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Last Updated: March 19, 2024

Cinacalcet hydrochloride - Generic Drug Details


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What are the generic 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
VA Office of Research and DevelopmentPhase 4
University of California, San FranciscoPhase 4

See all cinacalcet hydrochloride clinical trials

Generic filers with tentative approvals for CINACALCET HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial30MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial90MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial60MGTABLET; 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
Watson Labs Teva CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 204377-001 Dec 27, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Slate Run Pharma CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210207-001 Aug 1, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Chartwell Rx CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 213325-001 May 18, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 206125-003 Mar 8, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd V CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 209403-003 Oct 7, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurobindo Pharma Ltd CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 206125-002 Mar 8, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

Expired US Patents for cinacalcet hydrochloride

International Patents for cinacalcet hydrochloride

Country Patent Number Title Estimated Expiration
Japan 2007505108 ⤷  Try a Trial
Slovenia 3395339 ⤷  Try a Trial
Turkey 201910180 ⤷  Try a Trial
Portugal 3395339 ⤷  Try a Trial
European Patent Office 2316442 COMPOSITION A BASE DE CINACALCET HCL, A VITESSE DE DISSOLUTION RAPIDE (RAPID DISSOLUTION FORMULATION OF CINACALCET HCL) ⤷  Try a Trial
Turkey 201909267 ⤷  Try a Trial
Portugal 3395340 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for cinacalcet hydrochloride

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

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