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Last Updated: May 16, 2021

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PARSABIV Drug Profile

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Which patents cover Parsabiv, 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 and one Paragraph IV challenge.

This drug has ninety-one 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.

DrugPatentWatch® Generic Entry Outlook for Parsabiv

Parsabiv was eligible for patent challenges on February 7, 2021.

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

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for PARSABIV
International Patents:91
US Patents:6
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 14
Clinical Trials: 2
Drug Prices: Drug price information for PARSABIV
What excipients (inactive ingredients) are in PARSABIV?PARSABIV excipients list
DailyMed Link:PARSABIV at DailyMed
Drug patent expirations by year for PARSABIV
Drug Prices for PARSABIV

See drug prices for PARSABIV

DrugPatentWatch® Estimated 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
Prim. Priv. Doz. Dr. Daniel CejkaPhase 2
AmgenPhase 2
Thomas Nickolas, MD MSPhase 2

See all PARSABIV clinical trials

Pharmacology for PARSABIV
Paragraph IV (Patent) Challenges for PARSABIV
Tradename Dosage Ingredient NDA Submissiondate
PARSABIV SOLUTION;INTRAVENOUS etelcalcetide 208325 2021-02-08

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   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-003 Feb 7, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-001 Feb 7, 2017 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-001 Feb 7, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-002 Feb 7, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-003 Feb 7, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-002 Feb 7, 2017 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for PARSABIV

Country Patent Number Estimated Expiration
Eurasian Patent Organization 201690099   Get Started for $10
Spain 2729051   Get Started for $10
Japan 2013500990   Get Started for $10
Lithuania PA2017007   Get Started for $10
Brazil 112012002143   Get Started for $10
Eurasian Patent Organization 030220   Get Started for $10
South Korea 20120104513   Get Started for $10
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for PARSABIV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2459208 17C1009 France   Get Started for $10 PRODUCT NAME: ETELCALCETIDE, OU UN SEL DE CELUI-CI, NOTAMMENT LE CHLORHYDRATE D'ETELCALCETIDE; REGISTRATION NO/DATE: EU/1/16/1142/001-012 20161115
2459208 CR 2017 00006 Denmark   Get Started for $10 PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208 8/2017 Austria   Get Started for $10 PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON EINSCHLIESSLICH ETELCALCETID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 (MITTEILUNG) 20161115
2459208 CA 2017 00006 Denmark   Get Started for $10 PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208 C20170006 00208 Estonia   Get Started for $10 PRODUCT NAME: ETELKALTSETIID;REG NO/DATE: EU/1/16/1142 15.11.2016
2459208 132017000041085 Italy   Get Started for $10 PRODUCT NAME: ETELCALCETIDE, O UN SUO SALE, COMPRESO ETELCALCETIDE IDROCLORURO(PARSABIV); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1142/001-012, 20161115
2459208 1790012-7 Sweden   Get Started for $10 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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