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:

Medtronic
Johnson and Johnson
McKinsey
AstraZeneca
Baxter
Harvard Business School

Last Updated: December 12, 2019

DrugPatentWatch Database Preview

PRAVASTATIN SODIUM 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

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

Pravastatin Sodium is a drug marketed by 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 nineteen NDAs.

The generic ingredient in PRAVASTATIN SODIUM is pravastatin sodium. There are sixteen drug master file entries for this compound. Forty-one suppliers are listed for this compound. Additional details are available on the pravastatin sodium profile page.

US ANDA Litigation and Generic Entry Outlook for Pravastatin Sodium

A generic version of PRAVASTATIN SODIUM was launched as pravastatin sodium by TEVA on December 12th, 2019.

Drug patent expirations by year for PRAVASTATIN SODIUM
Drug Prices for PRAVASTATIN SODIUM

See drug prices for PRAVASTATIN SODIUM

Drug Sales Revenue Trends for PRAVASTATIN SODIUM

See drug sales revenues for PRAVASTATIN SODIUM

Recent Clinical Trials for PRAVASTATIN SODIUM

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

SponsorPhase
Dr. Robert F. CasperN/A
Yooyoung Pharmaceutical Co.,Ltd.Phase 3
American Heart AssociationPhase 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

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
Paragraph IV (Patent) Challenges for PRAVASTATIN SODIUM
Tradename Dosage Ingredient NDA Submissiondate
PRAVACHOL TABLET;ORAL pravastatin sodium 019898 2005-06-01

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
Mylan PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077013-002 Oct 23, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
Glenmark Generics PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077987-004 Dec 28, 2007 AB RX No No   Start Trial   Start Trial   Start Trial
Pliva Hrvatska Doo PRAVASTATIN SODIUM pravastatin sodium TABLET;ORAL 077730-002 Nov 21, 2006 DISCN 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

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

Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
Mallinckrodt
Baxter
Harvard Business School
Johnson and Johnson

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.