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Last Updated: December 9, 2019

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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 patent protection?

Nateglinide is the generic ingredient in two branded drugs marketed by Alvogen, Cadila Pharms Ltd, Dr Reddys Labs Ltd, Par Pharm, Teva Pharms, Watson Labs, Wilshire Pharms Inc, Zydus Pharms, and Novartis, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for nateglinide. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for nateglinide

See drug prices for nateglinide

Recent Clinical Trials for nateglinide

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

SponsorPhase
Zhongda HospitalPhase 4
Drug Safety and Effectiveness Network, CanadaN/A
Novo Nordisk A/SPhase 4

See all nateglinide clinical trials

Generic filers with tentative approvals for NATEGLINIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial120MGTABLET;ORAL
  Start Trial  Start Trial60MGTABLET;ORAL

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

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-isopropylcyclohexane
(r)-2-((1r,4r)-4-isopropylcyclohexanecarboxamido)-3-phenylpropanoic acid
(trans-4-isopropylcyclohexane-1-carbonyl)-D-phenylalanine
105746-37-0
105816-04-4
105816-06-6
2-[(4-Isopropyl-cyclohexanecarbonyl)-amino]-3-phenyl-propionic 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
AKOS005577723
AKOS015841612
AKOS015960899
AKOS027446512
AY 4166
AY-4166
AY4166
BBL033469
BC204579
BCP28400
BDBM50344967
BIDD:GT0257
C12508
carboxamido)-3-phenylpropanoic acid
CAS-105816-04-4
CCG-100898
CHEBI:31897
CHEBI:94617
CHEMBL2114389
CHEMBL783
CPD000466372
CS-2528
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
DB00731
DJN 608
DJN-608
DSSTox_CID_20687
DSSTox_GSID_40687
DSSTox_RID_79543
DTXSID9040687
EBD10749
Fastic
FT-0631035
GTPL6833
HMS2051G20
HMS2089A10
HMS2235O08
HMS3715F12
HY-B0422
K-0514
KS-5143
MCULE-4748076858
MFCD00875706
MLS000759500
MLS001424043
MLS003915639
MLS006011429
MolPort-003-986-201
N-(4alpha-Isopropylcyclohexane-1alpha-yl)carbonyl-D-phenylalanine
N-(Trans-4-Isopropylcyclohexylcarbonyl)-D-Phenyl Alanine
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-{[trans-4-(propan-2-yl)cyclohexyl]carbonyl}-D-phenylalanine
N0912
nateglinida
Nateglinide (JP17/USAN/INN)
Nateglinide (Starlix)
Nateglinide [INN]
Nateglinide [USAN:USP:INN:BAN]
Nateglinide cis Impurity
Nateglinide, >=98% (HPLC), solid
Nateglinide, European Pharmacopoeia (EP) Reference Standard
Nateglinide, Starlix
Nateglinide, United States Pharmacopeia (USP) Reference Standard
nateglinidum
NC00148
NCGC00095121-01
NCGC00178741-03
NCGC00271534-02
NCGC00271534-03
OELFLUMRDSZNSF-BRWVUGGUSA-N
Q-201449
s2489
SAM001246721
SB17322
SCHEMBL13753829
SCHEMBL22088
SCHEMBL303827
SCHEMBL7880361
SCHEMBL9232138
SDZ DJN 608
SDZ-DJN 608
SDZ-DJN-608
senaglinide
SMR000466372
Starlix
Starsis
Starsis (TN)
STK647123
SW197528-2
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
Paragraph IV (Patent) Challenges for NATEGLINIDE
Tradename Dosage Ingredient NDA Submissiondate
STARLIX TABLET;ORAL nateglinide 021204 2004-12-22

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
Par Pharm NATEGLINIDE nateglinide TABLET;ORAL 077463-002 Sep 9, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms NATEGLINIDE nateglinide TABLET;ORAL 077467-002 Sep 9, 2009 DISCN No No   Start Trial   Start Trial   Start Trial
Dr Reddys Labs Ltd NATEGLINIDE nateglinide TABLET;ORAL 077461-002 Sep 9, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Alvogen NATEGLINIDE nateglinide TABLET;ORAL 205055-002 Dec 11, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Cadila Pharms Ltd NATEGLINIDE nateglinide TABLET;ORAL 206432-002 Apr 19, 2019 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

Expired US Patents for nateglinide

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

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Serving leading biopharmaceutical companies globally:

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