OMONTYS Drug Patent Profile

When do Omontys patents expire, and when can generic versions of Omontys launch?

Omontys is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-seven patent family members in eighteen countries.

The generic ingredient in OMONTYS is peginesatide acetate. Additional details are available on the peginesatide acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Omontys

Omontys was eligible for patent challenges on March 27, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 2, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OMONTYS

International Patents:	27
US Patents:	2
Applicants:	1
NDAs:	1
Clinical Trials:	18
DailyMed Link:	OMONTYS at DailyMed

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

NDA:

202799

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.

Recent Clinical Trials for OMONTYS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Amgen	Phase 4
Takeda	Phase 3
Affymax	Phase 3

See all OMONTYS clinical trials

US Patents and Regulatory Information for OMONTYS

OMONTYS is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-007	Mar 27, 2012		DISCN	No	No
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-002	Mar 27, 2012		DISCN	No	No
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-008	Mar 27, 2012		DISCN	No	No
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-004	Mar 27, 2012		DISCN	No	No
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-002	Mar 27, 2012		DISCN	No	No
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-006	Mar 27, 2012		DISCN	No	No

Expired US Patents for OMONTYS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-008	Mar 27, 2012
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-007	Mar 27, 2012
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-008	Mar 27, 2012
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-007	Mar 27, 2012
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-008	Mar 27, 2012
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-008	Mar 27, 2012

International Patents for OMONTYS

When does loss-of-exclusivity occur for OMONTYS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering OMONTYS around the world.

Country	Patent Number	Title	Estimated Expiration
Cyprus	1109028
South Korea	101160611
European Patent Office	1629007	NOUVEAUX PEPTIDES SE FIXANT AU RECEPTEUR DE L'ERYTHROPOIETINE (NOVEL PEPTIDES THAT BIND TO THE ERYTHROPOIETIN RECEPTOR)
China	1849141	Spacer moiety for poly(ethylene glycol)-modified peptide- based compounds
Japan	2008542399
South Africa	200509970	Novel spacer moiety for poly (ethylene glycol) modified peptide based compounds

Market Dynamics and Financial Trajectory for OMONTYS (Peginesatide)

Last updated: July 28, 2025

Introduction

OMONTYS (peginesatide), developed by Affymax and established as a synthetic erythropoiesis-stimulating agent (ESA), targeted the treatment of anemia in chronic kidney disease (CKD) patients. Approved by the U.S. Food and Drug Administration (FDA) in 2012, OMONTYS introduced a novel subcutaneous dosing paradigm aimed at improving patient compliance and reducing treatment complexity. However, its subsequent market withdrawal in 2013 underscores the volatile landscape of pharmaceutical innovation, regulatory scrutiny, and commercial viability. This analysis examines the recent market dynamics and financial trajectory of OMONTYS, emphasizing factors that shaped its rise and decline, and projects future implications for stakeholders.

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Market Context and Initial Launch Dynamics

Targeted Market and Clinical Need

Chronic kidney disease-associated anemia affects approximately 37 million Americans, with widespread unmet needs for effective, safe, and convenient therapies [1]. Prior to OMONTYS, drugs like epoetin alfa and darbepoetin alfa dominated the market, but faced challenges such as frequent dosing and adverse safety signals, especially cardiovascular risks associated with high-dose ESAs. OMONTYS was designed to address these issues by offering a once-monthly dosing schedule and a synthetic, chemically stable formulation, which promised improved patient adherence and ease of administration.

Regulatory Pathway and Approval

OMONTYS completed Phase 3 clinical trials demonstrating non-inferiority to existing ESAs and was granted FDA approval in June 2012. The pivotal trials reported favorable efficacy and safety profiles, capturing investor optimism. The approval marked a significant milestone for Affymax, positioning OMONTYS as a potential competitor capable of capturing market share due to its simplified dosing and manufacturing process.

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Market Dynamics Post-Launch

Initial Market Reception and Adoption

In the immediate aftermath of approval, OMONTYS gained limited commercial penetration, hindered by logistical challenges and skepticism inherent in introducing a new ESA. Market adoption was slow, compounded by existing contracts and formulary preferences favoring established drugs like Epogen and Aranesp. Moreover, the healthcare landscape was increasingly scrutinizing ESAs' safety profiles, particularly following reports linking high doses to adverse cardiovascular events [2].

Safety Concerns and Market Withdrawal

In late 2012, shortly after commercialization, safety signals emerged. Post-marketing data indicated an increased incidence of hypersensitivity reactions and potential cardiovascular risks, prompting the FDA to issue a boxed warning and recommend a comprehensive risk evaluation. The safety concerns, coupled with limited sales momentum amid physician reticence, led Affymax to suspend distribution by April 2013. A voluntary product recall followed, marking a premature end to OMONTYS’s commercial endeavors.

Competitive and Regulatory Pressures

The OMONTYS case exemplifies the impact of post-market safety surveillance and regulatory vigilance, especially for biologics and biosimilars. Given the dominance of established ESAs, regulatory scrutiny, and safety risks, new entrants must demonstrate superior safety profiles and clear clinical advantages. The subsequent shift towards gold-standard therapies, combined with evolving guidelines advocating cautious ESA use, further marginalized OMONTYS.

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Financial Trajectory and Investor Implications

Pre-Launch Valuation and Funding

Affymax, a biotech firm with limited prior commercial experience, raised approximately $130 million through an initial public offering (IPO) in 2011, partly based on the promising data for OMONTYS [3]. The company’s valuation reflected high expectations for market capture and revenue generation.

Revenue Projections and Market Realities

Initial estimates projected peak US sales for OMONTYS reaching approximately $300-$400 million annually. However, these projections did not materialize due to delayed market entry, safety concerns, and competition from well-established therapies. Limited uptake resulted in negligible revenue, with AFFYMAX reporting minimal sales figures even before market withdrawal.

Market Withdrawal and Financial Fallout

Following the safety concerns disclosures in late 2012, the company faced declining investor confidence. The suspension of sales led to significant write-downs, impairment charges, and eventual insolvency in 2013. Investors incurred substantial losses, illustrating the risks inherent in late-stage biotech commercialization without robust safety data.

Ongoing Financial Implications

The OMONTYS case underscores the importance of post-approval safety monitoring and real-world evidence collection. Future biotech investments in similar biologics necessitate comprehensive risk management strategies and phased commercialization plans. Adoption failures can result in steep financial reversals, emphasizing prudence in market entry timing and safety communications.

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Broader Market and Industry Trends

Shift Towards Biosimilars and Alternative Therapies

The discontinuation of OMONTYS correlates with broader trends favoring biosimilars and newer therapeutic modalities. The biosimilar landscape, especially for ESAs, is expanding, offering cost-effective alternatives and heightened regulatory standards. Companies must navigate complex manufacturing, regulatory, and safety landscapes to succeed in this environment.

Regulatory Evolution and Patient Safety

Post-market surveillance has become integral in biologic drug approval and commercialization. The OMONTYS experience illustrates how safety concerns can rapidly shift market dynamics, reinforce the importance of robust clinical safety data, and influence clinical prescribing behaviors.

Innovation Strategies and Risk Mitigation

Biopharma firms are increasingly adopting adaptive development, real-world evidence integration, and strategic collaborations to mitigate risks associated with novel biologics. The emphasis on safety and efficacy data collection before commercialization is paramount.

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Future Outlook

While OMONTYS is no longer active in the market, its case imparts critical lessons. Future similar biologics will need carefully crafted development programs that prioritize safety, demonstrate clear clinical advantages, and align with evolving regulatory rigor. Companies contemplating market entry should invest heavily in post-market safety evaluations, physician education, and transparent communication to mitigate risks of safety signals that can derail commercial success.

For investors and stakeholders, understanding the complexities of biosimilar development, regulatory standards, and safety profile management is essential. The trajectory of OMONTYS exemplifies how strategic missteps or unforeseen safety concerns can rapidly terminate market ambitions, leading to financial losses and diminished reputation.

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Key Takeaways

• Regulatory Vigilance is Paramount: Post-market safety concerns can swiftly alter a drug’s commercial fate, underscoring the importance of comprehensive safety data prior to and during launch.

• Market Penetration Challenges Remain Significant: Even innovative formulations like OMONTYS face hurdles such as physician acceptance, formulary restrictions, and entrenched competitors.

• Safety Signals Can Derail Revenue: Early safety issues, especially with biologics, can lead to rapid market withdrawal and financial losses, highlighting risks of late-stage development and commercialization.

• Invest in Real-World Evidence: Continuous safety monitoring and real-world data collection are pivotal in sustaining drug viability and guiding clinical use.

• Strategic Planning is Critical: Successful market entry necessitates a thorough understanding of regulatory landscapes, competitor environment, and safety profiles to avoid costly failures.

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FAQs

1. What led to the market withdrawal of OMONTYS?
   The withdrawal was driven by safety concerns, including hypersensitivity reactions and cardiovascular risks identified post-approval, which prompted regulatory warnings and voluntary recall by the manufacturer.

2. Did OMONTYS offer any clinical advantages over existing ESAs?
   While OMONTYS was designed to offer once-monthly dosing and synthetic stability, safety issues limited its clinical adoption and negated potential advantages.

3. What lessons can other biotech companies learn from OMONTYS?
   Prioritize extensive safety data collection, proactive post-market monitoring, and strategic communication to prevent safety signals from undermining market potential.

4. Could OMONTYS have succeeded if safety concerns were mitigated earlier?
   Potentially, yes. Early identification and management of safety issues, combined with targeted physician education and regulatory engagement, might have improved market outcomes.

5. What is the current landscape for ESAs targeting CKD anemia?
   The landscape is dominated by biosimilars and existing agents, with increased regulatory scrutiny emphasizing safety. New entrants must demonstrate superior safety profiles and cost-effectiveness to capture market share.

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References

[1] U.S. Renal Data System. (2022). USRDS 2022 Annual Data Report. National Institutes of Health.

[2] Singh, A. K., et al. (2010). "Cardiovascular risks of ESA therapy in CKD." New England Journal of Medicine, 363(24), 2299–2311.

[3] Affymax. (2011). IPO Prospectus. Securities and Exchange Commission filings.

Note: Data and references are illustrative; for in-depth research, consult current sources and regulatory databases.