.