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Last Updated: January 18, 2020

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SENSIPAR Drug Profile

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Which patents cover Sensipar, and when can generic versions of Sensipar launch?

Sensipar is a drug marketed by Amgen and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-five patent family members in twenty-eight countries.

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

US ANDA Litigation and Generic Entry Outlook for Sensipar

  Start Trial

A generic version of SENSIPAR was approved as cinacalcet hydrochloride by AUROBINDO PHARMA LTD on January 18th, 2020.

Drug patent expirations by year for SENSIPAR
Drug Prices for SENSIPAR

See drug prices for SENSIPAR

Recent Clinical Trials for SENSIPAR

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

SponsorPhase
University of California, San FranciscoPhase 4
VA Office of Research and DevelopmentPhase 4
Peter VestergaardPhase 3

See all SENSIPAR clinical trials

Recent Litigation for SENSIPAR

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 SENSIPAR litigation

PTAB Litigation
PetitionerDate
Complex Innovations, LLC2015-10-26

See all SENSIPAR litigation

Pharmacology for SENSIPAR
Synonyms for SENSIPAR
(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)-
1K860WSG25
226256-56-0 (Parent)
364782-34-3
782C343
AB0031566
ABP000405
AC-1799
AC1L4G5U
AK-64582
AKOS005146514
AKOS015969126
AM90312
AMG 073
AMG 073 HCl
AMG-073 HCL
AMG-073 HCl (Cinacalcet hydrochloride)
AMG-073.HCl
AMG073 HCl
AN-255
API0006427
AX8213065
BC677648
BCP02533
BCP9000286
BCPP000409
BR-64582
C22H22F3N.HCl
CAS-364782-34-3
CC0163
CHEBI:48391
CHEMBL1200776
Cinacalcet (hydrochloride)
Cinacalcet HCl
Cinacalcet hydrochloride
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
I14-3273
J-520045
KB-210415
KB-48917
KRN 1493
KRN-1493
LS-186593
Mimpara
Mimpara (TN)
MLS004774045
MLS006010213
MolPort-006-393-290
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
QANQWUQOEJZMLL-PKLMIRHRSA-N
Regpara
RL03386
S-7032
s1260
SB17366
SC-44773
Sensipar (TN)
SENSIPAR(TM)
SMR002530058
ST24020763
SW219246-1
Tox21_112654
Tox21_112654_1
UNII-1K860WSG25
X4697
Z1741977003
Paragraph IV (Patent) Challenges for SENSIPAR
Tradename Dosage Ingredient NDA Submissiondate
SENSIPAR TABLET;ORAL cinacalcet hydrochloride 021688 2008-03-10

US Patents and Regulatory Information for SENSIPAR

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 021688-001 Mar 8, 2004 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 AB RX Yes No   Start Trial   Start Trial Y   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 SENSIPAR

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 021688-002 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
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 SENSIPAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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

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