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Last Updated: July 18, 2024

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, Mylan, 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.

Recent Clinical Trials for cinacalcet hydrochloride

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

SponsorPhase
Shanghai Hengrui Pharmaceutical Co., Ltd.Phase 2
University of California, San FranciscoPhase 4
VA Office of Research and DevelopmentPhase 4

See all cinacalcet hydrochloride clinical trials

Generic filers with tentative approvals for CINACALCET HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up90MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up60MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up30MGTABLET; 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
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
Dr Reddys CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 208368-002 Sep 18, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Slate Run Pharma CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210207-003 Aug 1, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd V CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 209403-002 Oct 7, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma Ltd CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 206125-003 Mar 8, 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

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

Supplementary Protection Certificates for cinacalcet hydrochloride

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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