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Last Updated: June 21, 2024

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PARSABIV Drug Patent Profile


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Which patents cover Parsabiv, and when can generic versions of Parsabiv launch?

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

This drug has one hundred and three patent family members in forty-four 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 have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for PARSABIV
Drug Prices for PARSABIV

See drug prices for PARSABIV

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
AmgenPhase 3

See all PARSABIV clinical trials

Pharmacology for PARSABIV
Paragraph IV (Patent) Challenges for PARSABIV
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 PARSABIV

PARSABIV is protected by seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PARSABIV is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting PARSABIV

Stable liquid formulation of AMG 416 (etelcalcetide)
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Therapeutic agents for reducing parathyroid hormone levels
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Therapeutic agents for reducing parathyroid hormone levels
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT)

Therapeutic agents for reducing parathyroid hormone levels
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Therapeutic agents for reducing parathyroid hormone levels
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT)

Stable liquid formulation of AMG 416 (etelcalcetide)
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 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 208325-001 Feb 7, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
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 208325-002 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
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-002 Feb 7, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y 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 PARSABIV

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 PARSABIV

When does loss-of-exclusivity occur for PARSABIV?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 6773
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 14302122
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015032615
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 16222
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 15003738
Estimated Expiration: ⤷  Sign Up

China

Patent: 5764487
Estimated Expiration: ⤷  Sign Up

Patent: 4376970
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 160002
Estimated Expiration: ⤷  Sign Up

Patent: 160061
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0171092
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 20811
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 13318
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 0220
Estimated Expiration: ⤷  Sign Up

Patent: 1690099
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 13318
Estimated Expiration: ⤷  Sign Up

Patent: 46017
Estimated Expiration: ⤷  Sign Up

Patent: 78433
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 22557
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 34209
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 3210
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 27708
Estimated Expiration: ⤷  Sign Up

Patent: 16523916
Estimated Expiration: ⤷  Sign Up

Jordan

Patent: 17
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 13318
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 0276
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 15017952
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 818
Estimated Expiration: ⤷  Sign Up

Morocco

Patent: 724
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 5403
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 160549
Estimated Expiration: ⤷  Sign Up

Patent: 210413
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 015502816
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 13318
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 13318
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 238
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201510647T
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 13318
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1600238
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2231957
Estimated Expiration: ⤷  Sign Up

Patent: 160043954
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 33989
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 35874
Estimated Expiration: ⤷  Sign Up

Patent: 1542239
Estimated Expiration: ⤷  Sign Up

Tunisia

Patent: 15000569
Estimated Expiration: ⤷  Sign Up

Ukraine

Patent: 5373
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 636
Estimated Expiration: ⤷  Sign Up

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering PARSABIV around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1222557 的穩定的液體製劑 (STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE) AMG 416(VELCALCETIDE)) ⤷  Sign Up
Russian Federation 2557654 ТЕРАПЕВТИЧЕСКИЕ АГЕНТЫ ДЛЯ СНИЖЕНИЯ УРОВНЕЙ ПАРАТИРЕОИДНОГО ГОРМОНА (THERAPEUTIC AGENTS FOR REDUCTION OF PARATHYROID HORMONE LEVELS) ⤷  Sign Up
Croatia P20161614 ⤷  Sign Up
Costa Rica 20160002 FORMULACIÓN ESTABLE LÍQUIDA DE ETELCALCETIDE (AMG 461) ⤷  Sign Up
Turkey 201907941 ⤷  Sign Up
Poland 2459208 ⤷  Sign Up
Brazil 112012002143 agentes terapêuticos para redução dos níveis de hormônio da paratieóide. ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PARSABIV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2459208 C02459208/01 Switzerland ⤷  Sign Up PRODUCT NAME: ETELCALCETID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66338 27.09.2017
2459208 387 50003-2017 Slovakia ⤷  Sign Up PRODUCT NAME: ETELKALCETID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1142/001 - EU/1/16/1142/012 20161115
2459208 1790012-7 Sweden ⤷  Sign Up PRODUCT NAME: ETELCALCETIDE, OR SALT THEREOF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208 122017000021 Germany ⤷  Sign Up PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208 PA2017007 Lithuania ⤷  Sign Up PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208 17C1009 France ⤷  Sign Up 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 8/2017 Austria ⤷  Sign Up PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON EINSCHLIESSLICH ETELCALCETID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 (MITTEILUNG) 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.