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Etelcalcetide - Generic Drug Details

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What are the generic sources for etelcalcetide and what is the scope of freedom to operate?

Etelcalcetide is the generic ingredient in one branded drug marketed by Kai Pharms Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etelcalcetide has ninety patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for etelcalcetide

International Patents:	90
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	11
Clinical Trials:	7
Drug Prices:	Drug price trends for etelcalcetide
DailyMed Link:	etelcalcetide at DailyMed

See drug prices for etelcalcetide

Recent Clinical Trials for etelcalcetide

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Amgen	Phase 2
Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2
Thomas Nickolas, MD MS	Phase 2

See all etelcalcetide clinical trials

Pharmacology for etelcalcetide

Drug Class	Calcium-sensing Receptor Agonist
Mechanism of Action	Increased Calcium-sensing Receptor Sensitivity

Synonyms for etelcalcetide

1262780-97-1

60ME133FJB

AMG 416

AMG-416

CHEBI:134700

CHEMBL3545184

D-Argininamide, N-acetyl-D-cysteinyl-D-alanyl-D-arginyl-D-arginyl-D-arginyl-D-alanyl-, disulfide with L-cysteine

D10676

DB12865

DTXSID70155132

Etelcalcetide (USAN/INN)

Etelcalcetide [USAN:INN]

Etelcalcetide Hydrochloride(AMG-416)

J3.559.823E

KAI 4169

KAI-4169

Parsabiv

UNII-60ME133FJB

Velcalcetide

US Patents and Regulatory Information for etelcalcetide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes			Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes				Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes			Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes			Y	Y

International Patents for etelcalcetide

Country	Patent Number	Estimated Expiration
Croatia	P20171092
South Korea	101781841
Japan	2014094967
Canada	2916222
Canada	2769525
Poland	2459208
Norway	2017021

Supplementary Protection Certificates for etelcalcetide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2459208	CA 2017 00006	Denmark		PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208	122017000021	Germany		PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON, EINSCHLIESSLICH ETELCALCETIDHYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208	8/2017	Austria		PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON EINSCHLIESSLICH ETELCALCETID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 (MITTEILUNG) 20161115
2459208	300864	Netherlands		PRODUCT NAME: ETELCALCETIDE OF EEN ZOUT DAARVAN, MET INBEGRIP VAN ETELCALCETIDEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1142/001-012 20161115
2459208	C02459208/01	Switzerland		PRODUCT NAME: ETELCALCETID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66338 27.09.2017
2459208	2017021	Norway		PRODUCT NAME: ETELKALSETID, ELLER ET SALT DERAV, INKLUDERT ETELKALSETIDHYDROKLORID; NAT. REG. NO/DATE: EU/1/16/1142 20161122; FIRST REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208	1790012-7	Sweden		PRODUCT NAME: ETELCALCETIDE, OR SALT THEREOF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1142/001-012 20161115