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Last Updated: February 23, 2024

Etelcalcetide - Generic Drug Details


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What are the generic drug 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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etelcalcetide has one hundred and one patent family members in forty-four countries.

One supplier is listed for this compound.

Drug Prices for etelcalcetide

See drug prices for etelcalcetide

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for etelcalcetide
Generic Entry Date for etelcalcetide*:
Constraining patent/regulatory exclusivity:
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 etelcalcetide

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 etelcalcetide clinical trials

Pharmacology for etelcalcetide
Paragraph IV (Patent) Challenges for ETELCALCETIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
PARSABIV Injection etelcalcetide 2.5 mg/0.5 mL 5 mg/mL 10 mg/2 mL 208325 2 2021-02-08

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

EU/EMA Drug Approvals for etelcalcetide

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Amgen Europe B.V. Parsabiv etelcalcetide EMEA/H/C/003995
Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.
Authorised no no no 2016-11-11
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for etelcalcetide

Country Patent Number Title Estimated Expiration
Lithuania 3013318 ⤷  Try a Trial
Turkey 201907941 ⤷  Try a Trial
Canada 2916222 FORMULATION LIQUIDE STABLE D'AMG 416 (VELCALCETIDE) (STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE)) ⤷  Try a Trial
Singapore 11201510647T STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE) ⤷  Try a Trial
South Korea 102231957 ⤷  Try a Trial
Japan 5270799 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for etelcalcetide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2459208 CA 2017 00006 Denmark ⤷  Try a Trial PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208 387 50003-2017 Slovakia ⤷  Try a Trial PRODUCT NAME: ETELKALCETID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1142/001 - EU/1/16/1142/012 20161115
2459208 654 Finland ⤷  Try a Trial
2459208 122017000021 Germany ⤷  Try a Trial PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208 1790012-7 Sweden ⤷  Try a Trial PRODUCT NAME: ETELCALCETIDE, OR SALT THEREOF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208 PA2017007 Lithuania ⤷  Try a Trial PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Medtronic
Boehringer Ingelheim
Baxter
Merck
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.