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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 etelcalcetide 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etelcalcetide has sixty-nine patent family members in thirty-seven countries.

One supplier is listed for this compound.

Summary for etelcalcetide

International Patents:	69
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	4
Clinical Trials:	5
Drug Prices:	Drug price information for etelcalcetide
DailyMed Link:	etelcalcetide at DailyMed

Pharmacology for etelcalcetide

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

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	208325-002	Feb 7, 2017		RX	Yes	Yes
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	208325-003	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes			Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	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

International Patents for etelcalcetide

Country	Document Number	Estimated Expiration
Israel	217749
Hong Kong	1222557
Lithuania	2459208
Japan	2013500990
Taiwan	201542239
Denmark	2459208
Lithuania	PA2017007

Supplementary Protection Certificates for etelcalcetide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2017007	Lithuania		PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
0170006 00208	Estonia		PRODUCT NAME: ETELKALTSETIID;REG NO/DATE: EU/1/16/1142 15.11.2016
0864	Netherlands		PRODUCT NAME: ETELCALCETIDE OF EEN ZOUT DAARVAN, MET INBEGRIP VAN ETELCALCETIDEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1142/001-012 20161115
2017	Austria		PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON EINSCHLIESSLICH ETELCALCETID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 (MITTEILUNG) 20161115
2017000021	Germany		PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON, EINSCHLIESSLICH ETELCALCETIDHYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2017 00006	Denmark		PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115