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PARSABIV Drug Patent Profile

When do Parsabiv patents expire, and what generic alternatives are available?

Parsabiv is a drug marketed by Kai Pharms Inc and is included in one NDA. There are eight 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

Summary for PARSABIV

International Patents:	103
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	4
Patent Applications:	39
Drug Prices:	Drug price information for PARSABIV
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PARSABIV
What excipients (inactive ingredients) are in PARSABIV?	PARSABIV excipients list
DailyMed Link:	PARSABIV at DailyMed

See drug prices for PARSABIV

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for PARSABIV

NDA:

208325

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

Sponsor	Phase
Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2
Amgen	Phase 2
Amgen	Phase 3

See all PARSABIV clinical trials

Pharmacology for PARSABIV

Drug Class	Calcium-sensing Receptor Agonist
Mechanism of Action	Increased Calcium-sensing Receptor Sensitivity

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 eight US patents.

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

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			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-003	Feb 7, 2017		RX	Yes	Yes			Y	Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes			Y

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

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

Australia

Brazil

Canada

Chile

China

Costa Rica

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

Hong Kong

Hungary

Israel

Japan

Jordan

Lithuania

Malaysia

Mexico

Montenegro

Morocco

New Zealand

Peru

Philippines

Poland

Portugal

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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
Japan	2013500990
Lithuania	PA2017007
Costa Rica	20160061	FORMULACIÓN ESTABLE LÍQUIDA DE ETELCALCETIDE (AMG 461)
Slovenia	3013318
China	107674114	用于降低甲状旁腺激素水平的治疗剂 (Therapeutic Agents For Reducing Parathyroid Hormone Levels)

Supplementary Protection Certificates for PARSABIV

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2459208	132017000041085	Italy		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	654	Finland
2459208	C20170006 00208	Estonia		PRODUCT NAME: ETELKALTSETIID;REG NO/DATE: EU/1/16/1142 15.11.2016
2459208	387 50003-2017	Slovakia		PRODUCT NAME: ETELKALCETID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1142/001 - EU/1/16/1142/012 20161115
2459208	17C1009	France		PRODUCT NAME: ETELCALCETIDE, OU UN SEL DE CELUI-CI, NOTAMMENT LE CHLORHYDRATE D'ETELCALCETIDE; REGISTRATION NO/DATE: EU/1/16/1142/001-012 20161115