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	202799-004	Mar 27, 2012		DISCN	No	No	7,550,433
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	7,919,461

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	202799-003	Mar 27, 2012	7,084,245
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-006	Mar 27, 2012	7,084,245
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-005	Mar 27, 2012	7,528,104

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)
China	101553242	Erythropoietin receptor peptide formulations and uses
Japan	2008542399

Market Dynamics and Financial Trajectory for Peginesatide Acetate

Introduction

Peginesatide acetate, marketed under the brand name OMONTYS, is a synthetic erythropoiesis-stimulating agent (ESA) designed to treat anemia in patients with chronic kidney disease (CKD) who are on dialysis. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its development, market performance, and the factors that led to its withdrawal.

Development and Approval

Peginesatide acetate was developed by Affymax and Takeda Pharmaceutical Company Limited. It was approved by the U.S. Food and Drug Administration (FDA) in March 2012 for the treatment of anemia in adult patients with CKD on dialysis[4].

Market Entry and Initial Reception

Upon its approval, OMONTYS was seen as a potential competitor to existing ESAs like epoetin alfa and darbepoetin alfa. The drug was praised for its once-monthly dosing regimen, which was more convenient than the more frequent dosing required by other ESAs. This convenience factor was expected to drive market adoption and patient compliance.

Financial Projections and Initial Performance

At the time of its launch, OMONTYS was projected to capture a significant share of the ESA market, given its unique dosing schedule and the large patient population with CKD. Affymax and Takeda anticipated strong revenue growth from the drug, which was part of their strategy to expand their presence in the global pharmaceutical market.

Safety Concerns and Regulatory Actions

However, the market trajectory of OMONTYS was drastically altered due to serious safety concerns. Shortly after its launch, reports of severe hypersensitivity reactions, including anaphylaxis, began to emerge. These reactions were life-threatening and required immediate medical attention[1][4].

Voluntary Withdrawal

On February 24, 2013, Affymax and Takeda voluntarily withdrew OMONTYS from the U.S. market due to these safety concerns. The decision was made in consultation with the FDA, highlighting the critical importance of patient safety over market potential[1].

Impact on Financials

The withdrawal of OMONTYS had a significant impact on the financials of both Affymax and Takeda. Affymax, in particular, faced substantial financial challenges following the withdrawal. The company's stock price plummeted, and it eventually filed for bankruptcy in 2013. Takeda, while larger and more diversified, also felt the financial sting of this withdrawal, though it was better positioned to absorb the loss[5].

Post-Withdrawal Market Dynamics

The withdrawal of OMONTYS left a gap in the ESA market, but it also underscored the importance of rigorous safety monitoring and post-marketing surveillance. Other ESAs, such as epoetin alfa and darbepoetin alfa, continued to dominate the market, with manufacturers emphasizing their safety profiles and long-term efficacy data.

Lessons Learned

The story of OMONTYS serves as a cautionary tale in the pharmaceutical industry. It highlights the delicate balance between innovation, market potential, and patient safety. Companies must invest heavily in safety studies and be prepared for the possibility of post-marketing adverse events that could impact the drug's market trajectory.

Financial Trajectory Summary

• Approval and Launch: Initial financial projections were positive, with expectations of significant revenue growth.
• Safety Concerns: Reports of severe allergic reactions led to a rapid decline in market confidence.
• Withdrawal: Voluntary withdrawal from the market resulted in substantial financial losses for Affymax and Takeda.
• Post-Withdrawal: The market gap was filled by other ESAs, and the incident emphasized the critical importance of safety in pharmaceutical development.

Key Takeaways

• Patient Safety: The primary concern in pharmaceutical development and marketing.
• Regulatory Compliance: Strict adherence to regulatory guidelines is crucial.
• Market Dynamics: Safety issues can rapidly alter market dynamics and financial trajectories.
• Financial Impact: The withdrawal of a drug can have devastating financial consequences for companies involved.

FAQs

What was the primary indication for peginesatide acetate?

Peginesatide acetate was indicated for the treatment of anemia in patients with chronic kidney disease (CKD) who are on dialysis.

Why was OMONTYS withdrawn from the market?

OMONTYS was withdrawn due to serious safety concerns, including severe hypersensitivity reactions such as anaphylaxis.

What were the financial implications of the withdrawal for Affymax and Takeda?

The withdrawal led to significant financial losses for both companies, with Affymax eventually filing for bankruptcy.

How did the withdrawal affect the ESA market?

The withdrawal left a gap in the ESA market, which was filled by other existing ESAs like epoetin alfa and darbepoetin alfa.

What lessons can be learned from the OMONTYS case?

The case highlights the importance of rigorous safety monitoring and the potential financial consequences of safety issues in pharmaceutical development.

Sources

1. Mayo Clinic: Peginesatide (injection route) - Mayo Clinic
2. Annual Reports: Amgen 2010 Annual Report and Financial Summary
3. ACS Nano: Polyethylene Glycol Immunogenicity: Theoretical, Clinical, and ...
4. FDA: OMONTYS (peginesatide) Injection Label
5. Regulations.gov: EXHIBIT 20 - Regulations.gov

Last updated: 2024-12-19