OMONTYS Drug Patent Profile

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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 six patents protecting this drug.

This drug has one hundred and fourteen patent family members in thirty-four 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.

Indicators of Generic Entry

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Summary for OMONTYS

International Patents:	114
US Patents:	6
Applicants:	1
NDAs:	1
Clinical Trials:	18
DailyMed Link:	OMONTYS at DailyMed

Drug patent expirations by year for OMONTYS

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 six US patents.

Patents protecting OMONTYS

Peptides that bind to the erythropoietin receptor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE

Peptides that bind to the erythropoietin receptor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Erythropoietin receptor peptide formulations and uses
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Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE

Spacer moiety for poly (ethylene glycol) modified peptide based compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Erythropoietin receptor peptide formulations and uses
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE

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Glossary

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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	202799-005	Mar 27, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-004	Mar 27, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-006	Mar 27, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-003	Mar 27, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-004	Mar 27, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	OMONTYS PRESERVATIVE FREE	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-003	Mar 27, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Takeda Pharms Usa	OMONTYS	peginesatide acetate	SOLUTION;INTRAVENOUS, SUBCUTANEOUS	202799-007	Mar 27, 2012		DISCN	No	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for OMONTYS

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

International Patents for OMONTYS

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

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Country	Patent Number	Title	Estimated Expiration
China	1823088	Novel peptides that bind to the erythropoietin receptor	⤷ Sign Up
Slovenia	1625156		⤷ Sign Up
Israel	171782	PEPTIDE DIMERS WHICH COMPRISE POLYETHYLENE GLYCOL THAT BIND TO THE ERYTHROPOIETIN RECEPTOR, PHARMACEUTICAL COMPOSITIONS THEREOF AND USE THEREOF	⤷ Sign Up
Japan	4949844		⤷ Sign Up
European Patent Office	1629007	NOUVEAUX PEPTIDES SE FIXANT AU RECEPTEUR DE L'ERYTHROPOIETINE (NOVEL PEPTIDES THAT BIND TO THE ERYTHROPOIETIN RECEPTOR)	⤷ Sign Up
Serbia	51130	NOVI PEPTIDI KOJI SE VEZUJU ZA ERITROPOIETINSKI RECEPTOR (NOVEL PEPTIDES THAT BIND TO THE ERYTHROPOIETIN RECEPTOR)	⤷ Sign Up
Costa Rica	9570	FORMULACIONES Y USOS DEL PEPTIDO RECEPTOR DE ERITROPOYETINA	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration