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	202799-002	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	202799-006	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	7,414,105
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-005	Mar 27, 2012	7,414,105
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-002	Mar 27, 2012	7,919,118
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-001	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
Australia	2004238868	Peptides that bind to the erythropoietin receptor
Japan	2007500218
Singapore	162747	ERYTHROPOIETIN RECEPTOR PEPTIDE FORMULATIONS AND USES
World Intellectual Property Organization (WIPO)	2009025958

Market Dynamics and Financial Trajectory for OMONTYS (Peginesatide) Injection

Introduction

OMONTYS (peginesatide) is an erythropoiesis-stimulating agent (ESA) developed for the treatment of anemia in patients with chronic kidney disease (CKD) on dialysis. Here, we will delve into the market dynamics and financial trajectory of OMONTYS since its approval.

Approval and Initial Market Impact

OMONTYS was approved by the U.S. Food and Drug Administration (FDA) on March 27, 2012. This approval was a significant milestone for Affymax, Inc., the biopharmaceutical company behind the drug, and its partner Takeda Pharmaceutical Company Limited[3].

Partnership and Commercialization

Affymax and Takeda entered into an exclusive global agreement in 2006 to develop and commercialize OMONTYS. Takeda holds the exclusive license to develop and commercialize the product outside the U.S., while both companies co-commercialize it within the U.S.[3].

Milestone Payments

The FDA approval triggered a $50 million milestone payment from Takeda to Affymax, in addition to a $5 million payment for the European Medicines Agency's acceptance of the Marketing Authorization Application earlier in 2012[3].

Market Positioning

OMONTYS was positioned as a treatment for symptomatic anemia associated with CKD in adult patients on dialysis. It was available in various strengths and formulations, including single-use, preservative-free injectable solutions and multiple-use vials with preservatives[1].

Safety and Efficacy Considerations

The drug's label highlighted several important safety considerations, including increased risks of mortality, myocardial infarction, stroke, and thromboembolism when targeting hemoglobin levels greater than 11 g/dL. This necessitated careful dose management to avoid rapid increases in hemoglobin levels[1].

Financial Performance

The financial performance of OMONTYS was closely tied to the partnership between Affymax and Takeda. While specific sales figures for OMONTYS alone are not readily available, the drug contributed to the overall revenue of both companies.

Affymax's Financials

Affymax's financial health was significantly impacted by the approval and commercialization of OMONTYS. The milestone payments from Takeda provided substantial revenue, but the company's long-term financial stability depended on the drug's market performance and ongoing development of other products.

Takeda's Financials

For Takeda, OMONTYS was part of a broader portfolio of pharmaceutical products. While it was an important addition, Takeda's financial performance was driven by a diverse range of products, including other ESAs and treatments for various conditions.

Market Challenges

OMONTYS faced several market challenges, including competition from other ESAs and stringent safety guidelines that limited its use. The drug was not indicated for patients with CKD who were not on dialysis, further restricting its market potential[1].

Regulatory Environment

The regulatory environment played a crucial role in the market dynamics of OMONTYS. The FDA's approval and subsequent warnings about the risks associated with ESAs affected how the drug was prescribed and used. Similar regulatory scrutiny in other regions, such as Europe, also influenced its global market trajectory[1].

Patient and Physician Adoption

The adoption of OMONTYS by patients and physicians was influenced by its efficacy, safety profile, and the availability of alternative treatments. The need for careful dose management and the potential for serious adverse events impacted its acceptance in clinical practice.

Competitive Landscape

The market for ESAs is competitive, with several other products available for the treatment of anemia in CKD patients. OMONTYS had to compete with established brands and newer entrants, each with their own safety and efficacy profiles.

Future Prospects

Despite its initial promise, OMONTYS faced significant challenges that impacted its long-term market prospects. The drug's future was further complicated by the evolving landscape of anemia treatments and the ongoing scrutiny of ESAs by regulatory bodies.

Key Takeaways

• Approval and Partnership: OMONTYS was approved by the FDA in 2012, with Affymax and Takeda partnering for its development and commercialization.
• Safety Considerations: The drug had significant safety warnings, including increased risks of mortality and cardiovascular events.
• Market Challenges: OMONTYS faced competition and regulatory challenges that limited its market potential.
• Financial Impact: The drug contributed to the financials of both Affymax and Takeda, though its long-term financial impact was limited by market and regulatory factors.

FAQs

What is OMONTYS used for?

OMONTYS (peginesatide) is used for the treatment of anemia in patients with chronic kidney disease (CKD) who are on dialysis.

Who developed and commercialized OMONTYS?

OMONTYS was developed by Affymax, Inc., and commercialized in partnership with Takeda Pharmaceutical Company Limited.

What are the significant safety concerns associated with OMONTYS?

OMONTYS is associated with increased risks of mortality, myocardial infarction, stroke, and thromboembolism, particularly when targeting hemoglobin levels greater than 11 g/dL.

Why was OMONTYS not indicated for patients with CKD not on dialysis?

OMONTYS was not indicated for patients with CKD who are not on dialysis due to safety concerns and lack of efficacy data in this population.

What was the financial impact of OMONTYS on Affymax and Takeda?

The approval and commercialization of OMONTYS generated significant milestone payments and contributed to the revenue of both companies, though its long-term financial impact was limited by market and regulatory challenges.

Sources

1. OMONTYS (peginesatide) Injection Label - FDA.
2. Sanofi Q2 2024 Financial Report - Sanofi.
3. Affymax Receives $50 Million Milestone Payment for U.S. Approval of OMONTYS - FierceBiotech.
4. OMONTYS (peginesatide injection) NDA - FDA.