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Last Updated: October 21, 2019

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Pravastatin sodium - Generic Drug Details

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What are the generic sources for pravastatin sodium and what is the scope of patent protection?

Pravastatin sodium is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb, Accord Hlthcare, Apnar Pharma Lp, Apotex Inc, Aurobindo Pharma Ltd, Chartwell Rx, Cipla, Dr Reddys Labs Inc, Glenmark Generics, Hisun Pharm Hangzhou, Lupin Pharms, Mylan, Mylan Pharms Inc, Pliva Hrvatska Doo, Ranbaxy Labs Ltd, Teva, Teva Pharms, Watson Labs, and Zydus Pharms Usa, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

There are sixteen drug master file entries for pravastatin sodium. Forty-one suppliers are listed for this compound. There are two tentative approvals for this compound.

Drug Prices for pravastatin sodium

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Drug Sales Revenue Trends for pravastatin sodium

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Recent Clinical Trials for pravastatin sodium

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SponsorPhase
Dr. Robert F. CasperN/A
Yooyoung Pharmaceutical Co.,Ltd.Phase 3
Children's Mercy Hospital Kansas CityPhase 1

See all pravastatin sodium clinical trials

Recent Litigation for pravastatin sodium

Identify potential future generic entrants

District Court Litigation
Case NameDate
SUPERNUS PHARMACEUTICALS, INC. v. PAR PHARMACEUTICAL COMPANIES, INC.2015-01-16
AstraZeneca Pharmaceuticals LP v. Aurobindo Pharma Limited Inc.2008-06-24
AstraZeneca Pharmaceuticals LP v. Sun Pharmaceutical Industries Ltd.2007-12-11

See all pravastatin sodium litigation

Generic filers with tentative approvals for PRAVASTATIN SODIUM
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial80MGTABLET;ORAL
  Start Trial  Start Trial40MGTABLET;ORAL
  Start Trial  Start Trial20MGTABLET;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 pravastatin sodium
Medical Subject Heading (MeSH) Categories for pravastatin sodium
Synonyms for pravastatin sodium
(?R,?R,1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-Hexahydro-?,?,6-trihydroxy-2-methyl-8-[(2S)-2-methyl-1-oxobutoxy]-1-naphthaleneheptanoic acid monosodium salt
(|AR, |AR,1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-Hexahydro-|A, |A,6-trihydroxy-2-methyl-8[(2S)-2-methyl-1-oxobutoxyl]-1-naphthaleneheptanoic acid sodium hydrate
(|AR,|AR,1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-Hexahydro-|A,|A,6-trihydroxy-2-methyl-8-[(2S)-2-methyl-1-oxobutoxy]-1-naphthaleneheptanoic Acid Sodium Salt
(betaR,deltaR,1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-Hexahydro-beta,delta,6-trihydroxy-2-methyl-8[(2S)-2-methyl-1-oxobutoxyl]-1-naphthaleneheptanoic Acid Na
1-Naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-2-methyl-8-(2-methyl-1-oxobutoxy)-beta,delta,6-trihydroxy-, monosodium salt, (1S-(1-alpha(beta-S*,delta-S*),2-alpha,6-alpha,8-beta(R*),8a-alpha))-
1-Naphthaleneheptanoic acid, 1,2,6,7,8,8a-hexahydro-beta,delta,6-trihydroxy-2-methyl-8-(2-methyl-1-oxobutoxy)-, monosodium salt, (1S-(1alpha(betaS*,deltaS*),2alpha,6alpha,8beta(R*),8aalpha))-
115873-26-2
2-methyl-8-((S)-2-methylbutanoyloxy)-1,2,6,7,8,8a-
3-beta-Hydroxycompactin sodium salt
3beta-Hydroxycompactin, Na
3M8608UQ61
81093-37-0 (Parent)
81131-70-6
81131-73-9
85956-24-7
87098-76-8
AK150793
AKOS015896504
AKOS015964902
Aplactin
Bristacol
C-22432
C23H35O7.Na
CAS-81131-70-6
CC-33901
CCG-100926
CHEBI:8361
CHEMBL690
CPD000469187
CRES Pravastatin
CS-2003
CS-514
D00893
DRG-0319
DSSTox_CID_27525
DSSTox_GSID_47525
DSSTox_RID_82395
DTXSID6047525
Elisor
Epastatin sodium
Eptastatin sodium
Eptastatin sodium salt hydrate
hexahydronaphthalen-1-yl)heptanoate
HMS2051P05
HMS3268L20
HY-B0165A
I06-2463
Kopostat
Lipemol
Lipidal
Liplat
Lipostat
Liprevil
LS-94711
Mevalotin
MolPort-003-849-962
NC00176
NCGC00092370-01
NCGC00095183-01
NCGC00254232-01
P1796
Pralidon
Prareduct
Pravachol
Pravachol (TN)
Pravacol
Pravaselect
Pravasin
Pravasine
Pravastatin (sodium)
Pravastatin Natrium Mayrho Fer
Pravastatin sodium (JP17/USAN)
Pravastatin sodium [USAN:JAN]
Pravastatin sodium [USAN:USP:JAN]
Pravastatin Sodium Salt
Pravastatin sodium salt hydrate
Pravastatin sodium salt hydrate, >=98% (HPLC), powder
Pravastatin, Sodium Salt
Pravastatinsodium,(S)
PubChem21972
s3036
SAM001246656
Sanaprav
SC-46788
SCHEMBL3013
Selektine
Selipran
Sodium (+)-(betaR,deltaR,1S,2S,6S,8S,8aR)-1,2,6,7,8,8a-hexahydro-beta,delta,6,8-tetrahydroxy-2-methyl-1-naphthaleneheptanoate, 8-((2S)-2-methylbutyrate)
sodium (3R,5R)-3,5-dihydroxy-7-((1S,2S,6S,8S,8aR)-6-hydroxy-
sodium (3R,5R)-3,5-dihydroxy-7-((1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-((S)-2-methylbutanoyloxy)-1,2,6,7,8,8a-hexahydronaphthalen-1-yl)heptanoate
sodium (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-{[(2S)-2-methylbutanoyl]oxy}-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]heptanoate
sodium;(3R,5R)-7-[(1S,2S,6S,8S,8aR)-6-hydroxy-2-methyl-8-[(2S)-2-methylbutanoyl]oxy-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoate
SQ 31000
SQ-31,000
SQ-31000
ST2407537
Tox21_111474
Tox21_300270
UNII-3M8608UQ61
Vasen
Vasten
VWBQYTRBTXKKOG-IYNICTALSA-M

US Patents and Regulatory Information for pravastatin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-004 Mar 22, 1993 AB RX Yes No   Start Trial   Start Trial   Start Trial
Mylan PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077013-002 Oct 23, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb PRAVACHOL pravastatin sodium TABLET;ORAL 019898-003 Oct 31, 1991 AB RX Yes No   Start Trial   Start Trial   Start Trial
Teva PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 076056-001 Apr 24, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077904-001 Oct 23, 2006 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 203367-001 Feb 2, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Hisun Pharm Hangzhou PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 206061-003 Nov 23, 2018 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 pravastatin sodium

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Moodys

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