➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Colorcon
Dow
Boehringer Ingelheim
McKesson
Johnson and Johnson
Express Scripts

Last Updated: April 14, 2021

DrugPatentWatch Database Preview

Cinacalcet hydrochloride - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

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, 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 fourteen 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 seventy-seven patent family members in twenty-eight countries.

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

Summary for cinacalcet hydrochloride
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 Hakko Kirin China Pharmaceutical Co., LTD.Phase 3

See all cinacalcet hydrochloride clinical trials

Generic filers with tentative approvals for CINACALCET HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial90MGTABLET; ORAL
  Start Trial  Start Trial60MGTABLET; ORAL
  Start Trial  Start Trial30MGTABLET; 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 NDA Submissiondate
SENSIPAR TABLET;ORAL cinacalcet hydrochloride 021688 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
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Lupin Ltd CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210548-001 Jun 28, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 208368-001 Sep 18, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Acme Labs CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 213325-003 May 18, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 208915-003 Mar 8, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd V CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 209403-001 Oct 7, 2020 AB RX No No   Start Trial   Start Trial   Start 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004   Start Trial   Start Trial
>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   Start Trial PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
1203761 C01203761/01 Switzerland   Start Trial PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
1203761 SPC/GB05/031 United Kingdom   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Harvard Business School
Baxter
Merck
Mallinckrodt
McKesson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.