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:

Johnson and Johnson
Baxter
Express Scripts
Colorcon
Merck
McKinsey

Last Updated: October 20, 2019

DrugPatentWatch Database Preview

LESCOL XL Drug Profile

See Plans and Pricing

« Back to Dashboard

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

Lescol Xl is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in nineteen countries.

The generic ingredient in LESCOL XL is fluvastatin sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluvastatin sodium profile page.

Drug patent expirations by year for LESCOL XL
Drug Prices for LESCOL XL

See drug prices for LESCOL XL

Recent Clinical Trials for LESCOL XL

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

SponsorPhase
University of California, San FranciscoPhase 4
University of BaselPhase 4
University of ZurichPhase 4

See all LESCOL XL clinical trials

Recent Litigation for LESCOL XL

Identify potential future generic entrants

District Court Litigation
Case NameDate
Kowa Company, Ltd. v. Sawai USA, Inc.2014-07-23
Novartis Pharmaceuticals Corporation v. Mylan Pharmaceuticals Inc.2011-02-11
AstraZeneca Pharmaceuticals LP v. Cobalt Pharmaceuticals Inc.2007-12-11

See all LESCOL XL litigation

Pharmacology for LESCOL XL
Synonyms for LESCOL XL
(-)-(3S,5R)-fluvastatin sodium
(-)-3s,5r-fluvastatin sodium salt
(-)-fluvastatin sodium
(?)-Fluvastatin
(+)-(3R,5S)-fluvastatin sodium
(+)-3R,5S-Fluvastatin sodium salt
(+)-fluvastatin sodium
(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxy hept-6-enoic acid sodium salt
(3R,5S,6E)-7-[3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoic acid sodium salt
(3R,5S,6E)-rel-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic Acid Sodium Salt
(3R,5S)-(+)-fluvastatin sodium
(3R,5S)-7-[3-(4-Fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl]-3,5-dihydroxy-6-heptenoic Acid Sodium Salt
(3r,5s)-fluvastatin sodium
(3R,5S)-Fluvastatin Sodium Salt
(3S,5R) Fluvastatin Sodium Salt
(3S,5R)-(-)-fluvastatin sodium
(3S,5R)-7-(3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl)-3,5-dihydroxyhept-6-enoic acid sodium salt
(3s,5r)-7-(3-(4-fluorophenyl)-1-isopropyl-1h-indol-2-yl)-3,5-dihydroxyhept-6-enoic acidsodium salt
(3S,5R)-fluvastatin sodium
(e)-(3r,5s)-(+)-7-[3-(4-fluoro-phenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxy-hept-6-enoic acid sodium salt
(e)-(3r,5s)-7-[3-(4-fluoro-phenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxy-hept-6-enoic acid sodium salt
(e)-(3r,5s)-7-[3-(4-fluoro-phenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxy-hept-6enoic acid sodium salt
155229-75-7
155229-76-8
6-Heptenoic acid, 7-(3-(4-fluorophenyl)-1-(1-methylethyl)-1H-indol-2-yl)-3,5-dihydroxy-, monosodium salt, (S-(R*,S*-(E)))-
93957-54-1
93957-55-2
93957-55-2 (hydrochloride salt)
93957-55-2 (Parent)
94061-80-0
94061-81-1
AB01274723-01
AB2000367
AC-6856
AK113368
AKOS015894901
AKOS016340657
AN-6324
API0002750
API0005677
AX8023193
C24H25FNNaO4
Canef
CAS-93957-55-2
CCG-220859
CHEBI:77602
CHEBI:77603
CHEMBL241778
CHEMBL333442
Cranoc
D00892
DSSTox_CID_24758
DSSTox_GSID_44758
DSSTox_RID_80451
DTXSID3044758
EBD33359
F0820
Fluindostatin
Fluindostatin sodium
fluvastatin
Fluvastatin (sodium)
Fluvastatin for system suitability, European Pharmacopoeia (EP) Reference Standard
FLUVASTATIN SODIUM
Fluvastatin sodium (JAN/USAN)
Fluvastatin sodium (Lescol)
Fluvastatin sodium [USAN:USP]
Fluvastatin sodium salt
Fluvastatin sodium, European Pharmacopoeia (EP) Reference Standard
Fluvastatin sodium, Pharmaceutical Secondary Standard; Certified Reference Material
Fluvastatin sodium, United States Pharmacopeia (USP) Reference Standard
Fluvastatin Sodium,(S)
Fluvastatin-d6 sodium salt
Fluyastatin Sodium Salt
Fractal
HMS1570L19
HMS2097L19
HMS2233N10
HMS3067L20
HMS3714L19
I06-043
Ir(ppy)3;
J-009181
J90003
KB-303031
KS-1062
Lescol
Lescol (TN)
Lipaxan
Lochol
Locol
Lymetel
MLS001165673
MLS001304715
MLS002154037
MLS006010060
MolPort-002-885-826
MolPort-006-709-421
NCGC00164604-01
NCGC00263525-01
Prestwick_1032
Primesin
s1909
SC-26268
SCHEMBL41502
SCHEMBL41503
SCHEMBL41663
SMR000550480
SMR000705060
sodium (3R,5S,6E)-7-[3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
sodium (3R,5S,6E)-7-[3-(4-fluorophenyl)-1-isopropylindol-2-yl]-3,5-dihydroxyhept-6-enoate
Sodium (3R,5S,E)-7-(3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl)-3,5-dihydroxyhept-6-enoate
sodium (3S,5R,6E)-7-[3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
sodium (3S,5R,E)-7-(3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl)-3,5-dihydroxyhept-6-enoate
sodium (E,3R,5S)-7-[3-(4-fluorophenyl)-1-isopropyl-indol-2-yl]-3,5-dihydroxy-hept-6-enoate
sodium (E,3S,5R)-7-[3-(4-fluorophenyl)-1-propan-2-ylindol-2-yl]-3,5-dihydroxyhept-6-enoate
Sodium (E)-(3R,5S)-7-[3-(4-fluoro-phenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxy-hept-6-enoate
sodium, (e)-(3s,5r)-7-[3-(4-fluoro-phenyl)-1-isopropyl-1h-indol-2-yl]-3,5-dihydroxy-hept-6-enoate
sodium;(E,3R,5S)-7-[3-(4-fluorophenyl)-1-propan-2-ylindol-2-yl]-3,5-dihydroxyhept-6-enoate
Sri 62320
Sri-62320
ST24047218
SW197104-2
Tox21_112226
Tox21_112226_1
UNII-PYF7O1FV7F component ZGGHKIMDNBDHJB-NRFPMOEYSA-M
UNII-PYF7O1FV7F component ZGGHKIMDNBDHJB-RPQBTBOMSA-M
Vastin
Xilep XL
XU 62-320
XU 62-320;Canef;Vastin;Lescol
XU-62-320
XU-620
ZGGHKIMDNBDHJB-NRFPMOEYSA-M

US Patents and Regulatory Information for LESCOL XL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000 AB RX Yes Yes   Start Trial   Start Trial Y   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 LESCOL XL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000   Start Trial   Start Trial
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 2000   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for LESCOL XL
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 80 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for LESCOL XL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0114027 96C0022 Belgium   Start Trial PRODUCT NAME: FLUVASTATINE SODIQUE; NAT. REGISTRATION NO/DATE: 151 IS 207 F 4 19960409; FIRST REGISTRATION: GB 0101/0360 19930823
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
McKinsey
Merck
Harvard Business School
Moodys

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.