ACCRETROPIN Drug Profile

Summary for Tradename: ACCRETROPIN

High Confidence Patents:	8
Applicants:	1
BLAs:	1

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 ACCRETROPIN Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ACCRETROPIN 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
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	8,206,948	2025-08-26	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	8,629,109	2031-07-05	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	8,822,410	2029-05-19	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	8,871,724	2029-02-20	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	8,912,143	2031-11-16	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	9,566,327	2033-02-08	DrugPatentWatch analysis and company disclosures
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	9,737,605	2034-03-11	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for ACCRETROPIN 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
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,016,338	2036-12-20	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,045,943	2036-04-08	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,154,856	2034-02-06	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,335,463	2037-11-28	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,364,451	2036-12-21	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,479,868	2035-09-04	Patent claims search
Emergent Biosolutions Canada Inc.	ACCRETROPIN	somatropin	Injection	021538	10,493,113	2038-11-14	Patent claims search

International Patents for ACCRETROPIN

Country	Patent Number	Estimated Expiration
Spain	2839549
Japan	2015512871
Japan	2018000205
Canada	2903769
Eurasian Patent Organization	015105
China	104844713
Japan	2016512523

Supplementary Protection Certificates for ACCRETROPIN

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
301172	Netherlands		PRODUCT NAME: LONAPEGSOMATROPINE; REGISTRATION NO/DATE: EU/1/21/1607 20220117
25/2022	Austria		PRODUCT NAME: LONAPEGSOMATROPIN; REGISTRATION NO/DATE: EU/1/21/1607 (MITTEILUNG) 20220117
2022C/513	Belgium		PRODUCT NAME: LONAPEGSOMATROPIN; AUTHORISATION NUMBER AND DATE: EU/1/21/1607 20220117
2290023-7	Sweden		PRODUCT NAME: LONAPEGSOMATROPIN; REG. NO/DATE: EU/1/21/1607 20220117
CR 2022 00020	Denmark		PRODUCT NAME: LONAPEGSOMATROPIN; REG. NO/DATE: EU/1/21/1607 20220117
PA2022506,C3653227	Lithuania		PRODUCT NAME: LONAPEGSOMATROPINAS; REGISTRATION NO/DATE: EU/1/21/1607 20220117
LUC00256	Luxembourg		PRODUCT NAME: LONAPEGSOMATROPINE; AUTHORISATION NUMBER AND DATE: EU/1/21/1607 20220117

Market Dynamics and Financial Trajectory for the Biologic Drug: ACCRETROPIN (Recombinant human erythropoietin)

Last updated: September 25, 2025

Introduction

ACCRETROPIN, a recombinant human erythropoietin (rhEPO), plays a pivotal role in managing anemia associated with chronic kidney disease (CKD), chemotherapy, and other conditions. As a biologic agent, it benefits from a specialized manufacturing process and regulatory landscape that influence its market dynamics and financial trajectory. This analysis delineates the key factors shaping ACCRETROPIN’s market position, growth prospects, and revenue drivers, providing stakeholders with a comprehensive understanding of its evolving landscape.

Market Overview and Therapeutic Landscape

The global erythropoietin market encompasses biologics targeting anemia management, particularly in CKD, cancer, and surgical recovery. The demand is driven by rising prevalence rates of CKD—estimated at over 850 million globally—and expanding oncology patient populations. As an original biologic, ACCRETROPIN competes against biosimilar erythropoietins, which have gained increasing acceptance owing to cost advantages.

Current therapeutic trends favor personalized treatment protocols with higher safety profiles, especially concerning risks of hypertension and thrombosis linked with erythropoietin therapy. The ongoing development of biosimilars and innovations in formulation techniques influences the clinical and commercial positioning of ACCRETROPIN. Regulatory frameworks, such as those in the U.S. and EU, impose stringent standards that reinforce the clinical confidence in genuine biologics like ACCRETROPIN, albeit with potential cost pressures from biosimilar entries.

Market Dynamics Influencing ACCRETROPIN

1. Market Penetration and Adoption Trends

ACCRETROPIN has historically maintained a strong foothold in the U.S. and European markets owing to regulatory approval and established manufacturing infrastructure. However, its market share faces downward pressure from biosimilar erythropoietins introduced by competitors, notably in cost-sensitive regions. The adoption rate hinges on prescriber confidence, reimbursement policies, and clinician familiarity with the product’s safety profile.

In emerging markets, where affordability dictates decision-making, ACCRETROPIN’s market penetration is limited unless supported by strategic partnerships or differential pricing. Manufacturers must navigate complex reimbursement landscapes and infrastructure limitations to expand access.

2. Pricing, Reimbursement, and Market Drivers

Pricing strategies directly impact ACCRETROPIN’s revenue trajectory. Original biologics traditionally command premium prices reflecting R&D investments and patent protections. Reimbursement policies, insurance coverage, and government formularies play critical roles; generous reimbursement in developed countries sustains higher margins, while price pressures in emerging markets necessitate adjustments.

Reimbursement trends increasingly favor biosimilars, exposing ACCRETROPIN to potential discounts and volume-based sales. Nonetheless, safety profiles and clinical efficacy remain key differentiators contributing to physician preference, especially for patients with complex comorbidities.

3. Competitive Landscape and Biosimilar Threats

The patent expiry of the original erythropoietin products has catalyzed biosimilar entry worldwide. These biosimilars, often priced 20–40% lower, threaten ACCRETROPIN’s market share, especially in price-sensitive segments. Yet, the quality, immunogenicity, and regulatory acceptance of biosimilars influence physician prescribing patterns.

Regulatory pathways in regions like the EU (via abbreviated biosimilar approval processes) have accelerated biosimilar commercialization, intensifying competition. ACCRETROPIN’s continued relevance depends on its established clinical profile, manufacturing excellence, and strategic alliances.

4. Regulatory and Patent Landscape

Regulatory considerations and patent protections directly affect ACCRETROPIN’s financial risk profile. Patent expirations in key markets necessitate diversification strategies, including line extensions, formulation innovations, or indications expansions, to prolong market exclusivity.

Emerging regulatory pathways for biosimilars also demand ongoing vigilance in compliance and quality standards, which may influence manufacturing costs and time-to-market for competitors.

Financial Trajectory and Revenue Forecasts

1. Revenue Generation and Growth Drivers

The revenue prospects for ACCRETROPIN hinge on:

• Market Share Maintenance: Continuing prescriber confidence and utilization in primary indications.
• Geographic Expansion: Penetration into emerging markets with evolving healthcare infrastructure.
• Clinical Adoption: Broadening indications, potentially encompassing anemia associated with other chronic conditions.
• Price Management: Balancing premium pricing in developed markets with affordability-driven strategies for emerging economies.

Forecasts suggest a moderate growth trajectory over the next 5–10 years, contingent on competitive pressures. In developed nations, revenue stability is likely maintained through extensive clinical data and reputation; in contrast, growth in emerging markets will depend on strategic collaborations and pricing.

2. Impact of Biosimilar Competition

Biosimilar erythropoietins have the potential to erode ACCRETROPIN’s revenue by 10–30% in regions with aggressive biosimilar uptake. However, the original biologic’s brand loyalty, proven safety, and efficacy could mitigate rapid erosion if supported by product differentiation and ongoing clinical evidence.

In regions where biosimilar penetration remains limited, ACCRETROPIN’s revenues may continue to grow modestly, especially if integrated into comprehensive anemia management protocols.

3. Cost and Investment Considerations

Maintaining regulatory compliance, investing in manufacturing optimization, and expanding clinical research entail significant costs that influence profitability margins. Moreover, lifecycle management strategies, including formulating next-generation formulations or fixed-dose combinations, require capital investment but offer potential revenue uplift.

Future Outlook and Market Opportunities

Innovations like subcutaneous delivery, extended dosing intervals, and combination therapies present opportunities to differentiate ACCRETROPIN. The integration of real-world evidence and personalized medicine approaches can enhance physician confidence, bolster market share, and justify premium pricing.

Additionally, expanding the therapeutic scope beyond CKD and oncology—such as indications for anemia associated with HIV or other chronic illnesses—could diversify revenue sources. Strategic collaborations, licensing agreements, and geographic expansion are critical leverage points for long-term financial growth.

Regulatory and Policy Trends

Global regulatory agencies are prioritizing biosimilar approvals and incentivizing cost-effective biologic therapies. Any regulatory hurdles or expedited pathways can accelerate or constrain market expansion. Policies favoring biosimilars, coupled with patent litigations and exclusivity rights, will significantly shape ACCRETROPIN’s financial longevity.

Key Takeaways

• The erythropoietin market is characterized by strong demand driven by CKD prevalence but faces intense biosimilar competition.
• ACCRETROPIN maintains a competitive advantage through clinical reputation, manufacturing quality, and established safety profiles.
• The revenue trajectory depends on regional market penetration, regulatory landscape, pricing strategies, and biosimilar dynamics.
• Strategic innovation and indication expansion are essential to sustain growth amid mounting competition.
• Collaboration, early adoption of technology, and navigating regulatory pathways are vital to maximizing long-term value.

FAQs

1. How does biosimilar erythropoietin affect ACCRETROPIN’s market share?
Biosimilars offer cost advantages, leading to increased uptake in price-sensitive markets, which can significantly diminish ACCRETROPIN’s market share, especially in regions where biosimilar approval is streamlined. However, ACCRETROPIN’s established safety profile can retain prescriber loyalty in certain indications.

2. What are the primary drivers of ACCRETROPIN’s revenue growth?
Key drivers include expanding geographic presence, increased adoption in existing markets, indication expansion, and differentiation through formulation innovations. Maintaining clinical confidence through robust data also supports ongoing demand.

3. Which regions present the most substantial growth opportunities for ACCRETROPIN?
Emerging markets in Asia, Latin America, and parts of Africa offer significant growth potential due to rising CKD prevalence and expanding healthcare infrastructure, provided the manufacturer adapts pricing and distribution strategies accordingly.

4. How do regulatory policies influence ACCRETROPIN’s financial outlook?
Regulatory pathways, patent protections, and approval processes determine market access timelines and exclusivity periods. Favorable policies expedite commercialization, while patent expirations necessitate strategic adjustments to sustain revenue.

5. What strategic moves can enhance ACCRETROPIN’s long-term competitiveness?
Investing in product lifecycle management, developing next-generation formulations, establishing strategic alliances, engaging in clinical research, and expanding into new indications are critical to securing sustained growth.

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References

[1] GlobalData Healthcare. Erythropoietin Market Analysis. 2022.
[2] IQVIA. The Impact of Biosimilar Entry on Biologic Revenues. 2021.
[3] World Health Organization. Global CKD Prevalence and Management. 2022.