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Generated: November 21, 2018

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Fluvastatin sodium - Generic Drug Details

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What are the generic drug sources for fluvastatin sodium and what is the scope of fluvastatin sodium freedom to operate?

Fluvastatin sodium is the generic ingredient in three branded drugs marketed by Mylan Pharms Inc, Teva Pharms, Novartis, and Teva Pharms Usa, and is included in six NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for fluvastatin sodium. Five suppliers are listed for this compound. There is one tentative approval for this compound.

Pharmacology for fluvastatin sodium
Synonyms for fluvastatin sodium
(-)-(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)-7-[3-(4-Fluoro-phenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxy-hept-6-enoic acid sodium 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)))-
93957-55-2
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
Bio-0125
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 (sodium)
Fluvastatin for system suitability, European Pharmacopoeia (EP) Reference Standard
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; traceable to USP and PhEur
Fluvastatin sodium, United States Pharmacopeia (USP) Reference Standard
Fluyastatin Sodium Salt
Fractal
HMS1570L19
HMS2097L19
HMS2233N10
HMS3067L20
I06-043
Ir(ppy)3;
J-009181
J90003
KB-303031
KS-1062
Lescol
Lescol (TN)
Lescol XL
Lipaxan
Lochol
Locol
LP123091
Lymetel
MFCD08063391
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 (3S,5R,6E)-7-[3-(4-fluorophenyl)-1-isopropyl-1H-indol-2-yl]-3,5-dihydroxyhept-6-enoate
SODIUM (3S,5R,6E)-7-[3-(4-FLUOROPHENYL)-1-ISOPROPYLINDOL-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
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
Tentative approvals for FLUVASTATIN SODIUM
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial80MGTABLET, EXTENDED RELEASE; ORAL

US Patents and Regulatory Information for fluvastatin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc FLUVASTATIN SODIUM fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 202458-001 Sep 11, 2015 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc FLUVASTATIN SODIUM fluvastatin sodium CAPSULE;ORAL 090595-001 Apr 11, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa FLUVASTATIN SODIUM fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 079011-001 Jan 27, 2016 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 fluvastatin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-001 Dec 31, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis LESCOL fluvastatin sodium CAPSULE;ORAL 020261-002 Dec 31, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis LESCOL XL fluvastatin sodium TABLET, EXTENDED RELEASE;ORAL 021192-001 Oct 6, 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 fluvastatin sodium

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0022 Belgium ➤ Try a Free Trial PRODUCT NAME: FLUVASTATINE SODIQUE; NAT. REGISTRATION NO/DATE: 151 IS 207 F 4 19960409; FIRST REGISTRATION: GB 0101/0360 19930823
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Julphar
Harvard Business School
Teva
Johnson and Johnson
Cipla
Chubb
Merck
Medtronic

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