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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Covington
Teva
UBS
Accenture
Cantor Fitzgerald
Moodys
Citi
Boehringer Ingelheim

Generated: June 22, 2018

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Nateglinide - Generic Drug Details

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What are the generic sources for nateglinide and what is the scope of nateglinide freedom to operate?

Nateglinide
is the generic ingredient in two branded drugs marketed by Alvogen Malta, Dr Reddys Labs Ltd, Par Pharm, Teva Pharms, Watson Labs, Zydus Pharms Usa Inc, and Novartis, and is included in seven NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Nateglinide has forty-two patent family members in thirty countries.

There are nine drug master file entries for nateglinide. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for nateglinide
Pharmacology for nateglinide
Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists
Synonyms for nateglinide
(-)-N-(trans-4-Isopropylcyclohexanecarbonyl)-D-phenylalanine
((1r,4R)-4-isopropylcyclohexane-1-carbonyl)-D-phenylalanine
(2R)-2-[(4-isopropylcyclohexanecarbonyl)amino]-3-phenyl-propanoic acid
(2R)-2-[[oxo-(4-propan-2-ylcyclohexyl)methyl]amino]-3-phenylpropanoic acid
(2R)-3-phenyl-2-[(4-propan-2-ylcyclohexanecarbonyl)amino]propanoic acid
(2R)-3-phenyl-2-[(4-propan-2-ylcyclohexyl)carbonylamino]propanoic acid
(2R)-3-phenyl-2-{[(1r,4r)-4-(propan-2-yl)cyclohexyl]formamido}propanoic acid
(r)-2-((1r,4r)-4-isopropylcyclohexanecarboxamido)-3-phenylpropanoic acid
(R)-2-(cis-4-Isopropylcyclohexanecarboxamido)-3-phenylpropanoic acid
(trans-4-isopropylcyclohexane-1-carbonyl)-D-phenylalanine
105816-04-4
105816-06-6
2-[(4-Isopropyl-cyclohexanecarbonyl)-amino]-3-phenyl-propionic acid
3-phenyl-2-[(4-propan-2-ylcyclohexanecarbonyl)amino]propanoic acid
41X3PWK4O2
816N044
A 4166
A-4166
A-4166;
A1-02996
A801324
AB0011153
AB00639979_12
AB00639979-06
AB00639979-08
AB00639979-09
AB00639979-11
AB2000594
AC-1690
AC1NSKEK
AK516439
AKOS005577723
AKOS015841612
AKOS015960899
AKOS027446512
AY 4166
AY-4166
AY4166
BBL033469
BC204579
BDBM50344967
BIDD:GT0257
Bio-0067
C12508
CAS-105816-04-4
CCG-100898
CHEBI:31897
CHEBI:94617
CHEMBL2114389
CHEMBL783
CPD000466372
CS-2528
D-Nateglinide
D-Phenylalanine, N-((4-(1-methylethyl)cyclohexyl)carbonyl)-, trans-
D-phenylalanine, N-((trans-4-(1-methylethyl)cyclohexyl)carbonyl)-
D-Phenylalanine, N-[[trans-4-(1-methylethyl)cyclohexyl]carbonyl]-
D01111
D06PSS
DB00731
DJN 608
DJN-608
DSSTox_CID_20687
DSSTox_GSID_40687
DSSTox_RID_79543
DTXSID9040687
EBD10749
Fastic
FT-0631035
glinate
glunate
GTPL6833
HMS2051G20
HMS2089A10
HMS2235O08
HY-B0422
IPCCPA
K-0514
KS-5143
MCULE-4748076858
MFCD00875706
MLS000759500
MLS001424043
MLS003915639
MLS006011429
MolPort-003-986-201
N-((4-isopropylcyclohexyl)carbonyl)phenylalanine
N-(4alpha-Isopropylcyclohexane-1alpha-yl)carbonyl-D-phenylalanine
n-(trans-4-isopropylcyclohexylcarbonyl)-d-phenylalanine
N-[(trans-4-isopropylcyclohexyl)-carbonyl]-D-phenylalanine
N-[(trans-4-Isopropylcyclohexyl)carbonyl]-D-phenylalanine
N-[[4-(1-methylethyl)cyclohexyl]carbonyl]-D-phenylalanine
N-[[cis-4-(1-Methylethyl)cyclohexyl]carbonyl]-D-phenylalanine (Nateglinide Impurity)
n-[[trans-4-(1-methylethyl)cyclohexyl]carbonyl]-d-phenylalanine
n-{[4-(propan-2-yl)cyclohexyl]carbonyl}phenylalanine
N-{[trans-4-(propan-2-yl)cyclohexyl]carbonyl}-D-phenylalanine
N0912
nate-glinide
nateglinida
Nateglinide (JP17/USAN/INN)
Nateglinide (Starlix)
Nateglinide [INN]
Nateglinide [USAN:USP:INN:BAN]
Nateglinide cis Impurity
Nateglinide Related CoMpound C
nateglinide, (cis,D-Phe)-isomer
nateglinide, (D-Phe)-isomer
Nateglinide, >=98% (HPLC), solid
Nateglinide, European Pharmacopoeia (EP) Reference Standard
Nateglinide, Starlix
Nateglinide, United States Pharmacopeia (USP) Reference Standard
nateglinidum
natelide
NC00148
NCGC00095121-01
NCGC00178741-03
NCGC00271534-03
Novartis brand of nateglinide
OELFLUMRDSZNSF-BRWVUGGUSA-N
Q-201449
s2489
SAM001246721
SCHEMBL13753829
SCHEMBL22088
SCHEMBL303827
SCHEMBL7880361
SCHEMBL9232138
SDZ DJN 608
SDZ-DJN 608
SDZ-DJN-608
senaglinide
SMR000466372
Starlix
Starlix (TN)
Starsis
Starsis (TN)
STK647123
TL8000218
Tox21_111432
Tox21_111432_1
trans-N-((4-(1-Methylethyl)cyclohexyl)carbonyl)-D-phenylalanine
trans-N-{[4-(1-methylethyl)cyclohexyl]carbonyl}-D-phenylalanine
Trazec
UNII-41X3PWK4O2
YM-026
ZINC100015346
ZINC101489663
ZINC9689
Tentative approvals for NATEGLINIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial60MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial120MGTABLET;ORAL

US Patents and Regulatory Information for nateglinide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Watson Labs NATEGLINIDE nateglinide TABLET;ORAL 077462-002 Mar 30, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Teva Pharms NATEGLINIDE nateglinide TABLET;ORAL 077467-002 Sep 9, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Ltd NATEGLINIDE nateglinide TABLET;ORAL 077461-001 Sep 9, 2009 AB RX No No ➤ 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 nateglinide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 ➤ 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 nateglinide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2001 Austria ➤ Try a Free Trial PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 - EU/1/01/174/021 20010403; FIRST REGISTRATION: LI 55401.01 - 02 20000928
C/GB01/045 United Kingdom ➤ Try a Free Trial PRODUCT NAME: NATEGLINIDE OR SALTS THEREOF; REGISTERED: CH 55401 20000928; CH 55402 20000928; UK EU/1/01/174/001 20010403; UK EU/1/01/174/002 20010403; UK EU/1/01/174/003 20010403; UK EU/1/01/174/004 20010403; UK EU/1/01/174/005 20010403; UK EU/1/01/174/006 20010403; UK EU/1/01/174/019 20010403; UK EU/1/01/174/020 20010403; UK EU/1/01/174/021 20010403; UK EU/1/01/174/013 20010403; UK EU/1/01/174/014 20010403; UK EU/1/01/174/015 20010403; UK EU/1/01/174/016 20010403; UK EU/1/01/174/017 20010403; UK EU/1/01/174/018 20010403; UK EU/1/01/174/007 20010403; UK EU/1/01/174/008 20010403; UK EU/1/01/174/009 20010403; UK EU/1/01/174/010 20010403; UK EU/1/01/174/011 20010403; UK EU/1/01/174/012 2001040
C0044 France ➤ Try a Free Trial PRODUCT NAME: NATEGLINIDE; NAT. REGISTRATION NO/DATE: EU/1/01/174/001 20010403; FIRST REGISTRATION: LI - 55401 20000928
C/GB01/047 United Kingdom ➤ Try a Free Trial PRODUCT NAME: NATEGLINIDE; REGISTERED: CH 55401 01 20000928; CH 55401 02 20000928; UK EU/1/01/174/001 20010403; UK EU/1/01/174/002 20010403; UK EU/1/01/174/003 20010403; UK EU/1/01/174/004 20010403; UK EU/1/01/174/005 20010403; UK EU/1/01/174/006 20010403; UK EU/1/01/174/007 20010403; UK EU/1/01/174/008 20010403; UK EU/1/01/174/009 20010403; UK EU/1/01/174/010 20010403; UK EU/1/01/174/011 20010403; UK EU/1/01/174/012 20010403; UK EU/1/01/174/013 20010403; UK EU/1/01/174/014 20010403; UK EU/1/01/174/015 20010403; UK EU/1/01/174/016 20010403; UK EU/1/01/174/017 20010403; UK EU/1/01/174/018 20010403; UK EU/1/01/174/019 20010403; UK EU/1/01/174/020 20010403; UK EU/1/01/174/021 20010403
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Mallinckrodt
Cipla
Citi
Federal Trade Commission
QuintilesIMS
AstraZeneca
Medtronic
McKinsey

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