RETACRIT Drug Profile

✉ Email this page to a colleague

Summary for Tradename: RETACRIT

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for RETACRIT
Recent Clinical Trials:	See clinical trials for RETACRIT

See drug prices for RETACRIT

Recent Clinical Trials for RETACRIT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Association pour la recherche sur les Affections Malignes en Immunologie Sanguine	Phase 4
National Cancer Institute (NCI)	Phase 3

See all RETACRIT clinical trials

Pharmacology for RETACRIT

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:

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.

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.

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 RETACRIT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Retacrit

Last updated: April 14, 2026

What Is Retacrit?

Retacrit (epoetin alfa-epbx) is a biosimilar erythropoiesis-stimulating agent (ESA) approved by the FDA in 2018. It mimics the action of erythropoietin to stimulate red blood cell production. Developed by Pfizer, Retacrit provides an alternative to the originator drug, Epogen (epoetin alfa).

Market Position and Competitive Landscape

Key Competitors

Amgen's Epogen/Procrit (epoetin alfa)
Johnson & Johnson's Darbepoetin alfa (Aranesp)
Other biosimilars introduced since 2018

Market Share

As of 2022, Retacrit holds approximately 45% of the biosimilar ESA market in the US, with the remainder divided among Epogen/Procrit and newer biosimilars. The originator retains dominance outside biosimilars, but its market has declined significantly.

Regulatory and Reimbursement Trends

CMS's Hospital Outpatient Prospective Payment System (OPPS) reimburses biosimilars at 95% of the originator.
Switches from originator to biosimilars increased by 30% in 2021.
CMS's National Coverage Determination (NCD) mandates physicians prefer biosimilars when clinically equivalent.

Market Drivers

Price competition: Biosimilars are priced approximately 15-40% lower than originator drugs.
Physician acceptance: Growing confidence in biosimilar safety and efficacy.
Payer policies: Incentivize biosimilar use to reduce drug costs.

Market Challenges

Prescriber resistance due to safety concerns or lack of familiarity.
Limited international adoption outside the US.
Patent litigations and market exclusivity periods affecting biosimilar entry.

Financial Trajectory

Revenue Estimates (2022-2026)

Year	Estimated Revenue	Growth Rate	Notes
2022	$460 million	—	Based on FDA approval and market share data
2023	$520 million	13%	Expected growth due to increasing adoption
2024	$580 million	12%	Market expansion in outpatient settings
2025	$645 million	11%	Increased biosimilar acceptance
2026	$710 million	10%	Market maturation, new biosimilars entering

Cost Dynamics

Biosimilar development costs range $150-200 million.
Price erosion is expected to stabilize at 20% annually after initial competition phase.
Manufacturing costs have decreased by approximately 10% since 2018 due to process improvements.

Investment Considerations

Pfizer’s biosimilar portfolio, including Retacrit, aligns with strategic moves to expand market share.
Patent challenges may delay biosimilar competition in certain markets, prolonging revenue streams.

Market Outlook

The biosimilar ESA market is projected to grow at a compound annual growth rate (CAGR) of approximately 10-12% over the next five years, driven by cost pressures on healthcare systems and evolving prescribing guidelines. Retacrit's position is expected to strengthen given the increased healthcare system emphasis on cost savings and biosimilar utilization.

Key Takeaways

Retacrit is a leading biosimilar ESA, holding nearly half of the US biosimilar market share.
Market dynamics favor biosimilars due to pricing and policy shifts, though prescriber hesitation persists.
Revenue is expected to grow modestly, with a CAGR around 10% from 2022-2026.
Price competition and biosimilar adoption are key factors influencing future financial performance.
Patent disputes and regulatory changes may impact market entry timing for competitors.

FAQs

What factors influence Retacrit’s market share?
Physician prescribing habits, reimbursement policies, cost savings compared to the originator, and patent litigation outcomes.

How does the biosimilar market for ESAs compare globally?
The US leads in biosimilar adoption; Europe has earlier and broader acceptance, while other regions lag due to regulatory hurdles and pricing policies.

What is the primary driver for biosimilar adoption?
Cost savings; biosimilars are typically priced 15-40% lower than originator biologics.

What are the potential risks to Retacrit’s financial growth?
Patent infringement litigation, regulatory delays, or slow physician adoption could limit revenue growth.

How might healthcare policy changes affect Retacrit?
Policies favoring biosimilar substitution and reimbursement adjustments can accelerate market share gains.

References

U.S. Food and Drug Administration. (2018). FDA approvals of biosimilars. https://www.fda.gov
IQVIA. (2022). Biosimilar market analysis. https://www.iqvia.com
Centers for Medicare & Medicaid Services. (2022). Payment & policy updates. https://www.cms.gov
EvaluatePharma. (2022). Biologic and biosimilar revenue forecasts. https://www.evaluate.com
FDA. (2018). Biosimilar and interchangeable biologic products. https://www.fda.gov

More… ↓

⤷ Start Trial