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Last Updated: April 6, 2020

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CINACALCET HYDROCHLORIDE Drug Profile


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When do Cinacalcet Hydrochloride patents expire, and when can generic versions of Cinacalcet Hydrochloride launch?

Cinacalcet Hydrochloride is a drug marketed by Alkem Labs Ltd, Aurobindo Pharma Ltd, Cipla, Lupin Ltd, Mylan, Piramal Hlthcare Uk, Strides Pharma, Sun Pharm, and Watson Labs Teva. and is included in nine NDAs.

The generic ingredient in CINACALCET HYDROCHLORIDE is cinacalcet hydrochloride. There are twenty-four drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the cinacalcet hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Cinacalcet Hydrochloride

A generic version of CINACALCET HYDROCHLORIDE was approved as cinacalcet hydrochloride by AUROBINDO PHARMA LTD on March 8th, 2018.

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Drug patent expirations by year for CINACALCET HYDROCHLORIDE
Recent Clinical Trials for CINACALCET HYDROCHLORIDE

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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

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

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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
Alkem Labs Ltd CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210570-001 May 17, 2019 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
Sun Pharm CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 207008-003 Oct 11, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 208915-001 Mar 8, 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Johnson and Johnson
Moodys
McKinsey
Baxter
Mallinckrodt

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