Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Baxter
Moodys
McKesson
Johnson and Johnson

Last Updated: December 16, 2019

DrugPatentWatch Database Preview

STARLIX Drug Profile

Join the DrugPatentWatch Referral Program
Get access to a free drug patent landscape report or a free one-month subscription

« Back to Dashboard

Which patents cover Starlix, and when can generic versions of Starlix launch?

Starlix is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in STARLIX is nateglinide. There are nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the nateglinide profile page.

US ANDA Litigation and Generic Entry Outlook for Starlix

A generic version of STARLIX was launched as nateglinide by DR REDDYS LABS LTD on December 16th, 2019.

Drug patent expirations by year for STARLIX
Drug Prices for STARLIX

See drug prices for STARLIX

Recent Clinical Trials for STARLIX

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

SponsorPhase
Novartis PharmaceuticalsPhase 4
Dr. Reddy's Laboratories LimitedPhase 1

See all STARLIX clinical trials

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-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
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
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 STARLIX
Tradename Dosage Ingredient NDA Submissiondate
STARLIX TABLET;ORAL nateglinide 021204 2004-12-22

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 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novartis STARLIX nateglinide TABLET;ORAL 021204-002 Dec 22, 2000 DISCN Yes 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 STARLIX

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 021204-001 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 021204-001 Dec 22, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
Johnson and Johnson
Merck
Baxter
McKesson
AstraZeneca

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.