CINACALCET HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for cinacalcet hydrochloride and what is the scope of patent protection?

Cinacalcet hydrochloride is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Alkem Labs Ltd, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, Norvium Bioscience, Slate Run Pharma, Stevens J, Strides Pharma, Sun Pharm, Watson Labs Teva, and Amgen, and is included in fifteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Cinacalcet hydrochloride has eighty-one patent family members in twenty-nine countries.

There are twenty-two drug master file entries for cinacalcet hydrochloride. Twenty suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for CINACALCET HYDROCHLORIDE

International Patents:	81
US Patents:	2
Tradenames:	2
Applicants:	15
NDAs:	15
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	62
Patent Applications:	298
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CINACALCET HYDROCHLORIDE
What excipients (inactive ingredients) are in CINACALCET HYDROCHLORIDE?	CINACALCET HYDROCHLORIDE excipients list
DailyMed Link:	CINACALCET HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CINACALCET HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Shanghai Hengrui Pharmaceutical Co., Ltd.	Phase 2
University of California, San Francisco	Phase 4
VA Office of Research and Development	Phase 4

See all CINACALCET HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for CINACALCET HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	90MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	60MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	30MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for CINACALCET HYDROCHLORIDE

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

Medical Subject Heading (MeSH) Categories for CINACALCET HYDROCHLORIDE

Calcimimetic Agents

Anatomical Therapeutic Chemical (ATC) Classes for CINACALCET HYDROCHLORIDE

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 CINACALCET HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SENSIPAR	Tablets	cinacalcet hydrochloride	30 mg, 60 mg and 90 mg	021688	1	2008-03-10

US Patents and Regulatory Information for CINACALCET HYDROCHLORIDE

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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
Cipla	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	208915-002	Mar 8, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	208368-001	Sep 18, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Stevens J	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	204364-003	Dec 2, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm	CINACALCET HYDROCHLORIDE	cinacalcet hydrochloride	TABLET;ORAL	207008-001	Oct 11, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for CINACALCET HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	⤷ Sign Up	⤷ Sign Up
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-002	Mar 8, 2004	⤷ Sign Up	⤷ Sign Up
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-001	Mar 8, 2004	⤷ Sign Up	⤷ Sign Up
Amgen	SENSIPAR	cinacalcet hydrochloride	TABLET;ORAL	021688-003	Mar 8, 2004	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for CINACALCET HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Poland	3260117		⤷ Sign Up
Cyprus	1119609		⤷ Sign Up
Denmark	1663182		⤷ Sign Up
Eurasian Patent Organization	013425	БЫСТРОРАСТВОРИМАЯ ЛЕКАРСТВЕННАЯ ФОРМА СОЕДИНЕНИЯ, ДЕЙСТВУЮЩЕГО НА КАЛЬЦИЕВЫЙ РЕЦЕПТОР (RAPID DISSOLUTION FORMULATION OF A CALCIUM RECEPTOR-ACTIVE COMPOUND)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CINACALCET HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1203761	05C0029	France	⤷ Sign Up	PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
1203761	C01203761/01	Switzerland	⤷ Sign Up	PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
1203761	SPC/GB05/031	United Kingdom	⤷ Sign Up	PRODUCT NAME: CINACALCET OR A PHARMACEUTICALLY ACCEPTABLE SALT OR COMPLEX THEREOF; REGISTERED: UK EU/1/04/292/001 20041022; UK EU/1/04/292/002 20041022; UK EU/1/04/292/003 20041022; UK EU/1/04/292/004 20041022; UK EU/1/04/292/005 20041022; UK EU/1/04/292/006 20041022; UK EU/1/04/292/007 20041022; UK EU/1/04/292/008 20041022; UK EU/1/04/292/009 20041022; UK EU/1/04/292/010 20041022; UK EU/1/04/292/011 20041022; UK EU/1/04/292/012 20041022; UK EU/1/04/293/001 20041022; UK EU/1/04/293/002 20041022; UK EU/1/04/293/003 20041022; UK EU/1/04/293/004 20041022; UK EU/1/04/293/005 20041022; UK EU/1/04/293/006 20041022; UK EU/1/04/293/007 20041022; UK EU/1/04/293/008 20041022; UK EU/1/04/293/009 200410
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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