EP1330245A4 - Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same - Google Patents

Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same

Info

Publication number
EP1330245A4
EP1330245A4 EP01979511A EP01979511A EP1330245A4 EP 1330245 A4 EP1330245 A4 EP 1330245A4 EP 01979511 A EP01979511 A EP 01979511A EP 01979511 A EP01979511 A EP 01979511A EP 1330245 A4 EP1330245 A4 EP 1330245A4
Authority
EP
European Patent Office
Prior art keywords
pravastatin
epi
substantially free
compositions containing
lactone
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP01979511A
Other languages
German (de)
French (fr)
Other versions
EP1330245A1 (en
Inventor
Vilmos Keri
Lajos Deak
Ilona Forgacs
Csaba Szabo
Arvai Edit Nagyne
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Teva Pharmaceutical Works PLC
Original Assignee
Biogal Gyogyszergyar Rt
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=22897222&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP1330245(A4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Biogal Gyogyszergyar Rt filed Critical Biogal Gyogyszergyar Rt
Publication of EP1330245A1 publication Critical patent/EP1330245A1/en
Publication of EP1330245A4 publication Critical patent/EP1330245A4/en
Withdrawn legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
    • C07F1/00—Compounds containing elements of Groups 1 or 11 of the Periodic System
    • C07F1/04—Sodium compounds
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D309/00—Heterocyclic compounds containing six-membered rings having one oxygen atom as the only ring hetero atom, not condensed with other rings
    • C07D309/34—Heterocyclic compounds containing six-membered rings having one oxygen atom as the only ring hetero atom, not condensed with other rings having three or more double bonds between ring members or between ring members and non-ring members
    • C07D309/36—Heterocyclic compounds containing six-membered rings having one oxygen atom as the only ring hetero atom, not condensed with other rings having three or more double bonds between ring members or between ring members and non-ring members with oxygen atoms directly attached to ring carbon atoms
    • C07D309/38—Heterocyclic compounds containing six-membered rings having one oxygen atom as the only ring hetero atom, not condensed with other rings having three or more double bonds between ring members or between ring members and non-ring members with oxygen atoms directly attached to ring carbon atoms one oxygen atom in position 2 or 4, e.g. pyrones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
    • A61K31/215—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids
    • A61K31/22—Esters, e.g. nitroglycerine, selenocyanates of carboxylic acids of acyclic acids, e.g. pravastatin
    • A61K31/225—Polycarboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/365—Lactones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
    • C07C67/00—Preparation of carboxylic acid esters
    • C07C67/48—Separation; Purification; Stabilisation; Use of additives
    • C07C67/52—Separation; Purification; Stabilisation; Use of additives by change in the physical state, e.g. crystallisation
EP01979511A 2000-10-05 2001-10-05 Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same Withdrawn EP1330245A4 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US23827800P 2000-10-05 2000-10-05
US238278P 2000-10-05
PCT/US2001/031230 WO2002030415A1 (en) 2000-10-05 2001-10-05 Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same

Publications (2)

Publication Number Publication Date
EP1330245A1 EP1330245A1 (en) 2003-07-30
EP1330245A4 true EP1330245A4 (en) 2004-10-20

Family

ID=22897222

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01979511A Withdrawn EP1330245A4 (en) 2000-10-05 2001-10-05 Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same

Country Status (18)

Country Link
EP (1) EP1330245A4 (en)
JP (6) JP3737801B2 (en)
KR (1) KR20030059173A (en)
CN (1) CN1468098A (en)
AU (1) AU2002211462A1 (en)
CA (1) CA2422744A1 (en)
CZ (1) CZ20031166A3 (en)
HR (1) HRP20030347A2 (en)
HU (1) HUP0400913A2 (en)
IL (1) IL155194A0 (en)
IS (1) IS6766A (en)
MX (1) MXPA03002963A (en)
NO (1) NO20031532D0 (en)
NZ (1) NZ525631A (en)
PL (1) PL361230A1 (en)
SK (1) SK5232003A3 (en)
WO (1) WO2002030415A1 (en)
ZA (1) ZA200302313B (en)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1798214A3 (en) * 1999-11-30 2007-08-01 Teva Gyogyszergyár Zártköruen Muködo Részvenytarsaság Process for recovering statin compounds from a fermentation broth
EP1481674B1 (en) * 1999-11-30 2008-01-02 TEVA Gyógyszergyár Zártkörüen Müködö Részvénytársaság Process for recovering statin compounds from a fermentation broth
MXPA02005283A (en) * 1999-11-30 2003-10-06 Biogal Gyogyszergyar Process for recovering statin compounds from a fermentation broth.
PL364929A1 (en) 1999-12-14 2004-12-27 Biogal Gyogyszergyar Rt. Novel forms of pravastatin sodium
CZ20031166A3 (en) * 2000-10-05 2004-04-14 Biogal Gyogyszergyar Rt Pravastatin sodium salt that is substantially free of pravastatin lactone and epi-pravastatin as well as composition based thereon
JP3236282B1 (en) * 2000-10-16 2001-12-10 三共株式会社 How to purify pravastatin
GB0218781D0 (en) 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
EP1452519A1 (en) * 2003-02-25 2004-09-01 Balkanpharma-Razgrad AD Method for the isolation and purification of pravastatin sodium
GB0312896D0 (en) 2003-06-05 2003-07-09 Astrazeneca Ab Chemical process
UY28501A1 (en) 2003-09-10 2005-04-29 Astrazeneca Uk Ltd CHEMICAL COMPOUNDS
GB0324791D0 (en) 2003-10-24 2003-11-26 Astrazeneca Ab Chemical process
US7425644B2 (en) * 2003-11-24 2008-09-16 TEVA Gyógyszergyár Zártkörűen Működő Részvénytársaság Method of purifying pravastatin
NZ552389A (en) 2004-08-06 2009-05-31 Transform Pharmaceuticals Inc Statin pharmaceutical compositions and related methods of treatment
ES2254028B1 (en) * 2004-11-29 2007-03-01 Ercros Industrial, S.A. PROCEDURE FOR OBTAINING PRAVASTATIN SODIUM PURIFIED.
EP1851223A1 (en) * 2005-02-25 2007-11-07 Teva Pharmaceutical Industries Ltd Process of purifying tadalafil
JP4813841B2 (en) * 2005-07-25 2011-11-09 キユーピー株式会社 Method for producing pravastatin sodium
HU229260B1 (en) * 2010-11-29 2013-10-28 Egis Gyogyszergyar Nyrt Process for preparation of rosuvastatin salts
CN114031496A (en) * 2021-11-30 2022-02-11 广东蓝宝制药有限公司 Preparation method of high-purity pravastatin 1,1,3, 3-tetramethylbutylamine

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000046175A1 (en) * 1999-02-03 2000-08-10 Institute For Drug Research Ltd. Microbial process for preparing pravastatin
WO2001039768A1 (en) * 1999-11-30 2001-06-07 Biogal Gyogyszergyar Rt Process for recovering statin compounds from a fermentation broth

Family Cites Families (23)

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US3378441A (en) * 1963-10-17 1968-04-16 S B Penick & Company Tetraene antibiotic purification
JPS5221594B2 (en) * 1973-09-29 1977-06-11
JPS51101994A (en) * 1975-02-07 1976-09-08 Glaxo Lab Ltd
US4231938A (en) * 1979-06-15 1980-11-04 Merck & Co., Inc. Hypocholesteremic fermentation products and process of preparation
MX7065E (en) * 1980-06-06 1987-04-10 Sankyo Co A MICROBIOLOGICAL PROCEDURE FOR PREPARING DERIVATIVES OF ML-236B
JPS572240A (en) * 1980-06-06 1982-01-07 Sankyo Co Ltd Ml-236b derivative
JPS5889191A (en) * 1981-11-20 1983-05-27 Sankyo Co Ltd Preparation of 3-hydroxy-ml-236b derivative
JPS5890509A (en) * 1981-11-25 1983-05-30 Sankyo Co Ltd Composition for remedy of hypercholesterolemia
JPH01190661A (en) * 1988-01-22 1989-07-31 Konishi Kagaku Kogyo Kk Purification of 4,4'-dihydroxydiphenylsulfone
JP2739328B2 (en) * 1988-09-14 1998-04-15 日本ケミファ株式会社 Purification method of benzimidazole compound
US5202029A (en) * 1991-03-13 1993-04-13 Caron Kabushiki Kaisha Process for purification of hmg-coa reductase inhibitors
NZ250609A (en) * 1992-12-28 1995-07-26 Sankyo Co Hexahydronaphthalene esters and ring closed lactones; preparation and medicaments
JPH06256278A (en) * 1993-03-03 1994-09-13 Nissan Chem Ind Ltd Optically active alpha-carbamoylalkanoic acid derivative and its production
CA2126365C (en) * 1993-07-06 1999-08-24 Steven W. Felman Recovery of citric acid from impure process streams by addition of strong acids and salts thereof
MX9604372A (en) * 1994-03-31 1997-06-28 Pfizer Process for natamycin recovery.
ES2145479T3 (en) * 1995-08-03 2000-07-01 Dsm Nv IMPROVED PROCEDURE FOR OBTAINING LOVASTATIN, COMPACTINE OR PRAVASTATIN.
JPH09124655A (en) * 1995-11-01 1997-05-13 Sankyo Co Ltd New squalene synthase inhibition-active compound
EP0877089A1 (en) * 1997-05-07 1998-11-11 Gist-Brocades B.V. HMG-CoA reductase inhibitor preparation process
SI20070A (en) * 1998-09-18 2000-04-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. NOVEL SALTS OF INHIBITORS OF HMG-CoA REDUCTASE
SI20072A (en) * 1998-09-18 2000-04-30 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. PROCEDURE OF PREPARATION OF INHIBITORS OF HMG-CoA REDUCTASE
JP2000229855A (en) * 1998-12-07 2000-08-22 Satoshi Takebe Pravastatin sodium tablet
HUP9902352A1 (en) * 1999-07-12 2000-09-28 Gyógyszerkutató Intézet Kft. Process for producing pravastatin by microbiological way
CZ20031166A3 (en) * 2000-10-05 2004-04-14 Biogal Gyogyszergyar Rt Pravastatin sodium salt that is substantially free of pravastatin lactone and epi-pravastatin as well as composition based thereon

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000046175A1 (en) * 1999-02-03 2000-08-10 Institute For Drug Research Ltd. Microbial process for preparing pravastatin
WO2001039768A1 (en) * 1999-11-30 2001-06-07 Biogal Gyogyszergyar Rt Process for recovering statin compounds from a fermentation broth

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO0230415A1 *

Also Published As

Publication number Publication date
ZA200302313B (en) 2004-03-25
CN1468098A (en) 2004-01-14
NZ525631A (en) 2005-05-27
JP3737801B2 (en) 2006-01-25
WO2002030415A9 (en) 2002-10-31
PL361230A1 (en) 2004-10-04
HUP0400913A2 (en) 2006-11-28
MXPA03002963A (en) 2005-01-25
JP2015212300A (en) 2015-11-26
AU2002211462A1 (en) 2002-04-22
KR20030059173A (en) 2003-07-07
JP2013128486A (en) 2013-07-04
NO20031532L (en) 2003-04-04
SK5232003A3 (en) 2004-06-08
CZ20031166A3 (en) 2004-04-14
JP2004510817A (en) 2004-04-08
CA2422744A1 (en) 2002-04-18
HRP20030347A2 (en) 2005-04-30
IS6766A (en) 2003-04-01
EP1330245A1 (en) 2003-07-30
JP2005013238A (en) 2005-01-20
IL155194A0 (en) 2003-11-23
JP2009268479A (en) 2009-11-19
NO20031532D0 (en) 2003-04-04
WO2002030415A1 (en) 2002-04-18
JP2006036781A (en) 2006-02-09

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Effective date: 20040902

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Ipc: 7A 61K 31/19 A

17Q First examination report despatched

Effective date: 20041013

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: TEVA GYOGYSZERGYAR RESZVENYTARSASAG

RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: TEVA GYOGYSZERGYAR ZARTKOERUEN MUKOEDO RESZVENYTAR

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