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Generated: October 16, 2018

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Cinacalcet hydrochloride - Generic Drug Details

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What are the generic sources for cinacalcet hydrochloride and what is the scope of cinacalcet hydrochloride patent protection?

Cinacalcet hydrochloride is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Cipla Ltd, Piramal Hlthcare Uk, Strides Pharma, Zydus Pharms Usa Inc, and Amgen, and is included in six NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

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)-
1K860WSG25
226256-56-0 (Parent)
364782-34-3
782C343
AB0031566
ABP000405
AC-1799
AC1L4G5U
AK-64582
AKOS005146514
AKOS015969126
AM90312
AMG 073 HCl
AMG-073 HCL
AMG-073 HCl (Cinacalcet hydrochloride)
AMG-073.HCl
AMG073 HCl
AN-255
API0006427
AX8213065
BC677648
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/
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
MFCD08067750
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
OR244319
Parareg
PubChem18298
QANQWUQOEJZMLL-PKLMIRHRSA-N
Regpara
RL03386
S-7032
s1260
SC-44773
Sensipar
Sensipar (TN)
SENSIPAR(TM)
SMR002530058
ST24020763
ST51054898
Tox21_112654
Tox21_112654_1
UNII-1K860WSG25
X4697
Z1741977003
Tentative approvals for CINACALCET HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial90MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial60MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial30MGTABLET; ORAL

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Zydus Pharms Usa Inc CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 208971-001 Apr 23, 2018 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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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Expired US Patents for cinacalcet hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for cinacalcet hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C020/2005 Ireland ➤ Try a Free Trial SPC020/2005: 20060407, EXPIRES: 20191021
2005 00027 Denmark ➤ Try a Free Trial
182 Luxembourg ➤ Try a Free Trial 91182, EXPIRES: 20191022
C/GB05/031 United Kingdom ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
UBS
Accenture
Queensland Health
Covington
Harvard Business School
Argus Health
Deloitte
AstraZeneca

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