Epoetin alfa - Biologic Drug Details

Summary for epoetin alfa

Tradenames:	2
High Confidence Patents:	5
Applicants:	2
BLAs:	2
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for epoetin alfa
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for epoetin alfa

Recent Clinical Trials for epoetin alfa

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Yonsei University	Phase 4
Second Xiangya Hospital of Central South University	Phase 4
Health Research Council, New Zealand	Phase 3

See all epoetin alfa clinical trials

Recent Litigation for epoetin alfa

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Upsher-Smith Laboratories, LLC v. Xiamen LP Pharmaceutical Co., Ltd.	2023-02-23
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN LTD.	2023-01-19
JAZZ PHARMACEUTICALS IRELAND LIMITED v. LUPIN INC.	2021-07-28

See all epoetin alfa litigation

Pharmacology for epoetin alfa

Physiological Effect	Increased Erythroid Cell Production
Established Pharmacologic Class	Erythropoiesis-stimulating Agent
Chemical Structure	Erythropoietin

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for epoetin alfa Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for epoetin alfa Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	5,441,868	2012-08-15	Company disclosures
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	5,547,933	2013-08-20	Company disclosures
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	5,618,698	2003-12-13	Company disclosures
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	5,756,349	2015-05-26	Company disclosures
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	5,955,422	2016-09-21	Company disclosures
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234	5,441,868	2012-08-15	Company disclosures
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234	5,547,933	2013-08-20	Company disclosures

3) Low Certainty: US Patents for epoetin alfa Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	10,016,338	2033-03-11	Patent claims search
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	10,092,703	2039-02-26	Patent claims search
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	10,105,389	2036-04-01	Patent claims search
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	10,112,981	2027-08-21	Patent claims search
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	10,117,943	2039-02-26	Patent claims search
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	10,179,770	2039-02-26	Patent claims search
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234	10,195,188	2036-06-13	Patent claims search

International Patents for epoetin alfa

Country	Patent Number	Estimated Expiration
Saudi Arabia	92130214
Japan	H0217156
Australia	2042192
Hungary	T40694
China	1016795
Cyprus	1643
New Zealand	210501

Supplementary Protection Certificates for epoetin alfa

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300075	Netherlands		PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001 20010608
01C0050	France		PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001 20010608
10199059	Germany		PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001-030 20010608
SPC/GB01/055	United Kingdom		PRODUCT NAME: DARBEPOETIN ALFA; REGISTERED: UK EU/1/01/185/001-030 20010608

Market Dynamics and Financial Trajectory for Epoetin Alfa

Introduction to Epoetin Alfa

Epoetin alfa is a biologic drug that mimics the action of erythropoietin, a natural hormone produced by the kidneys that stimulates the production of red blood cells. It is widely used to treat anemia associated with chronic kidney disease, cancer, and other conditions.

Market Size and Growth

The global erythropoietin drugs market, led by epoetin alfa, is projected to experience significant growth over the next decade. According to Transparency Market Research, the market is estimated to reach USD 14.3 billion by 2034, growing at a Compound Annual Growth Rate (CAGR) of 3.8% from 2024 to 2034[1].

Dominant Market Segment

Epoetin alfa holds a leading position in the erythropoietin drugs market due to its widespread use and established therapeutic efficacy. The epoetin-alfa segment is expected to maintain its dominance during the forecast period, driven by its high usage rate in alleviating anemia in patients with cancer and chronic renal failure[4].

Key Market Drivers

Several factors are driving the growth of the erythropoietin drugs market, including:

Increasing Prevalence of Chronic Diseases

The rising prevalence of chronic kidney diseases and cancer-related anemia globally is a significant driver. These conditions often require erythropoietin therapy to manage anemia, thereby increasing demand for epoetin alfa[1].

Growing Adoption of Biosimilars

Biosimilars, which are cost-effective alternatives to biologics, are gaining traction worldwide. This trend is expected to drive market competition and reduce costs, making erythropoietin therapy more accessible to patients[1].

Technological Advancements

Advancements in drug delivery systems and precision medicine are optimizing treatment efficacy and minimizing adverse effects. These technological improvements are enhancing the appeal of epoetin alfa and other erythropoietin drugs[1].

Expanding Indications

Erythropoietin drugs, including epoetin alfa, are being explored for use beyond anemia management, such as in oncology and rheumatology. This expansion of indications is further boosting market growth[1].

Market Segmentation

The global erythropoietin drugs market is segmented by product type, application, and region.

By Product Type

• Epoetin Alfa
• Epoetin Beta
• Darbepoetin Alfa
• Others

The epoetin-alfa segment currently dominates the market and is expected to continue its lead due to its high usage rate[4].

By Application

• Cancer
• Renal Disease
• Hematology
• Neurology
• Others

The renal disease segment leads the market, driven by the high prevalence of anemia associated with chronic kidney diseases[1].

By Region

• North America
• Latin America
• Asia Pacific
• Europe
• Middle East & Africa

North America dominates the global market due to the presence of several approved and commercialized erythropoietin biosimilars. However, Asia-Pacific and LAMEA regions offer promising growth opportunities as they are less explored compared to North America and Europe[4].

Financial Trajectory

The financial trajectory of the erythropoietin drugs market, particularly for epoetin alfa, is robust. Here are some key financial indicators:

Current Market Size

The erythropoietin market was valued at $17.29 billion in 2023 and is expected to grow to $19.25 billion in 2024 at a CAGR of 11.4%[3].

Projected Growth

By 2028, the market is forecasted to reach $30.92 billion, growing at a CAGR of 12.6% from 2023 to 2028. This growth is driven by market competition, the impact of biosimilars, disease prevalence projections, healthcare policy changes, and emerging markets[3].

Cost-Effectiveness

Economic evaluations have shown mixed results regarding the cost-effectiveness of epoetin alfa. However, studies suggest that when survival gains are assumed, the cost per quality-adjusted life-year (QALY) can be relatively low, ranging from £13,000 to £28,000. Without assumed survival gains, the cost per QALY can be significantly higher[5].

Regulatory and Competitive Landscape

Regulatory Reforms

Ongoing regulatory reforms aimed at streamlining approval processes for biosimilars and biologics are fostering market competition and driving down costs. This makes erythropoietin therapy more accessible to patients globally[1].

Competitive Market

The market is highly competitive, with local and multinational players investing in research and development to address unmet medical needs. Countries like China and India are witnessing significant market growth as these regions are less explored compared to North America and Europe[1].

Clinical Efficacy and Safety

Epoetin alfa has been shown to be highly effective in various clinical settings:

Chronic Kidney Disease

Studies have demonstrated that epoetin alfa significantly improves hemoglobin levels and quality of life in patients with chronic kidney disease. It also reduces the need for blood transfusions[2].

Cancer-Related Anemia

Epoetin alfa is effective in treating anemia in cancer patients, improving hematocrit levels and reducing transfusion requirements[2].

Off-Label Uses

Epoetin alfa is used off-label for conditions such as low-risk myelodysplastic syndromes with symptomatic anemia and as an alternative for patients who refuse red blood cell transfusions[2].

Safety Considerations

While epoetin alfa is effective, it comes with several safety considerations:

Cardiovascular Risks

There is an elevated risk of cardiovascular events, including mortality, myocardial infarction, stroke, and venous thromboembolism, especially when hemoglobin levels are raised above the target of 11 g/dL[2].

Cancer-Related Risks

Increased mortality, tumor progression, and recurrence are observed in cancer patients treated with epoetin alfa. It should be used cautiously in this population[2].

Hypertension and Seizures

Patients should be monitored for hypertension and neurological symptoms indicative of seizures, particularly those with chronic kidney disease[2].

Key Takeaways

• The global erythropoietin drugs market, led by epoetin alfa, is projected to reach USD 14.3 billion by 2034.
• Epoetin alfa dominates the market due to its widespread use and therapeutic efficacy.
• Key drivers include the increasing prevalence of chronic diseases, growing adoption of biosimilars, and technological advancements.
• The market is segmented by product type, application, and region, with North America leading and Asia-Pacific and LAMEA offering growth opportunities.
• Regulatory reforms and competitive market dynamics are shaping the financial trajectory.
• Epoetin alfa is clinically effective but comes with safety considerations that need careful management.

Frequently Asked Questions

Q: What is the projected market size for erythropoietin drugs by 2034? A: The global erythropoietin drugs market is estimated to reach USD 14.3 billion by 2034[1].

Q: Which segment dominates the erythropoietin drugs market? A: The epoetin-alfa segment dominates the global market due to its high usage rate in alleviating anemia in patients with cancer and chronic renal failure[4].

Q: What are the key drivers of the erythropoietin drugs market? A: Key drivers include the increasing prevalence of chronic diseases, growing adoption of biosimilars, technological advancements, and expanding indications for erythropoietin drugs[1].

Q: What are the safety considerations associated with epoetin alfa? A: Safety considerations include increased cardiovascular risks, cancer-related risks, hypertension, and seizures, particularly in patients with chronic kidney disease[2].

Q: How does epoetin alfa impact the quality of life for patients with chronic kidney disease? A: Epoetin alfa significantly improves hemoglobin levels and quality of life in patients with chronic kidney disease, as indicated by improvements in the Karnofsky Performance Scale[2].

Cited Sources

1. GlobeNewswire: Erythropoietin Drugs Market Estimated to Reach USD 14.3 Billion, Advancing at a CAGR of 3.8% by 2034[1].
2. StatPearls: Epoetin Alfa | Treatment & Management[2].
3. Research and Markets: Erythropoietin (EPO) Global Market Report 2024[3].
4. Allied Market Research: Erythropoietin Drugs Market Size and Share Report, 2033[4].
5. PubMed: A systematic review and economic evaluation of epoetin alpha, epoetin beta and darbepoetin alpha[5].

Last updated: 2024-12-17