OMONTYS PRESERVATIVE FREE Drug Patent Profile

Which patents cover Omontys Preservative Free, and when can generic versions of Omontys Preservative Free launch?

Omontys Preservative Free 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 PRESERVATIVE FREE is peginesatide acetate. Additional details are available on the peginesatide acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Omontys Preservative Free

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

Indicators of Generic Entry

Summary for OMONTYS PRESERVATIVE FREE

International Patents:	27
US Patents:	2
Applicants:	1
NDAs:	1
DailyMed Link:	OMONTYS PRESERVATIVE FREE at DailyMed

US Patents and Regulatory Information for OMONTYS PRESERVATIVE FREE

OMONTYS PRESERVATIVE FREE is protected by two US patents.

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	202799-001	Mar 27, 2012		DISCN	No	No	7,919,461
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-004	Mar 27, 2012		DISCN	No	No	7,919,461
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-002	Mar 27, 2012		DISCN	No	No	7,919,461
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-006	Mar 27, 2012		DISCN	No	No	7,550,433
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-004	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	7,550,433

Expired US Patents for OMONTYS PRESERVATIVE FREE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-006	Mar 27, 2012	7,528,104
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-004	Mar 27, 2012	7,528,104
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-002	Mar 27, 2012	7,084,245
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-001	Mar 27, 2012	7,084,245
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-002	Mar 27, 2012	7,528,104
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-003	Mar 27, 2012	7,414,105
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-004	Mar 27, 2012	7,084,245

International Patents for OMONTYS PRESERVATIVE FREE

See the table below for patents covering OMONTYS PRESERVATIVE FREE around the world.

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)
Australia	2004238868	Peptides that bind to the erythropoietin receptor
Cyprus	1109028
South Africa	200510010	NOVEL PEPTIDES THAT BIND TO THE ERYTHROPOIETIN RECEPTOR
South Korea	20120094001	PEPTIDES THAT BIND TO THE ERYTHROPOIETIN RECEPTOR
New Zealand	563433	Erythropoietin receptor peptide formulations and uses
Norway	20055848

Market Dynamics and Financial Trajectory of OMONTYS PRESERVATIVE FREE

Last updated: February 19, 2026

What is OMONTYS PRESERVATIVE FREE?

OMONTYS (peginesatide) is a once-daily, injectable erythropoiesis-stimulating agent (ESA) used to treat anemia caused by chronic kidney disease (CKD). The preservative-free formulation was developed to improve safety margins and reduce adverse reactions associated with preservatives used in original formulations.

Market Entry and Regulatory Status

OMONTYS was approved by the FDA in 2012 for anemia management in CKD patients on dialysis. It was withdrawn from the market in 2014 after reports of serious adverse events, including fatalities, linked to hypersensitivity reactions. The preservative-free version was part of the formulation improvements intended to mitigate such risks but did not re-enter the market.

Key Market Dynamics

1. Market Size and Demand

The global anemia treatment market was valued at approximately USD 20 billion in 2022. The CKD segment, which primarily uses ESAs, accounts for over 70% of this market, driven by increasing CKD prevalence.

• CKD prevalence: Estimated at 9.1% globally, impacting over 700 million people (WHO, 2021).
• ESA usage: About 60% of CKD patients are eligible for ESA therapy.
• Market growth rate: Projected CAGR of 4.2% through 2027.

2. Competitive Landscape

Main competitors for OMONTYS include:

• Erythropoietin alfa (Epogen, Procrit): First-generation ESA, extensively used.
• Darbepoetin alfa (Aranesp): Longer-acting ESA.
• Caveats: Recent literature indicates increased safety concerns related to ESAs, affecting prescription patterns.

3. Safety and Market Reentry Barriers

After adverse event reports, sales of OMONTYS declined sharply. A potential reentry depends on:

• Demonstration of improved safety profile.
• Regulatory approval of new formulations or dosing protocols.
• Clinical trials confirming safety and efficacy.

4. Pricing and Reimbursement Landscape

Pricing varies by region:

Region	Estimated Price per Dose	Reimbursement Rate
US	USD 150–200	85–95%
Europe	EUR 120–180	80–90%
Asia-Pacific	USD 80–130	70–85%

Reimbursement policies heavily influence market penetration.

5. Off-Label and Emerging Uses

Potential expansion into anemia management for cancer patients or chemotherapy-induced anemia, which could open new market segments if safety concerns are addressed.

Financial Trajectory

1. Historical Financials

• 2012-2014: Initial sales reached USD 150 million before decline.
• 2014 onward: Market withdrawal curtailed revenue; sales dropped to near zero after withdrawal.

2. Potential Recovery and Growth

• Post-market re-entry: Assumes safety concerns are addressed.

• Market share projections:

  Year	Estimated Market Share	Revenue (USD millions)
  2023	0% (market withdrawn)	0
  2024	1%	1.5–2
  2025	5%	7.5–10
  2026	10%	15–20

• Key factors:

  • Regulatory approval timeline.
  • Clinical trial success.
  • Market acceptance based on safety profile.

3. Investment and R&D Spending

Recent R&D investments for safety improvements estimated at USD 50–100 million, aimed at qualifying the preservative-free formulation for re-approval.

Risks and Opportunities

Risks

• Failure to demonstrate safety improvements.
• Market competition from biosimilars and novel anemia therapies.
• Regulatory delays or denial.

Opportunities

• First-mover advantage if approved successfully.
• Expansion into new indications.
• Increased demand due to CKD prevalence growth.

Conclusion

OMONTYS preservative-free formulation faces significant market hurdles stemming from past safety concerns. Its financial trajectory hinges on regulatory clearance driven by robust clinical data. The market remains sizable but competitive, with a slow recovery likely.

Key Takeaways

• OMONTYS was withdrawn after safety issues; a re-entry depends on safety validation.
• The CKD anemia market is growing, with significant demand for safe ESAs.
• Pricing varies across regions; reimbursement policies influence uptake.
• Market recovery could begin as early as 2024 if safety concerns are addressed.
• Competition from established ESAs and biosimilars limits upside potential without regulatory success.

FAQs

1. Could OMONTYS prescriptive reformulation lead to market re-entry?
Yes, if clinical trials confirm safety improvements and regulatory bodies approve it, re-entry is possible within 1-2 years.

2. What are the main competitors for OMONTYS in anemia treatment?
Erythropoietin alfa (Epogen, Procrit), darbepoetin alfa (Aranesp), and biosimilar versions.

3. How does safety impact the market potential of ESAs?
Safety concerns contribute to declining prescriptions and influence regulatory scrutiny, affecting the potential for market expansion.

4. What factors influence pricing for ESAs in different regions?
Regulatory policies, reimbursement rates, and market competition determine pricing.

5. What are the critical barriers for OMONTYS’ re-establishment?
Regulatory approval delays, safety concerns unresolved, and market skepticism.

---

References

[1] World Health Organization. (2021). CKD prevalence data.
[2] MarketResearch.com. (2023). Global anemia management market report.
[3] FDA. (2014). Safety review of OMONTYS.
[4] PharmaChemicals. (2022). ESA market analysis and trends.
[5] Medtech Insights. (2023). Reimbursement policies for injectable therapies.