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Last Updated: January 28, 2020

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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
Drug Prices for etelcalcetide

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Recent Clinical Trials for etelcalcetide

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

SponsorPhase
AmgenPhase 2
Prim. Priv. Doz. Dr. Daniel CejkaPhase 2
Thomas Nickolas, MD MSPhase 2

See all etelcalcetide clinical trials

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

Supplementary Protection Certificates for etelcalcetide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2459208 CA 2017 00006 Denmark   Start Trial PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208 122017000021 Germany   Start Trial PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON, EINSCHLIESSLICH ETELCALCETIDHYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208 8/2017 Austria   Start Trial PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON EINSCHLIESSLICH ETELCALCETID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 (MITTEILUNG) 20161115
2459208 300864 Netherlands   Start Trial 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   Start Trial PRODUCT NAME: ETELCALCETID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66338 27.09.2017
2459208 2017021 Norway   Start Trial 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   Start Trial PRODUCT NAME: ETELCALCETIDE, OR SALT THEREOF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1142/001-012 20161115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Boehringer Ingelheim
Colorcon
Moodys
Harvard Business School
Express Scripts

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