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Last Updated: May 21, 2022

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, Acme Labs, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Hetero Labs Ltd V, Lupin Ltd, Mylan, Piramal Hlthcare Uk, 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-two suppliers are listed for this compound.

Recent Clinical Trials for cinacalcet hydrochloride

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

SponsorPhase
University of California, San FranciscoPhase 4
VA Office of Research and DevelopmentPhase 4
Kyowa Kirin Korea Co., Ltd.Phase 3

See all cinacalcet hydrochloride clinical trials

Pharmacology for cinacalcet hydrochloride
Medical Subject Heading (MeSH) Categories for cinacalcet hydrochloride
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 203422-003 Oct 16, 2018 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin Ltd CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210548-003 Jun 28, 2019 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Accord Hlthcare CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 211892-003 May 15, 2020 AB RX No No See Plans and Pricing See Plans and Pricing 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

Expired US Patents for cinacalcet hydrochloride

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

Supplementary Protection Certificates for cinacalcet hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1203761 C01203761/01 Switzerland See Plans and Pricing PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
1203761 SPC/GB05/031 United Kingdom See Plans and Pricing 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
1203761 05C0029 France See Plans and Pricing PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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