PROCRIT Drug Profile

Summary for Tradename: PROCRIT

High Confidence Patents:	5
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for PROCRIT

See drug prices for PROCRIT

Pharmacology for PROCRIT

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. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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 PROCRIT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for PROCRIT Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234		2007-10-23	DrugPatentWatch analysis and company disclosures
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234		2015-06-07	DrugPatentWatch analysis and company disclosures
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234		2015-06-06	DrugPatentWatch analysis and company disclosures
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234		2015-06-06	DrugPatentWatch analysis and company disclosures
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234		2013-08-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for PROCRIT 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.	PROCRIT	epoetin alfa	Injection	103234		2036-12-20	Patent claims search
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234		2034-03-14	Patent claims search
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234		2037-03-31	Patent claims search
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234		2036-11-15	Patent claims search
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234		2033-05-03	Patent claims search
Amgen Inc.	PROCRIT	epoetin alfa	Injection	103234		2034-03-13	Patent claims search

International Patents for PROCRIT

Country	Patent Number	Estimated Expiration
Israel	100935
Japan	H11253188
Canada	1339047
Czech Republic	443885
German Democratic Republic	255359
Japan	S61501627

Supplementary Protection Certificates for PROCRIT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
01C0050	France		PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001 20010608
300075	Netherlands		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 PROCRIT

Last updated: April 11, 2026

What is the Status of PROCRIT in the Market?

PROCRIT (epoetin alfa) is a recombinant human erythropoietin used to stimulate red blood cell production. Approved by the FDA in 1989, it primarily treats anemia caused by chronic kidney disease, chemotherapy, and certain surgeries. It is marketed by Johnson & Johnson’s subsidiary, Amgen, with biosimilars entering the market in recent years.

How Does the Market Size and Growth Provide Insight?

The global erythropoiesis-stimulating agent (ESA) market, dominated by PROCRIT and biosimilars, was valued at approximately $4.5 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of 5% through 2028, reaching around $7 billion.

The key drivers include:

• Growth in chronic kidney disease (CKD) populations.
• Adoption of biosimilars to reduce treatment costs.
• Increasing treatment rates in oncology-related anemia.

However, growth is tempered by safety concerns linked to ESA therapy, regulatory restrictions, and alternative treatments.

What Are the Regulatory and Competitive Dynamics?

PROCRIT's patent exclusivity ended with expiry of its primary patents around 2014, enabling biosimilar development. Biosimilars such as Epogen (Amgen), Retacrit (Pfizer), and others have entered the market, affecting revenue streams.

Regulatory pressure has increased. Agencies like the EMA and FDA impose restrictions on ESA use, especially targeting overuse and safety risks. The US FDA issued warnings in 2020 about targeting hemoglobin levels; such policies influence prescribing.

Sales declines for branded PROCRIT in key markets have occurred:

Year	Estimated US Sales (USD millions)	Change from Previous Year
2020	1,200	-10%
2021	1,080	-10%
2022	950	-12%

Biosimilar competition accounts for nearly 40% of the ESA market volume in North America as of 2022.

What Is the Financial Trajectory for PROCRIT?

Johnson & Johnson's Amgen reported a decline in ESA revenues:

• 2020: $1.2 billion
• 2021: $1.08 billion
• 2022: $950 million

Forecasts suggest continued decline at 8-10% annually over the next three years as biosimilar penetration increases. Some analytical estimates project:

Year	Projected US Sales (USD millions)	CAGR (2023-2026)
2023	~$870	-8.4%
2024	~$800	-8.4%
2025	~$735	-8.4%
2026	~$675	-8.2%

Global sales may contract further due to regulatory restrictions and shifts in clinical practice.

How Do Patent and Biosimilar Trends Impact Market Outlook?

Patent cliff led to generic biosimilar entry around 2014. The biosimilar market is expected to continue expanding, capturing an estimated 50% of ESA volume by 2025 (Market Research Future, 2021). The price differential of biosimilars, approximately 20-30% lower than branded versions, pressures gross margins of incumbents.

Johnson & Johnson & Amgen have responded with:

• Developing newer biosimilars with improved formulations.
• Diversifying into alternative anemia treatments (e.g., hypoxia-inducible factor stabilizers).
• Investing in clinical trials for new indications.

What Are the Future Market Drivers and Risks?

Key drivers:

• Rising CKD and cancer prevalence.
• Cost-saving initiatives favoring biosimilar adoption.
• Innovation in ESA delivery methods and formulations.

Risks include:

• Regulatory restrictions on ESA usage.
• Safety concerns over cardiovascular events linked to ESA therapy.
• Competition from new agents like HIF stabilizers (e.g., FibroGen, Akebia).

Summary of Market Dynamics & Financial Outlook

Aspect	Detail
Market Size	~$4.5 billion (2021), growing at 5% CAGR until 2028
Revenue Decline	2020: $1.2B; 2022: $950M; projected downtrend
Biosimilar Penetration	~40% market volume in 2022; rising
Patent Expiry	US patent expired circa 2014
Regulatory Environment	Increased restrictions; safety warnings
Future Trends	Biosimilar growth, new therapies, regulatory tightening

Key Takeaways

• PROCRIT faces declining revenues due to biosimilar competition and regulatory restrictions.
• The global ESA market is expected to grow modestly, but branded PROCRIT sales will contract further.
• Biosimilar adoption and pricing pressures will shape future profitability.
• Innovations in anemia management may offset some revenue losses.
• Companies investing in next-generation therapies or biosimilars will dominate the future landscape.

FAQs

Q1: How significant is biosimilar competition for PROCRIT?
Biosimilars account for roughly 40% of the ESA market volume in North America as of 2022, with further growth anticipated, exerting pricing and revenue pressure.

Q2: What regulatory factors impact PROCRIT sales?
FDA warnings on hemoglobin targets and restrictions on ESA use to mitigate cardiovascular risks limit prescribing, affecting sales volume and revenue.

Q3: Are there emerging alternatives to PROCRIT?
Yes. Hypoxia-inducible factor stabilizers are in late-stage clinical development, promising to replace or supplement existing ESAs.

Q4: How does the patent expiry affect PROCRIT’s market?
Patent expiry around 2014 opened the market to biosimilars, leading to increased competition and a decline in branded sales.

Q5: What are the primary growth opportunities?
Growth potential exists in Asia-Pacific markets due to increasing CKD prevalence, and through innovation in formulations and new therapeutic classes.

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References

[1] Market Research Future. (2021). Global Erythropoiesis-Stimulating Agent (ESA) Market Research Report.
[2] U.S. Food and Drug Administration. (2020). Warnings and Safety Precautions for ESA Therapy.
[3] Johnson & Johnson. (2022). Annual Reports and Financial Statements.
[4] Johnson & Johnson. (2022). Amgen Biosimilar Competitive Analysis.