FERAHEME Drug Patent Profile

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

Feraheme is a drug marketed by Covis and is included in one NDA.

The generic ingredient in FERAHEME is ferumoxytol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ferumoxytol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Feraheme

A generic version of FERAHEME was approved as ferumoxytol by SANDOZ on January 15^th, 2021.

Summary for FERAHEME

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	9
Clinical Trials:	60
Drug Prices:	Drug price information for FERAHEME
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FERAHEME
What excipients (inactive ingredients) are in FERAHEME?	FERAHEME excipients list
DailyMed Link:	FERAHEME at DailyMed

See drug prices for FERAHEME

Recent Clinical Trials for FERAHEME

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

Sponsor	Phase
National Institutes of Health (NIH)	Early Phase 1
Lipella Pharmaceuticals, Inc.	Early Phase 1
Christopher J Chermansky, MD	Early Phase 1

See all FERAHEME clinical trials

Pharmacology for FERAHEME

Drug Class

Parenteral Iron Replacement

Paragraph IV (Patent) Challenges for FERAHEME

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FERAHEME	Injection	ferumoxytol	30 mg/mL, 17 mL single-use vials	022180	1	2015-12-04

US Patents and Regulatory Information for FERAHEME

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009	AB	RX	Yes	Yes

Expired US Patents for FERAHEME

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009
Covis	FERAHEME	ferumoxytol	SOLUTION;INTRAVENOUS	022180-001	Jun 30, 2009

EU/EMA Drug Approvals for FERAHEME

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Takeda Pharma A/S	Rienso	ferumoxytol	EMEA/H/C/002215 Rienso is indicated for the intravenous treatment of iron-deficiency anaemia in adult patients with chronic kidney disease (CKD).The diagnosis of iron deficiency must be based on appropriate laboratory tests (see section 4.2).	Withdrawn	no	no	no	2012-06-15

International Patents for FERAHEME

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

Country	Patent Number	Title	Estimated Expiration
Austria	446108
Japan	2011046752	HEAT STABLE COLLOIDAL IRON OXIDE COATED WITH REDUCED CARBOHYDRATE AND CARBOHYDRATE DERIVATIVE
Denmark	1169062

Supplementary Protection Certificates for FERAHEME

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1169062	C300558	Netherlands		PRODUCT NAME: FERUMOXYTOL IN IEDERE DOOR HET BASISOCTROOI BESCHERMDE VORM; REGISTRATION NO/DATE: EU/1/12/774/001-002 20120615
1169062	C01169062/01	Switzerland		PRODUCT NAME: FERUMOXYTOL; REGISTRATION NO/DATE: SWISSMEDIC 62033 17.08.2012
1169062	2012C/052	Belgium		PRODUCT NAME: FERUMOXYTOL; AUTHORISATION NUMBER AND DATE: EU/1/12/774/001 20120620

FERAHEME Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Feraheme

Introduction to Feraheme

Feraheme, also known as ferumoxytol, is an intravenous iron replacement therapy developed by AMAG Pharmaceuticals. It is primarily used to treat iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Here, we delve into the market dynamics and financial trajectory of Feraheme, highlighting its growth, challenges, and strategic initiatives.

Market Size and Growth

The global intravenous iron drugs market, which includes Feraheme, is projected to expand significantly. By 2028, the market is expected to reach USD 4.2 billion, growing at a Compound Annual Growth Rate (CAGR) of 8.5% from 2021 to 2028[1].

Key Market Drivers

Several factors are driving the demand for Feraheme and other intravenous iron drugs:

• Increasing Prevalence of Chronic Diseases: Conditions such as CKD, cancer, inflammatory bowel diseases, and diabetes are on the rise, leading to a higher incidence of IDA. This increase in chronic diseases is a major driver for the market[1].
• COVID-19 Impact: The COVID-19 pandemic has exacerbated kidney function loss among patients, further increasing the demand for iron replacement therapies like Feraheme[1].
• Novel Formulations and Expanded Indications: The introduction of new formulations and potential label expansions for Feraheme are expected to boost market demand[1].

Market Segmentation

Product Segmentation

Feraheme is part of the ferric carboxymaltose segment, which accounted for the largest revenue share in 2020. This segment's high revenue is largely due to the success of products like Ferinject/Injectafer in key markets[1].

Application Segmentation

The Chronic Kidney Disease (CKD) segment dominates the market, driven by the high prevalence of CKD and the frequent occurrence of IDA among CKD patients. Feraheme is primarily indicated for this segment, making it a significant player[1].

Financial Performance and Projections

Revenue and Sales

Feraheme has been on a solid growth trajectory. AMAG Pharmaceuticals has focused on advancing Feraheme across various growth opportunities, including increasing market share in the U.S., pursuing broader label expansions, and expanding geographically[4].

In 2012, AMAG announced plans to realign its operating cost structure to focus on Feraheme's growth. This included reducing workforce and operating expenses to lower costs associated with the manufacturing of Feraheme[4].

Strategic Acquisitions and Expansion

The acquisition of Lumara Health by AMAG Pharmaceuticals in 2014 was a strategic move to expand into the women's health segment, which includes a large pool of patients with IDA. This acquisition was expected to be immediately accretive to adjusted earnings per share, with projected combined 2015 product sales of $350 million and cost synergies of at least $20 million per year[2][3].

Financial Guidance and Projections

Following the Lumara Health acquisition, AMAG expected to have approximately $100 million in cash and 25.2 million basic shares outstanding. The transaction was financially compelling, with anticipated annualized net sales of $180 million and EBITDA of $110 million for Makena and Lumara Health's maternal health business[2][3].

Competitive Landscape and Strategic Initiatives

Market Competition

The intravenous iron replacement market is competitive, with other players like iron dextran and iron sucrose. However, Feraheme's unique formulation and expanding indications position it favorably in the market[1].

Strategic Initiatives

AMAG has undertaken several strategic initiatives to drive Feraheme's growth:

• Label Expansion: Efforts to expand Feraheme's label beyond CKD to include all patients with IDA could significantly increase its market share[2][3].
• Geographic Expansion: International launches and expansion into new markets are key priorities for AMAG[4].
• Cost Optimization: Realignment of operating costs to focus on Feraheme's growth and reduce manufacturing expenses has been a strategic focus[4].

Regulatory Environment

The regulatory environment has been favorable for Feraheme. For instance, the Drug Quality and Security Act, enacted in 2013, provides strong protection for patient safety and clarifies FDA's authority, which has supported the growth of Feraheme and other pharmaceutical products[3].

Leadership and Operational Structure

Following the acquisition of Lumara Health, AMAG integrated Lumara Health's commercial operations as a separate business unit, reporting directly to AMAG's CEO, William Heiden. This integration has helped in leveraging the acquired commercial sales force to drive Feraheme's growth in new therapeutic areas[2][3].

Key Takeaways

• Market Growth: The intravenous iron drugs market, including Feraheme, is expected to grow significantly, driven by increasing chronic diseases and COVID-19 impacts.
• Financial Performance: Feraheme has been on a solid growth trajectory, with strategic acquisitions and cost optimization initiatives supporting its financial performance.
• Strategic Initiatives: Label expansion, geographic expansion, and integration of new commercial platforms are key strategies driving Feraheme's market presence.
• Regulatory Support: Favorable regulatory environments have supported the growth of Feraheme and other pharmaceutical products.

FAQs

What is Feraheme used for?

Feraheme is used to treat iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

What are the key drivers of the intravenous iron drugs market?

Key drivers include the increasing prevalence of chronic diseases, the impact of COVID-19 on kidney function, and the introduction of novel formulations and expanded indications.

How has AMAG Pharmaceuticals supported the growth of Feraheme?

AMAG has focused on advancing Feraheme through market share increases, label expansions, geographic expansion, and strategic acquisitions like the Lumara Health acquisition.

What is the projected market size for intravenous iron drugs by 2028?

The global intravenous iron drugs market is expected to reach USD 4.2 billion by 2028, growing at a CAGR of 8.5% from 2021 to 2028.

How has the regulatory environment impacted Feraheme?

The regulatory environment, particularly the Drug Quality and Security Act, has provided strong protection for patient safety and supported the growth of Feraheme.

Sources

1. ResearchAndMarkets.com: Global Intravenous Iron Drugs Market Size, Share & Trends Analysis Report by Product (Iron Dextran, Iron Sucrose, Ferric Carboxymaltose), by Application (Chronic Kidney Disease, Inflammatory Bowel Disease, Cancer), by Region, and Segment Forecasts, 2021-2028.
2. FiercePharma: AMAG Pharmaceuticals to Acquire Lumara Health Maternal Health Business.
3. FierceBiotech: AMAG Pharmaceuticals to Acquire Lumara Health Maternal Health Business.
4. FiercePharma: AMAG Pharmaceuticals Realigns Operating Cost Structure to Focus on Continued Feraheme.