EPOGEN/PROCRIT Drug Profile

Summary for Tradename: EPOGEN/PROCRIT

High Confidence Patents:	5
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for EPOGEN/PROCRIT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EPOGEN/PROCRIT

Recent Clinical Trials for EPOGEN/PROCRIT

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sandoz	Phase 3

See all EPOGEN/PROCRIT clinical trials

Recent Litigation for EPOGEN/PROCRIT

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 EPOGEN/PROCRIT litigation

Pharmacology for EPOGEN/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. 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 EPOGEN/PROCRIT Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for EPOGEN/PROCRIT 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		2012-08-15	Company disclosures
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234		2013-08-20	Company disclosures
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234		2003-12-13	Company disclosures
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234		2015-05-26	Company disclosures
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234		2016-09-21	Company disclosures

3) Low Certainty: US Patents for EPOGEN/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.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234		2033-03-11	Patent claims search
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234		2039-02-26	Patent claims search
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234		2036-04-01	Patent claims search
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234		2027-08-21	Patent claims search
Amgen Inc.	EPOGEN/PROCRIT	epoetin alfa	Injection	103234		2039-02-26	Patent claims search

International Patents for EPOGEN/PROCRIT

Country	Patent Number	Estimated Expiration
Australia	5750490
Japan	H08269096
Japan	H0217156
Japan	2708099
South Korea	850004274

Supplementary Protection Certificates for EPOGEN/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
10199059	Germany		PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001-030 20010608
300075	Netherlands		PRODUCT NAME: DARBEPOETIN ALFA; REGISTRATION NO/DATE: EU/1/01/185/001 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 EPOGEN/PROCRIT

Introduction

EPOGEN (epoetin alfa) and PROCRIT, both developed by Amgen, are biologic drugs used to treat anemia associated with chronic kidney disease, chemotherapy, and other conditions. Here, we delve into the market dynamics and financial trajectory of these pivotal drugs.

Market Size and Growth

The global erythropoietin drugs market, which includes EPOGEN and PROCRIT, is projected to experience significant growth. By 2034, the market is estimated to reach $14.3 billion, growing at a CAGR of 3.8% from 2024 to 2034[1][4].

Key Segments

The erythropoietin drugs market can be segmented in several ways:

By Drug Class

• Epoetin Alfa: This is the class to which EPOGEN and PROCRIT belong.
• Epoetin Beta: Another form of erythropoietin.
• Darbepoetin Alfa: A longer-acting form of erythropoietin.
• Others: Other types of erythropoietin drugs[1].

By Drug Type

• Biologics: Original biologic drugs like EPOGEN and PROCRIT.
• Biosimilars: Generic versions of biologic drugs, such as Retacrit, which is a biosimilar of epoetin alfa[1][3].

By Drug Application

• Cancer: Used to treat anemia caused by chemotherapy.
• Renal Disease: Used for patients with chronic kidney disease.
• Hematology: Used for various blood disorders.
• Neurology: Used in some neurological conditions.
• Others: Other medical applications[1].

Market Competition and Biosimilars

The introduction of biosimilars has significantly impacted the market dynamics of EPOGEN and PROCRIT. For instance, Retacrit, a biosimilar of epoetin alfa, has surpassed the market share of the original drugs in some quarters, becoming the market leader in Q3 2023. This shift is due to competitive pricing and regulatory approvals that have streamlined the biosimilar market[3].

Financial Performance

Amgen's financial reports reflect the changing landscape of EPOGEN sales. In the fourth quarter of 2022, EPOGEN sales decreased by 11% year-over-year, primarily due to lower net selling prices. This decline is a result of increased competition from biosimilars and pricing pressures[2].

Revenue and Sales

• Total Product Sales: Despite the decline in EPOGEN sales, Amgen's total product sales remained robust, with $24.801 billion in 2022.
• Non-GAAP EPS: Amgen's non-GAAP EPS saw a 27% increase from 2021 to 2022, indicating overall financial health despite specific product declines[2].

Regional Market Dynamics

The erythropoietin drugs market varies significantly by region:

North America

• This region dominates the global market due to the presence of several approved and commercialized erythropoietin biosimilars.
• Companies like Amgen have a strong presence here, contributing to the market's growth[4].

Asia-Pacific and LAMEA

• These regions offer promising growth opportunities as they are less explored compared to North America and Europe.
• Local and multinational players are investing in research and development to address unmet medical needs in these areas[1][4].

Regulatory Environment

Ongoing regulatory reforms are crucial for the market's growth. Streamlining approval processes for biosimilars and biologics has fostered market competition, driven down costs, and enhanced accessibility to erythropoietin therapy globally[1].

Patient and Treatment Dynamics

The demand for erythropoietin drugs is driven by several factors:

Prevalence of Anemic Conditions

• The rise in prevalence of anemic conditions induced by end-stage renal disease treatment, chemotherapy, and antiretroviral treatment (ART) is a primary driver of the market[4].

Treatment Cycles and Incidences

• Increase in the number of treatment cycles for chemotherapy and the rising incidences of end-stage renal diseases have increased the demand for EPO[4].

Side Effects and Treatment Duration

• Despite the benefits, side effects such as arterial hypertension, iron deficiency, and influenza-like syndrome, along with the longer duration of EPO treatment (4-6 weeks), can restrain market growth[4].

Commercialization and Reimbursement

The commercialization of erythropoietin biosimilars and favorable reimbursement policies have boosted the market. Readily available reimbursements and favorable government regulations have increased the adoption of EPO therapeutics[4].

Key Takeaways

• The global erythropoietin drugs market is projected to reach $14.3 billion by 2034.
• Biosimilars, such as Retacrit, are gaining market share and driving competition.
• Regulatory reforms are enhancing market accessibility and reducing costs.
• The rise in anemic conditions and treatment cycles is driving demand.
• North America dominates the market, but Asia-Pacific and LAMEA offer significant growth opportunities.

FAQs

What is the projected market size of the erythropoietin drugs market by 2034?

The global erythropoietin drugs market is estimated to reach $14.3 billion by 2034, growing at a CAGR of 3.8% from 2024 to 2034[1].

How have biosimilars impacted the market for EPOGEN and PROCRIT?

Biosimilars like Retacrit have surpassed the market share of original drugs in some quarters, becoming market leaders due to competitive pricing and streamlined regulatory approvals[3].

What are the primary drivers of the erythropoietin drugs market?

The rise in prevalence of anemic conditions induced by end-stage renal disease treatment, chemotherapy, and antiretroviral treatment (ART) are primary drivers of the market[4].

Which regions offer the most promising growth opportunities for erythropoietin drugs?

Asia-Pacific and LAMEA regions offer promising growth opportunities as they are less explored compared to North America and Europe[1][4].

How have regulatory reforms affected the erythropoietin drugs market?

Regulatory reforms aimed at streamlining approval processes for biosimilars and biologics have fostered market competition, driven down costs, and enhanced accessibility to erythropoietin therapy globally[1].

Sources

1. GlobeNewswire: "Erythropoietin Drugs Market Estimated to Reach USD 14.3 billion, Advancing at a CAGR of 3.8% by 2034 - Transparency Market Research Inc."
2. Amgen: "AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2022 FINANCIAL RESULTS"
3. Samsung Bioepis: "Biosimilar Market Report - Q1 2024"
4. Allied Market Research: "Erythropoietin Drugs Market Size and Share Report, 2033"