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
Affymax	Phase 3
Takeda	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
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-005	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	202799-007	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
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-007	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:

Australia

Brazil

Canada

China

Costa Rica

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Japan

Mexico

Morocco

New Zealand

Norway

Singapore

South Africa

South Korea

Ukraine

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
Mexico	PA05012316	PEPTIDOS NOVEDOSOS QUE SE UNEN AL RECEPTOR DE LA ERITROPOYETINA. (NOVEL PEPTIDES THAT BIND TO THE ERYTHROPOIETIN RECEPTOR.)
South Korea	20120119921	ERYTHROPOIETIN RECEPTOR PEPTIDE FORMULATIONS AND USES
Singapore	160224	NOVEL PEPTIDES THAT BIND TO THE ERYTHROPOIETIN RECEPTOR
Israel	171782	PEPTIDE DIMERS WHICH COMPRISE POLYETHYLENE GLYCOL THAT BIND TO THE ERYTHROPOIETIN RECEPTOR, PHARMACEUTICAL COMPOSITIONS THEREOF AND USE THEREOF
South Africa	200711020	Erythropoietin receptor peptide formulations and uses
Canada	2525568	NOUVEAUX PEPTIDES SE FIXANT AU RECEPTEUR DE L'ERYTHROPOIETINE (NOVEL PEPTIDES THAT BIND TO THE ERYTHROPOIETIN RECEPTOR)

Market Dynamics and Financial Trajectory for Omontys (Peginesatide)

Introduction

Omontys (peginesatide) is an erythropoiesis-stimulating agent (ESA) developed by Affymax and Takeda Pharmaceutical Company for the treatment of anemia associated with chronic kidney disease (CKD). Here, we delve into the market dynamics and financial trajectory of this drug.

Development and Approval

Omontys was approved by the FDA on March 27, 2012, following the submission of a New Drug Application (NDA) in May 2011. The approval was based on the results from two Phase III clinical studies, EMERALD 1 and EMERALD 2, which compared Omontys with epoetin alfa in dialysis patients[1].

Clinical Trials and Efficacy

The clinical trials for Omontys included four Phase III studies: EMERALD 1, EMERALD 2, PEARL 1, and PEARL 2. These studies involved over 2,600 patients across 400 centers in the US and Europe. The trials demonstrated the efficacy of Omontys in maintaining hemoglobin (Hb) levels in patients with CKD[1].

Market Launch and Initial Reception

Following FDA approval, Omontys was launched in the US in April 2012 by Takeda and Affymax. It was the first once-monthly ESA for the treatment of anemia associated with CKD, offering a more convenient dosing schedule compared to existing treatments[1].

Financial Milestones

Affymax received significant financial milestones for the development and approval of Omontys. A $50 million milestone payment was received from Takeda upon FDA approval, in addition to a $5 million payment triggered by the European Medicines Agency's acceptance of the Marketing Authorization Application[5].

Revenue and Financial Performance

In the second quarter of 2012, Affymax reported total revenue of $2.8 million, a significant decrease from $14.2 million in the same period of 2011. This decline was due to lower collaboration revenue from Takeda, as the research and development expenses reimbursable by Takeda had decreased following the completion of the NDA filing for Omontys[2].

Marketing and Distribution

Takeda was responsible for marketing Omontys in the US and the European Union. The partnership between Affymax and Takeda included provisions for Takeda to purchase active pharmaceutical ingredients and reimburse development expenses, which were recognized under the Contingency Adjusted Performance Model (CAPM) of revenue recognition[2].

Challenges and Recall

Despite the initial success, Omontys faced significant challenges. In February 2013, Affymax and Takeda announced a nationwide voluntary recall of all lots of Omontys due to postmarketing reports of serious hypersensitivity reactions, including anaphylaxis, which could be life-threatening or fatal. This recall led to a halt in new or existing patient treatments with Omontys[4].

Impact on Financials

The recall had a devastating impact on Affymax's financials. The company's stock plummeted, and it faced significant financial difficulties. The recall also led to a reevaluation of the drug's market potential and the partnership between Affymax and Takeda.

Conclusion

Omontys represented a promising innovation in the treatment of anemia associated with CKD, offering a once-monthly dosing regimen. However, the drug's market trajectory was marred by serious safety concerns leading to a voluntary recall. This event highlighted the risks and challenges associated with bringing new pharmaceuticals to market.

Key Takeaways

• Approval and Launch: Omontys was approved by the FDA in March 2012 and launched in the US in April 2012.
• Clinical Efficacy: The drug demonstrated efficacy in maintaining Hb levels in CKD patients through several Phase III trials.
• Financial Milestones: Affymax received significant milestone payments from Takeda upon FDA approval and EMA acceptance.
• Challenges and Recall: The drug was recalled in February 2013 due to serious hypersensitivity reactions.
• Financial Impact: The recall severely impacted Affymax's financial performance and market outlook.

FAQs

Q: What is Omontys (peginesatide), and what is it used for? A: Omontys is an erythropoiesis-stimulating agent (ESA) used for the treatment of anemia associated with chronic kidney disease (CKD).

Q: When was Omontys approved by the FDA? A: Omontys was approved by the FDA on March 27, 2012.

Q: What were the key clinical trials for Omontys? A: The key clinical trials included EMERALD 1, EMERALD 2, PEARL 1, and PEARL 2, involving over 2,600 patients.

Q: Why was Omontys recalled from the market? A: Omontys was recalled due to postmarketing reports of serious hypersensitivity reactions, including anaphylaxis.

Q: How did the recall impact Affymax financially? A: The recall led to a significant decline in Affymax's stock value and posed substantial financial difficulties for the company.

Sources

1. Clinical Trials Arena: Omontys (peginesatide) – for Treatment of Anaemia Associated with Chronic Kidney Disease[1].
2. Business Wire: Affymax Reports Second Quarter 2012 Financial Results[2].
3. Annual Reports: Amgen 2010 Annual Report and Financial Summary[3].
4. Takeda: Affymax and Takeda Announce a Nationwide Voluntary Recall of All Lots of OMONTYS® (peginesatide) Injection[4].
5. Fierce Biotech: Affymax Receives a $50 Million Milestone Payment for U.S. Approval of OMONTYS® (peginesatide) Injection[5].