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Last Updated: May 25, 2020

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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 Alkem Labs Ltd, Aurobindo Pharma Ltd, Cipla, Lupin Ltd, Mylan, Piramal Hlthcare Uk, Strides Pharma, Sun Pharm, Watson Labs Teva, and Amgen, and is included in ten 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. Twelve 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
VA Office of Research and DevelopmentPhase 4
University of California, San FranciscoPhase 4
Kyowa Hakko Kirin Co., LtdPhase 3

See all cinacalcet hydrochloride clinical trials

Recent Litigation for cinacalcet hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Amgen Inc. v. The ACME Laboratories Ltd.2019-09-11
Amgen Inc. v. Emcure Pharmaceuticals Ltd.2018-09-07
AMGEN INC. v. ACCORD HEALTHCARE, INC.2018-06-29

See all cinacalcet hydrochloride litigation

PTAB Litigation
PetitionerDate
2015-10-26

See all cinacalcet hydrochloride litigation

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
Synonyms for cinacalcet hydrochloride
(R)-N-(1-(Naphthalen-1-yl)ethyl)-3-(3-(trifluoro-methyl)phenyl)propan-1-amine hydrochloride
(R)-N-(1-(Naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine hydrochloride
[(1R)-1-(naphthalen-1-yl)ethyl]({3-[3-(trifluoromethyl)phenyl]propyl})amine hydrochloride
1-Naphthalenemethanamine, alpha-methyl-N-(3-(3-(trifluoromethyl)phenyl)propyl)-, (alphaR)-, hydrochloride
1-Naphthalenemethanamine, alpha-methyl-N-[3-[3-(trifluoromethyl)phenyl]propyl]-, hydrochloride (1:1), (alphaR)-
1217809-88-5
1K860WSG25
364782-34-3
782C343
AB0031566
ABP000405
AC-1799
AK-64582
AKOS005146514
AKOS015969126
AM90312
AMG 073
AMG 073 HCl
AMG-073 HCL
AMG-073 HCl (Cinacalcet hydrochloride)
AMG-073 hydrochloride
AMG-073.HCl
AMG073 HCl
AMG073 hydrochloride
API0006427
AX8213065
BCP02533
BCP9000286
BCPP000409
BR-64582
C22H22F3N.HCl
CAS-364782-34-3
CC0163
CHEBI:48391
CHEMBL1200776
Cinacalcet (hydrochloride)
Cinacalcet HCl
Cinacalcet hydrochloride (JAN/USAN)
Cinacalcet hydrochloride [USAN]
Cinacalcet hydrochloride/AMG073/Mimpara, Cinacalcet hydrochloride, Sensipar/
Cinacalcet, HCl
Cinacelcet hydrochloride
CNC-HCl
CS-0288
D03505
DSSTox_CID_26792
DSSTox_GSID_46792
DSSTox_RID_81909
DTXSID3046792
FT-0655073
GS-4171
HY-70037A
J-520045
KRN 1493
KRN-1493
LS-186593
Mimpara
Mimpara (TN)
MLS004774045
MLS006010213
N-((1R)-1-(1-Naphthyl)ethyl)-3-(3-(trifluoromethyl
N-((1R)-1-(naphthalen-1-yl)ethyl)-3-(3-(trifluoromethyl)phenyl)propan-1-amine hydrochloride
N-[(1R)-1-(1-naphthyl)ethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine hydrochloride
N-[(1R)-1-naphthalen-1-ylethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine hydrochloride
N-[(1R)-1-naphthalen-1-ylethyl]-3-[3-(trifluoromethyl)phenyl]propan-1-amine;hydrochloride
NCGC00181002-01
NCGC00181002-04
NPS-1493
Parareg
PubChem18298
Q27121179
QANQWUQOEJZMLL-PKLMIRHRSA-N
Regpara
S-7032
s1260
SB17366
SC-44773
Sensipar
Sensipar (TN)
SENSIPAR(TM)
SMR002530058
ST24020763
SW219246-1
Tox21_112654
Tox21_112654_1
UNII-1K860WSG25
X4697
Z1741977003
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
Watson Labs Teva CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 204377-003 Dec 27, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Piramal Hlthcare Uk CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210207-003 Aug 1, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs Teva CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 204377-002 Dec 27, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 206125-001 Mar 8, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Strides Pharma CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 209226-003 Apr 30, 2018 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 021688-003 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 021688-001 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 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
1203761 C01203761/01 Switzerland   Start Trial PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
1203761 05C0029 France   Start Trial PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
>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.