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 eight 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:	8
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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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
Amgen	Phase 2
Prim. Priv. Doz. Dr. Daniel Cejka	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

Anatomical Therapeutic Chemical (ATC) Classes for etelcalcetide

H05BX	Other anti-parathyroid agents
H05B	ANTI-PARATHYROID AGENTS
H05	CALCIUM HOMEOSTASIS
H	Systemic hormonal preparations, excluding sex hormones and insulins

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	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y			⤷ Subscribe
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-002	Feb 7, 2017		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Kai Pharms Inc	PARSABIV	etelcalcetide	SOLUTION;INTRAVENOUS	208325-001	Feb 7, 2017		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe		Y		⤷ Subscribe
>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
Russian Federation	2557654	ТЕРАПЕВТИЧЕСКИЕ АГЕНТЫ ДЛЯ СНИЖЕНИЯ УРОВНЕЙ ПАРАТИРЕОИДНОГО ГОРМОНА (THERAPEUTIC AGENTS FOR REDUCTION OF PARATHYROID HORMONE LEVELS)	⤷ Subscribe
Hungary	E030960		⤷ Subscribe
China	105764487	AMG 416（VELCALCETIDE）的稳定的液体制剂 (STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE))	⤷ Subscribe
China	114376970	Etelcalcetide (AMG 416)的稳定的液体制剂 (Stable liquid formulations of Etelcalcetide (AMG 416))	⤷ Subscribe
Chile	2015003738	Formulación líquida estable de amg-416 (velcalcetida)	⤷ Subscribe
South Africa	201600238	STABLE LIQUID FORMULATION OF AMG 416 (VELCALCETIDE)	⤷ Subscribe
>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	1790012-7	Sweden	⤷ Subscribe	PRODUCT NAME: ETELCALCETIDE, OR SALT THEREOF, INCLUDING ETELCALCETIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/16/1142/001-012 20161115
2459208	2017021	Norway	⤷ Subscribe	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	LUC00008	Luxembourg	⤷ Subscribe	PRODUCT NAME: ETELCALCETIDE, OU UN SEL EQUIVALENT, Y COMPRIS LE CHLORHYDRATE D'ETELCALCETIDE (PARSABIV); AUTHORISATION NUMBER AND DATE: EU/1/16/1142 20161115
2459208	8/2017	Austria	⤷ Subscribe	PRODUCT NAME: ETELCALCETID ODER EIN SALZ DAVON EINSCHLIESSLICH ETELCALCETID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/16/1142 (MITTEILUNG) 20161115
2459208	C02459208/01	Switzerland	⤷ Subscribe	PRODUCT NAME: ETELCALCETID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66338 27.09.2017
2459208	CA 2017 00006	Denmark	⤷ Subscribe	PRODUCT NAME: ETELCALCETID ELLER ET SALT DERAF, INKLUSIV ETELCALCETIDHYDROCHLORID; REG. NO/DATE: EU/1/16/1142/001-012 20161115
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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