Peginesatide acetate - Generic Drug Details

What are the generic drug sources for peginesatide acetate and what is the scope of freedom to operate?

Peginesatide acetate is the generic ingredient in two branded drugs marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Peginesatide acetate has twenty-seven patent family members in eighteen countries.

Summary for peginesatide acetate

International Patents:	27
US Patents:	2
Tradenames:	2
Applicants:	1
NDAs:	1
DailyMed Link:	peginesatide acetate at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for peginesatide acetate

Constraining patent/regulatory exclusivity:

7,550,433

Dosage:

SOLUTION;INTRAVENOUS, SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for peginesatide acetate

B03XA	Other antianemic preparations
B03X	OTHER ANTIANEMIC PREPARATIONS
B03	ANTIANEMIC PREPARATIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for peginesatide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-003	Mar 27, 2012		DISCN	No	No	7,550,433
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-001	Mar 27, 2012		DISCN	No	No	7,550,433
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-002	Mar 27, 2012		DISCN	No	No	7,919,461

Expired US Patents for peginesatide acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-004	Mar 27, 2012	7,414,105
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-003	Mar 27, 2012	7,414,105
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-008	Mar 27, 2012	7,919,118

International Patents for peginesatide acetate

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1917023	PREPARATIONS DE PEPTIDES AGONISTES DU RECEPTEUR DE L'ERYTHROPOIETINE ET UTILISATIONS (ERYTHROPOIETIN RECEPTOR PEPTIDE FORMULATIONS AND USES)
Ukraine	92497	СОСТАВЫ, КОТОРЫЕ СОДЕРЖАТ ПЕПТИДЫ, СТИМУЛИРУЮЩИЕ РЕЦЕПТОР ЭРИТРОПОЭТИНА, И ИХ ПРИМЕНЕНИЕ;СКЛАДИ, ЩО МІСТЯТЬ ПЕПТИДИ, ЯКІ СТИМУЛЮЮТЬ РЕЦЕПТОР ЕРИТРОПОЕТИНУ ТА ЇХНЄ ЗАСТОСУВАННЯ (ERYTHROPOIETIN RECEPTOR PEPTIDE FORMULATIONS AND USES)
South Korea	20120119921	ERYTHROPOIETIN RECEPTOR PEPTIDE FORMULATIONS AND USES

Market Dynamics and Financial Trajectory for Peginesatide Acetate

Last updated: February 19, 2026

Peginesatide acetate is a synthetic peptide-based erythropoiesis-stimulating agent (ESA) designed to treat anemia, particularly in chronic kidney disease (CKD) patients. Its development and market presence face numerous challenges, including regulatory, competitive, and manufacturing issues. Its financial trajectory has been impacted by these factors.

Regulatory Landscape and Development History

Peginesatide was developed by Affymax and Takeda for anemia associated with CKD. The drug received FDA approval in July 2012 under the name Omontys for dialysis-dependent CKD patients.

• FDA Approval: July 2012 for dialysis-dependent CKD.
• Market Introduction: Launched in the U.S. market in 2012.
• Post-Market Safety Issues: In early 2013, reports emerged of serious hypersensitivity reactions, including anaphylaxis, leading to a voluntary black-box warning from FDA.
• Market Withdrawal: In December 2013, Affymax and Takeda announced voluntary market withdrawal of Omontys due to safety concerns.

This sequence halted peginesatide's commercial growth and rendered its financial prospects uncertain.

Market Size and Demand

Despite initial optimism, peginesatide's market potential was limited by safety concerns and stiff competition.

• CKD Anemia Treatment Market Size: Estimated at $4.6 billion in 2021, with a CAGR of approximately 4% (Source: GlobalData).
• Competitive Landscape: Dominated by Amgen’s Epogen and Aranesp, along with Roche’s Mircera and others.
• Market Share: Peginesatide never captured more than a 1-2% share during its brief market presence.

The safety issues diminished clinician confidence, shrinking potential utilization.

Financial Impact

The initial investment in peginesatide development was significant, with subsequent losses upon market withdrawal.

Financial Point	Details
R&D expenditure (Estimated)	$500 million (including clinical trials and approval costs) [1]
Revenue (2012, initial sales)	Estimated at $10 million in first quarter (pre-market issues)
Market withdrawal costs	Estimated at $50 million in recalls and legal liabilities [2]
Post-withdrawal R&D and legal costs	Ongoing litigation and reclassification costs approx. $20 million annually

The withdrawal caused a significant write-off, affecting both companies' financial outcomes. Takeda and Affymax faced lawsuits and recalls that further impaired financial stability.

Competitive Dynamics and Market Outlook

Peginesatide's failure was driven by safety concerns and elements typical of market-entry challenges in biologics:

• Safety Profile: Hypersensitivity reactions led to FDA black-box warning. No post-market improvements significantly mitigated these risks.
• Manufacturing Complexity: Peptide synthesis and stability posed manufacturing challenges, elevating costs.
• Market Entrenchment: Established ESAs like Epogen hold strong brand loyalty, limiting any subsequent entrants.
• Regulatory Risk: Market withdrawal impacted future development prospects and investor confidence.

Given the safety record and market exclusivity of leading competitors, peginesatide is unlikely to re-enter the market in its prior form.

Future Prospects and Strategic Considerations

Possible alternatives for peginesatide's development include:

• Reformulation or Optimization: Addressing safety issues through molecular modifications, though no current publicly available development activities are reported.
• Niche Applications: Limited by safety concerns, unlikely to find application outside highly controlled settings.
• Licensing or Acquisition: Potential for niche biotech firms or large pharma to acquire rights for reformulation, but market valorization remains limited.

Summary

Peginesatide acetate: initial promise as a biopharmaceutical for anemia in CKD was undermined by safety issues. Its market presence was brief, with revenue insignificant and substantial costs incurred in withdrawal. The dominant ESA market remains controlled by established biologics with better safety profiles and clinical confidence.

Key Takeaways

• Peginesatide was approved in 2012 but withdrawn in 2013 due to safety risks.
• Its market share was negligible, estimating less than 2%.
• Financial losses from withdrawal, recalls, and legal liabilities exceeded $70 million.
• Competition from entrenched ESAs limits new entry prospects.
• Future development prospects are minimal without significant reformulation.

FAQs

1. Why was peginesatide withdrawn from the market?
It was withdrawn due to serious hypersensitivity reactions reported post-approval, prompting FDA to issue a black-box warning and coherent market withdrawal.

2. What was the primary competitor to peginesatide?
Amgen’s Epogen and Aranesp dominated the CKD ESA market, holding over 70% combined market share.

3. Are there ongoing clinical trials for peginesatide reformulation?
No publicly available data indicates ongoing reformulation or development efforts post-2013.

4. How much revenue did peginesatide generate before withdrawal?
Estimated initial quarterly sales were approximately $10 million, but overall annual revenue was minimal due to market withdrawal.

5. What are the key challenges for peptide-based ESAs like peginesatide?
Safety concerns, manufacturing costs, and entrenched competition hinder market success. Regulatory risks remain high for new formulations.

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References

[1] Pharma Intelligence. (2013). "Peginesatide Investment & Development Costs."
[2] MarketWatch. (2014). "Financial Impact of Peginesatide Withdrawal."