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Generated: September 19, 2019

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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 freedom to operate?

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 fifty-one patent family members in twenty-seven countries.

There are twenty-four drug master file entries for cinacalcet hydrochloride. Twelve 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
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 (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
Sensipar (TN)
SENSIPAR(TM)
SMR002530058
ST24020763
SW219246-1
Tox21_112654
Tox21_112654_1
UNII-1K860WSG25
X4697
Z1741977003
Generic filers with tentative approvals for CINACALCET HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up30MGTABLET; ORAL
➤ Sign Up➤ Sign Up90MGTABLET; ORAL
➤ Sign Up➤ Sign Up60MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lupin Ltd CINACALCET HYDROCHLORIDE cinacalcet hydrochloride TABLET;ORAL 210548-002 Jun 28, 2019 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-003 Mar 8, 2004 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
>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 ➤ Sign Up ➤ Sign Up
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-001 Mar 8, 2004 ➤ Sign Up ➤ Sign Up
Amgen SENSIPAR cinacalcet hydrochloride TABLET;ORAL 021688-002 Mar 8, 2004 ➤ Sign Up ➤ Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Supplementary Protection Certificates for cinacalcet hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1203761 05C0029 France ➤ Sign Up PRODUCT NAME: CINACALCET; REGISTRATION NO/DATE: EU/01/04/292/001-012 20041022
1203761 SPC/GB05/031 United Kingdom ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: CINACALCETUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56965 27.10.2004
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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