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PRAVASTATIN SODIUM Drug Profile
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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.
Summary for PRAVASTATIN SODIUM
See drug prices for PRAVASTATIN SODIUM
Recent Clinical Trials for PRAVASTATIN SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Dr. Robert F. Casper | N/A |
| Yooyoung Pharmaceutical Co.,Ltd. | Phase 3 |
| American Heart Association | Phase 1 |
Recent Litigation for PRAVASTATIN SODIUM
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| 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 |
Pharmacology for PRAVASTATIN SODIUM
| Drug Class | HMG-CoA Reductase Inhibitor |
| Mechanism of Action | Hydroxymethylglutaryl-CoA Reductase Inhibitors |
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 |
