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INJECTAFER Drug Patent Profile

When do Injectafer patents expire, and when can generic versions of Injectafer launch?

Injectafer is a drug marketed by Am Regent and is included in one NDA. There are six patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-one patent family members in thirty-two countries.

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

DrugPatentWatch^® Generic Entry Outlook for Injectafer

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 31, 2026. This may change due to patent challenges or generic licensing.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for INJECTAFER

International Patents:	71
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	21
Patent Applications:	47
Drug Prices:	Drug price information for INJECTAFER
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for INJECTAFER
What excipients (inactive ingredients) are in INJECTAFER?	INJECTAFER excipients list
DailyMed Link:	INJECTAFER at DailyMed

See drug prices for INJECTAFER

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

Constraining patent/regulatory exclusivity:

TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY

NDA:

203565

Dosage:

INJECTABLE;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 INJECTAFER

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

Sponsor	Phase
Baylor College of Medicine	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
M.D. Anderson Cancer Center	Phase 2

See all INJECTAFER clinical trials

Pharmacology for INJECTAFER

Drug Class	Parenteral Iron Replacement Phosphate Binder
Mechanism of Action	Phosphate Chelating Activity

Paragraph IV (Patent) Challenges for INJECTAFER

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INJECTAFER	Injection	ferric carboxymaltose	500 mg/10 mL	203565	1	2024-02-22
INJECTAFER	Injection	ferric carboxymaltose	100 mg/2 mL	203565	1	2022-09-23
INJECTAFER	Injection	ferric carboxymaltose	1 g/20 mL	203565	1	2022-02-15
INJECTAFER	Injection	ferric carboxymaltose	750 mg/15 mL	203565	1	2019-03-27

US Patents and Regulatory Information for INJECTAFER

INJECTAFER is protected by twenty-six US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF IRON DEFICIENCY IN ADULT PATIENTS WITH HEART FAILURE AND NEW YORK HEART ASSOCIATION CLASS II/III TO IMPROVE EXERCISE CAPACITY.

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
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes			Y	Y
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021		RX	Yes	Yes
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013		RX	Yes	Yes

Expired US Patents for INJECTAFER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-003	Apr 28, 2021
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-002	Oct 8, 2020
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-001	Jul 25, 2013
Am Regent	INJECTAFER	ferric carboxymaltose	SOLUTION;INTRAVENOUS	203565-004	Feb 4, 2022

International Patents for INJECTAFER

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

Country	Patent Number	Title	Estimated Expiration
China	1705682	Water-soluble iron-carbohydrate complexes, production thereof, and medicaments containing said complexes
China	100480275
Denmark	2287204
Norway	20052410
Spain	2364136
World Intellectual Property Organization (WIPO)	2004037865
Cyprus	1118780

Supplementary Protection Certificates for INJECTAFER

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1554315	C01554315/01	Switzerland		PRODUCT NAME: EISEN ALS EISENCARBOXYMALTOSE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 57851 10.11.2022

INJECTAFER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for INJECTAFER

Introduction

INJECTAFER, a leading intravenous iron drug, has been a significant player in the global intravenous iron drugs market. This article delves into the market dynamics, financial performance, and future outlook of INJECTAFER, highlighting its impact on the pharmaceutical industry.

Market Size and Growth

The global intravenous iron drugs market, in which INJECTAFER is a key product, is experiencing robust growth. As of 2023, the market size was valued at approximately $3.24 billion and is projected to reach $7.41 billion by 2033, growing at a CAGR of 8.62% from 2024 to 2033[1][4].

Product Performance

INJECTAFER, developed by Vifor Pharma (now part of Vifor Pharma Group), has shown remarkable growth. In 2018, the net sales of Ferinject®/Injectafer® increased by 23.8% compared to the previous year, contributing significantly to Vifor Pharma's overall revenue[2].

Regulatory Approvals and Product Launches

Regulatory approvals have been a crucial factor in the market expansion of INJECTAFER. For instance, the FDA’s approval of INJECTAFER for specific conditions, including its recent approval for pediatric patients with Iron Deficiency Anemia (IDA) who are unresponsive to oral iron, has been pivotal in driving market growth[1][4].

Market Share and Segmentation

North America holds the largest market share for intravenous iron drugs, with INJECTAFER being a leading product in this region. The ferric carboxymaltose segment, which includes INJECTAFER, accounted for a market share of 48% in 2023. The chronic kidney disease segment is the largest application area, accounting for a revenue share of 35% in 2023[1][4].

Regional Performance

• North America: This region dominates the market due to the increasing approvals and launches of new intravenous iron drugs, including INJECTAFER. The U.S. market, in particular, has seen significant growth driven by FDA approvals[1][4].
• Asia Pacific: This region is expected to exhibit the fastest growth during the forecast period, driven by the expansion of major industry players, government healthcare initiatives, and a high incidence of iron deficiency anemia in countries like China and India[1][4].

Financial Highlights

Vifor Pharma's financial performance has been strong, with net sales increasing by 22.7% to CHF 1,584.6 million in 2018. The EBITDA for the same year increased to CHF 391.5 million, reflecting a 39.7% growth. The success of Ferinject®/Injectafer® has been a key driver of this financial performance[2].

Drivers of Growth

Several factors are driving the growth of INJECTAFER and the broader intravenous iron drugs market:

• Increasing Prevalence of Iron Deficiency Anemia: The rising incidence of IDA globally is a significant driver, as it increases the demand for effective treatment options[4].
• Government Initiatives and Healthcare Development: Government initiatives aimed at improving healthcare infrastructure, especially in the Asia Pacific region, are contributing to market growth[4].
• Research and Development: Continuous innovation in iron formulations, focusing on improved safety and convenience, is another key driver[4].

Challenges and Restraints

Despite the growth, the market faces some challenges:

• Potential for Adverse Reactions: The risk of adverse reactions or side effects associated with intravenous iron administration is a notable restraint[4].

Competitive Landscape

The intravenous iron drugs market is highly competitive, with key players focusing on research and development, strategic collaborations, and regulatory approvals. Vifor Pharma, through its product INJECTAFER, remains a market leader, leveraging its expertise in research, development, and commercialization to maintain its position[2][4].

Future Outlook

The future outlook for INJECTAFER and the intravenous iron drugs market is promising. With a projected CAGR of 8.62% from 2024 to 2033, the market is expected to continue its robust expansion. The Asia Pacific region is anticipated to be a significant growth driver, and ongoing innovations in iron formulations will further bolster market growth[1][4].

Key Takeaways

• INJECTAFER is a leading intravenous iron drug with significant market share.
• The global intravenous iron drugs market is expected to grow from $3.24 billion in 2023 to $7.41 billion by 2033.
• Regulatory approvals and product launches are critical for market expansion.
• North America dominates the market, but the Asia Pacific region is expected to grow the fastest.
• Increasing prevalence of iron deficiency anemia and government healthcare initiatives are key drivers of growth.

FAQs

1. What is the current market size of the global intravenous iron drugs market? The global intravenous iron drugs market size was evaluated at US$ 3.24 billion in 2023[1].

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

3. Which region holds the largest market share for intravenous iron drugs? North America holds the largest market share, with a 52% share in 2023[1].

4. What are the key drivers of growth for INJECTAFER and the intravenous iron drugs market? Key drivers include the increasing prevalence of iron deficiency anemia, government healthcare initiatives, and ongoing innovations in iron formulations[4].

5. What are the potential restraints for the intravenous iron drugs market? The potential for adverse reactions or side effects associated with intravenous iron administration is a notable restraint[4].

Citations

1. Precedence Research - "Intravenous Iron Drugs Market Size to Worth Around US$ 7.41 Billion by 2033"[1].
2. Vifor Pharma Ltd. - "Annual Report 2018"[2].
3. ResearchAndMarkets.com - "Global Intravenous (IV) Iron Drugs Market Report 2021"[3].
4. SkyQuest - "Intravenous Iron Drugs Market Size, Share, Trends & Forecast | 2031"[4].
5. GlobeNewswire - "Iron Deficiency Injectable Market Size Is Expected To Reach $20.68 Billion by 2028"[5].