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Last Updated: January 18, 2020

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PARSABIV Drug Profile

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When do Parsabiv patents expire, and what generic alternatives are available?

Parsabiv is a drug marketed by Kai Pharms Inc and is included in one NDA. There are six patents protecting this drug.

This drug has ninety patent family members in forty-one countries.

The generic ingredient in PARSABIV is etelcalcetide. One supplier is listed for this compound. Additional details are available on the etelcalcetide profile page.

US ANDA Litigation and Generic Entry Outlook for Parsabiv

  Start Trial

Parsabiv will be eligible for patent challenges on February 7th, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 27th, 2034. This may change due to patent challenges or generic licensing.

Summary for PARSABIV
International Patents:90
US Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Bulk Api Vendors: 6
Clinical Trials: 2
Drug Prices: Drug price information for PARSABIV
DailyMed Link:PARSABIV at DailyMed
Drug patent expirations by year for PARSABIV
Drug Prices for PARSABIV

See drug prices for PARSABIV

Generic Entry Opportunity Date for PARSABIV
Generic Entry Date for PARSABIV*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;INTRAVENOUS

*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 PARSABIV

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 PARSABIV clinical trials

Pharmacology for PARSABIV
Synonyms for PARSABIV
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
Etelcalcetide (USAN/INN)
Etelcalcetide [USAN:INN]
Etelcalcetide Hydrochloride(AMG-416)
J3.559.823E
KAI 4169
KAI-4169
UNII-60ME133FJB
Velcalcetide

US Patents and Regulatory Information for PARSABIV

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 208325-001 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   Start Trial
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-001 Feb 7, 2017 RX Yes Yes   Start Trial   Start Trial   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 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
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-002 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 PARSABIV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2459208 122017000021 Germany   Start Trial PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON, EINSCHLIESSLICH ETELCALCETIDHYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208 C20170006 00208 Estonia   Start Trial PRODUCT NAME: ETELKALTSETIID;REG NO/DATE: EU/1/16/1142 15.11.2016
2459208 PA2017007 Lithuania   Start Trial PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
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
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 LUC00008 Luxembourg   Start Trial PRODUCT NAME: ETELCALCETIDE, OU UN SEL EQUIVALENT, Y COMPRIS LE CHLORHYDRATE D'ETELCALCETIDE (PARSABIV); AUTHORISATION NUMBER AND DATE: EU/1/16/1142 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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