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Last Updated: March 29, 2024

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PARSABIV Drug Patent 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 seven patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and one 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
Prim. Priv. Doz. Dr. Daniel CejkaPhase 2
AmgenPhase 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Therapeutic agents for reducing parathyroid hormone levels
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Therapeutic agents for reducing parathyroid hormone levels
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

Stable liquid formulation of AMG 416 (etelcalcetide)
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-001 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 208325-001 Feb 7, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-001 Feb 7, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-002 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 208325-002 Feb 7, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y 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 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: ⤷  Try a Trial

Australia

Patent: 14302122
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2015032615
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 16222
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 15003738
Estimated Expiration: ⤷  Try a Trial

China

Patent: 5764487
Estimated Expiration: ⤷  Try a Trial

Patent: 4376970
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 160002
Estimated Expiration: ⤷  Try a Trial

Patent: 160061
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0171092
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 20811
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 13318
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 0220
Estimated Expiration: ⤷  Try a Trial

Patent: 1690099
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 13318
Estimated Expiration: ⤷  Try a Trial

Patent: 46017
Estimated Expiration: ⤷  Try a Trial

Patent: 78433
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 22557
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 34209
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 3210
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 27708
Estimated Expiration: ⤷  Try a Trial

Patent: 16523916
Estimated Expiration: ⤷  Try a Trial

Jordan

Patent: 17
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 13318
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 0276
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 15017952
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 818
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 724
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 5403
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 160549
Estimated Expiration: ⤷  Try a Trial

Patent: 210413
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 015502816
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 13318
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 13318
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 238
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201510647T
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 13318
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1600238
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 2231957
Estimated Expiration: ⤷  Try a Trial

Patent: 160043954
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 33989
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 35874
Estimated Expiration: ⤷  Try a Trial

Patent: 1542239
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 15000569
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 5373
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 636
Estimated Expiration: ⤷  Try a Trial

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
Eurasian Patent Organization 030220 УСТОЙЧИВАЯ ЖИДКАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ AMG-416 (ЭТЕЛКАЛЦЕТИД) (STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE)) ⤷  Try a Trial
South Africa 201200726 THERAPEUTIC AGENTS FOR REDUCING PARATHYROID HORMONE LEVELS ⤷  Try a Trial
Lithuania 2459208 ⤷  Try a Trial
Japan 2016523916 安定な液体製剤 ⤷  Try a Trial
European Patent Office 3192520 AGENTS THÉRAPEUTIQUES DE RÉDUCTION DES NIVEAUX D'HORMONE PARATHYROÏDE (THERAPEUTIC AGENTS FOR REDUCING PARATHYROID HORMONE LEVELS) ⤷  Try a Trial
Costa Rica 20160061 FORMULACIÓN ESTABLE LÍQUIDA DE ETELCALCETIDE (AMG 461) ⤷  Try a Trial
Ukraine 115373 СТАБІЛЬНИЙ РІДКИЙ СКЛАД AMG 416 (ВЕЛКАЛСЕТИДУ) (STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE)) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PARSABIV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2459208 SPC/GB17/018 United Kingdom ⤷  Try a Trial PRODUCT NAME: ETELCALCETIDE, OR A SALT THEROF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REGISTERED: UK EU/1/16/1142/001-012 20161115; UK PLGB 13832/0039 20161115; UK PLGB 13832/0040 20161115; UK PLGB 13832/0041 20161115
2459208 132017000041085 Italy ⤷  Try a Trial 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 2017021 Norway ⤷  Try a 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 PA2017007 Lithuania ⤷  Try a Trial PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208 PA2017007,C2459208 Lithuania ⤷  Try a Trial PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; 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 8/2017 Austria ⤷  Try a Trial 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.