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Last Updated: June 27, 2022

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 ninety-nine patent family members in forty-three 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 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
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 and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of PARSABIV is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing


Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic agents for reducing parathyroid hormone levels
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic agents for reducing parathyroid hormone levels
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT)

Therapeutic agents for reducing parathyroid hormone levels
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Therapeutic agents for reducing parathyroid hormone levels
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD OF TREATING SECONDARY HYPERPARATHYROIDISM (SHPT)

Stable liquid formulation of AMG 416 (etelcalcetide)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting PARSABIV

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-003 Feb 7, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-003 Feb 7, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-001 Feb 7, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-001 Feb 7, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-002 Feb 7, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Kai Pharms Inc PARSABIV etelcalcetide SOLUTION;INTRAVENOUS 208325-003 Feb 7, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 14302122
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015032615
Estimated Expiration: See Plans and Pricing

Canada

Patent: 16222
Estimated Expiration: See Plans and Pricing

Chile

Patent: 15003738
Estimated Expiration: See Plans and Pricing

China

Patent: 5764487
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 160002
Estimated Expiration: See Plans and Pricing

Patent: 160061
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0171092
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20811
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 13318
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 0220
Estimated Expiration: See Plans and Pricing

Patent: 1690099
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 13318
Estimated Expiration: See Plans and Pricing

Patent: 46017
Estimated Expiration: See Plans and Pricing

Patent: 78433
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 22557
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 34209
Estimated Expiration: See Plans and Pricing

Israel

Patent: 3210
Estimated Expiration: See Plans and Pricing

Japan

Patent: 27708
Estimated Expiration: See Plans and Pricing

Patent: 16523916
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 17
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 13318
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 0276
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 15017952
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 818
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 724
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 5403
Estimated Expiration: See Plans and Pricing

Peru

Patent: 160549
Estimated Expiration: See Plans and Pricing

Patent: 210413
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 015502816
Estimated Expiration: See Plans and Pricing

Poland

Patent: 13318
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 13318
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 238
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201510647T
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 13318
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1600238
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2231957
Estimated Expiration: See Plans and Pricing

Patent: 160043954
Estimated Expiration: See Plans and Pricing

Spain

Patent: 33989
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 35874
Estimated Expiration: See Plans and Pricing

Patent: 1542239
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 15000569
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 5373
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 636
Estimated Expiration: See Plans and Pricing

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
Australia 2014302122 Stable liquid formulation of AMG 416 (Velcalcetide) See Plans and Pricing
Portugal 3192520 See Plans and Pricing
Hungary S1700008 See Plans and Pricing
Montenegro 02818 STAB ILNA TEČNA FORMULACIJA AMG 416 (VELKALCETIDA) (STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE)) See Plans and Pricing
Philippines 12015502816 STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE) See Plans and Pricing
Poland 2459208 See Plans and Pricing
Israel 243210 פורמולציה רוקחית יציבה של amg416(וולקלצטיד) (Stable liquid formulation of amg 416(velcalcetide)) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for PARSABIV

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2459208 300864 Netherlands See Plans and Pricing PRODUCT NAME: ETELCALCETIDE OF EEN ZOUT DAARVAN, MET INBEGRIP VAN ETELCALCETIDEHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/16/1142/001-012 20161115
2459208 CR 2017 00006 Denmark See Plans and Pricing PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208 CA 2017 00006 Denmark See Plans and Pricing PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208 1790012-7 Sweden See Plans and Pricing PRODUCT NAME: ETELCALCETIDE, OR SALT THEREOF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208 132017000041085 Italy See Plans and Pricing 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 PA2017007 Lithuania See Plans and Pricing PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208 C20170006 00208 Estonia See Plans and Pricing PRODUCT NAME: ETELKALTSETIID;REG NO/DATE: EU/1/16/1142 15.11.2016
>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.