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Last Updated: April 26, 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.

Summary for etelcalcetide

International Patents:	103
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	19
Patent Applications:	146
Drug Prices:	Drug price trends for etelcalcetide
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for etelcalcetide
What excipients (inactive ingredients) are in etelcalcetide?	etelcalcetide excipients list
DailyMed Link:	etelcalcetide at DailyMed

See drug prices for etelcalcetide

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

Generic Entry Date for etelcalcetide^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Sponsor	Phase
Prim. Priv. Doz. Dr. Daniel Cejka	Phase 2
Amgen	Phase 2
Thomas Nickolas, MD MS	Phase 2

See all etelcalcetide clinical trials

Pharmacology for etelcalcetide

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

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

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Glossary

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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	208325-002	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			⤷ 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	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			⤷ 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 etelcalcetide

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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

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Country	Patent Number	Title	Estimated Expiration
Taiwan	I635874		⤷ Try a Trial
Japan	6027708		⤷ Try a Trial
Croatia	P20161614		⤷ Try a Trial
Russian Federation	2012107428	ТЕРАПЕВТИЧЕСКИЕ АГЕНТЫ ДЛЯ СНИЖЕНИЯ УРОВНЕЙ ПАРАТИРЕОИДНОГО ГОРМОНА	⤷ Try a Trial
Spain	2607954		⤷ Try a Trial
Portugal	3192520		⤷ 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 etelcalcetide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2459208	PA2017007	Lithuania	⤷ Try a Trial	PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
2459208	CR 2017 00006	Denmark	⤷ Try a Trial	PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
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	PA2017007,C2459208	Lithuania	⤷ Try a Trial	PRODUCT NAME: ETELKALCETIDAS ARBA JO DRUSKA, ISKAITANT ETELKALCETIDO HIDROCHLORIDA; REGISTRATION NO/DATE: EU/1/16/1142 20161111
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
2459208	CA 2017 00006	Denmark	⤷ Try a Trial	PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208	387 50003-2017	Slovakia	⤷ Try a Trial	PRODUCT NAME: ETELKALCETID VO VSETKYCH FORMACH CHRANENYCH ZAKLADNYM PATENTOM; REGISTRATION NO/DATE: EU/1/16/1142/001 - EU/1/16/1142/012 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.