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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Chinese Patent Office
Boehringer Ingelheim
Harvard Business School
Medtronic
UBS
Federal Trade Commission
Cantor Fitzgerald
Daiichi Sankyo

Generated: June 22, 2018

DrugPatentWatch Database Preview

STARLIX Drug Profile

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When do Starlix patents expire, and what generic alternatives are available?

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

This drug has forty-two patent family members in thirty countries.

The generic ingredient in STARLIX is nateglinide. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the nateglinide profile page.
Summary for STARLIX
Drug patent expirations by year for STARLIX
Pharmacology for STARLIX
Drug ClassGlinide
Mechanism of ActionPotassium Channel Antagonists
Synonyms for STARLIX
(-)-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
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 (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

US Patents and Regulatory Information for STARLIX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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
Novartis STARLIX nateglinide TABLET;ORAL 021204-001 Dec 22, 2000 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ 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
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 STARLIX

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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Paragraph IV (Patent) Challenges for STARLIX
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 60 mg and 120 mg ➤ Subscribe 2004-12-22

Premature patent expiration for: STARLIX

Expiration due to failure to pay maintenance fee

Patent Number Tradename Expiration Date
➤ Try a Free Trial STARLIX ➤ Try a Free Trial
➤ Try a Free Trial STARLIX ➤ Try a Free Trial

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Supplementary Protection Certificates for STARLIX

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:

Deloitte
Argus Health
Queensland Health
Healthtrust
Farmers Insurance
Johnson and Johnson
US Army
Cerilliant
US Department of Justice

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