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Last Updated: June 20, 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 three 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
AmgenPhase 2
Prim. Priv. Doz. Dr. Daniel CejkaPhase 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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-001 Feb 7, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-003 Feb 7, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-003 Feb 7, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 3192520 ⤷  Sign Up
Israel 217749 גורמים טיפוליים להורדת רמות הורמון יותרת התריס (Therapeutic agents for reducing parathyroid hormone levels) ⤷  Sign Up
Philippines 12015502816 STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE) ⤷  Sign Up
Hong Kong 1167108 用於降低甲狀旁腺激素水平的治療劑 (THERAPEUTIC AGENTS FOR REDUCING PARATHYROID HORMONE LEVELS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ETELCALCETIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2459208 8/2017 Austria ⤷  Sign Up PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON EINSCHLIESSLICH ETELCALCETID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 (MITTEILUNG) 20161115
2459208 LUC00008 Luxembourg ⤷  Sign Up PRODUCT NAME: ETELCALCETIDE, OU UN SEL EQUIVALENT, Y COMPRIS LE CHLORHYDRATE D'ETELCALCETIDE (PARSABIV); AUTHORISATION NUMBER AND DATE: EU/1/16/1142 20161115
2459208 654 Finland ⤷  Sign Up
2459208 CR 2017 00006 Denmark ⤷  Sign Up PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; 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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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.