BR122020005056B1 - Método para preparar uma preparação oral que compreende cloridrato de n-[4-[4-(1,2- benziso-tiazol-3-il)-1-piperazinil]-(2r,3r)-2,3-tetrametileno-butil]-(1r,2s,3r,4s)-2,3-biciclo[2,2,1] heptanodicarboxiimida (lurasidona) - Google Patents
Método para preparar uma preparação oral que compreende cloridrato de n-[4-[4-(1,2- benziso-tiazol-3-il)-1-piperazinil]-(2r,3r)-2,3-tetrametileno-butil]-(1r,2s,3r,4s)-2,3-biciclo[2,2,1] heptanodicarboxiimida (lurasidona) Download PDFInfo
- Publication number
- BR122020005056B1 BR122020005056B1 BR122020005056-0A BR122020005056A BR122020005056B1 BR 122020005056 B1 BR122020005056 B1 BR 122020005056B1 BR 122020005056 A BR122020005056 A BR 122020005056A BR 122020005056 B1 BR122020005056 B1 BR 122020005056B1
- Authority
- BR
- Brazil
- Prior art keywords
- lurasidone
- water
- preparation
- pregelatinized starch
- soluble
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D417/00—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00
- C07D417/02—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 containing two hetero rings
- C07D417/12—Heterocyclic compounds containing two or more hetero rings, at least one ring having nitrogen and sulfur atoms as the only ring hetero atoms, not provided for by group C07D415/00 containing two hetero rings linked by a chain containing hetero atoms as chain links
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Organic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Physiology (AREA)
- Inorganic Chemistry (AREA)
- Nutrition Science (AREA)
- Psychiatry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2005153508 | 2005-05-26 | ||
| JP2005-153508 | 2005-05-26 | ||
| PCT/JP2006/310571 WO2006126681A1 (ja) | 2005-05-26 | 2006-05-26 | 医薬品組成物 |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| BR122020005056A2 BR122020005056A2 (enExample) | 2010-11-23 |
| BR122020005056A8 BR122020005056A8 (pt) | 2022-11-22 |
| BR122020005056B1 true BR122020005056B1 (pt) | 2023-01-10 |
Family
ID=37452103
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BR122020005056-0A BR122020005056B1 (pt) | 2005-05-26 | 2006-05-26 | Método para preparar uma preparação oral que compreende cloridrato de n-[4-[4-(1,2- benziso-tiazol-3-il)-1-piperazinil]-(2r,3r)-2,3-tetrametileno-butil]-(1r,2s,3r,4s)-2,3-biciclo[2,2,1] heptanodicarboxiimida (lurasidona) |
| BRPI0611409A BRPI0611409B8 (pt) | 2005-05-26 | 2006-05-26 | preparação oral compreendendo lurasidona |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| BRPI0611409A BRPI0611409B8 (pt) | 2005-05-26 | 2006-05-26 | preparação oral compreendendo lurasidona |
Country Status (22)
| Country | Link |
|---|---|
| US (5) | US8729085B2 (enExample) |
| EP (2) | EP1884242B1 (enExample) |
| JP (2) | JP4733120B2 (enExample) |
| KR (2) | KR101380088B1 (enExample) |
| CN (2) | CN102048734B (enExample) |
| AU (1) | AU2006250340C1 (enExample) |
| BE (1) | BE2014C057I2 (enExample) |
| BR (2) | BR122020005056B1 (enExample) |
| CA (1) | CA2606510C (enExample) |
| CY (2) | CY1114118T1 (enExample) |
| DK (2) | DK1884242T3 (enExample) |
| ES (2) | ES2408687T3 (enExample) |
| FR (1) | FR14C0069I2 (enExample) |
| HU (1) | HUS1400051I1 (enExample) |
| LU (1) | LU92550I2 (enExample) |
| MX (1) | MX2007014872A (enExample) |
| NL (1) | NL300690I2 (enExample) |
| PL (1) | PL1884242T3 (enExample) |
| PT (1) | PT1884242E (enExample) |
| RU (1) | RU2398586C3 (enExample) |
| SI (1) | SI1884242T1 (enExample) |
| WO (1) | WO2006126681A1 (enExample) |
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| WO2006123678A1 (ja) | 2005-05-18 | 2006-11-23 | Dainippon Sumitomo Pharma Co., Ltd. | ドロキシドパを含有する安定な錠剤 |
| WO2006126681A1 (ja) | 2005-05-26 | 2006-11-30 | Dainippon Sumitomo Pharma Co., Ltd. | 医薬品組成物 |
| CN101945657B (zh) * | 2008-02-11 | 2015-04-22 | 大日本住友制药株式会社 | 具有改善的溶出性的片剂 |
| WO2009151072A1 (ja) | 2008-06-13 | 2009-12-17 | 大日本住友製薬株式会社 | 口腔内速崩壊錠及びその製造方法 |
| JP5694773B2 (ja) * | 2008-09-30 | 2015-04-01 | テバ製薬株式会社 | 圧縮成型製剤およびその製造方法 |
| SMT201700097T1 (it) | 2009-05-19 | 2017-03-08 | Celgene Corp | Formulazioni di 4-ammino-2-(2,6-diossopiperidin-3-il)isoindolin-1,3-dione |
| WO2012053654A1 (en) | 2010-10-18 | 2012-04-26 | Dainippon Sumitomo Pharma Co., Ltd. | Sustained-release formulation for injection |
| WO2012063246A1 (en) * | 2010-11-11 | 2012-05-18 | Mapi Pharma Ltd. | Amorphous form of lurasidone hydrochloride |
| WO2012107890A2 (en) * | 2011-02-10 | 2012-08-16 | Ranbaxy Laboratories Limited | Crystalline forms of lurasidone hydrochloride |
| WO2012156981A1 (en) | 2011-05-13 | 2012-11-22 | Cadila Healthcare Limited | Pharmaceutical compositions of lurasidone |
| WO2013014665A1 (en) | 2011-07-28 | 2013-01-31 | Mapi Pharma Ltd. | Intermediate compounds and process for the preparation of lurasidone and salts thereof |
| CN102911169B (zh) * | 2011-08-02 | 2015-05-06 | 上海医药工业研究院 | 一种卢拉西酮的制备方法 |
| US20140243383A1 (en) | 2011-08-24 | 2014-08-28 | Cadila Healthcare Limited | Pharmaceutical compositions of silodosin |
| CN103446071B (zh) * | 2012-05-29 | 2017-12-19 | 江苏豪森药业集团有限公司 | 一种口服片剂及其制备方法和用途 |
| CN102688209A (zh) * | 2012-06-21 | 2012-09-26 | 李兴惠 | 鲁拉西酮片和制备方法 |
| CN102688210A (zh) * | 2012-06-21 | 2012-09-26 | 李兴惠 | 鲁拉西酮的药物组合物和制备方法 |
| CN106074414B (zh) * | 2012-07-12 | 2019-01-18 | 成都康弘药业集团股份有限公司 | 一种含有鲁拉西酮的口腔崩解片及其制备方法 |
| CN103006661B (zh) * | 2012-12-06 | 2015-02-18 | 江苏先声药物研究有限公司 | 一种含有盐酸鲁拉西酮的制剂及其制备方法 |
| US20150157628A1 (en) * | 2013-12-11 | 2015-06-11 | Saravanan Kannusamy | Pharmaceutical compositions of Lurasidone and Process for preparation thereof |
| WO2016012898A1 (en) | 2014-07-25 | 2016-01-28 | Lupin Limited | Oral pharmaceutical composition of lurasidone |
| CN104606133A (zh) * | 2015-01-07 | 2015-05-13 | 万特制药(海南)有限公司 | 鲁拉西酮口服混悬液及其制备方法 |
| WO2016139683A2 (en) * | 2015-03-05 | 2016-09-09 | Jubilant Generics Limited | Pharmaceutical compositions of lurasidone and process for preparing the same |
| DE102016205950A1 (de) * | 2016-04-08 | 2017-10-12 | Dietrich Seidel | Mittel zur Verwendung bei entzündlichen Zuständen der Schleimhäute |
| WO2018083117A1 (en) * | 2016-11-02 | 2018-05-11 | Sanovel Ilac Sanayi Ve Ticaret A.S. | Solid oral pharmaceutical compositions of lurasidone hydrochloride |
| CN108567758A (zh) * | 2017-03-08 | 2018-09-25 | 湖南洞庭药业股份有限公司 | 盐酸鲁拉西酮片剂及其制备方法 |
| EP3668515A4 (en) * | 2017-08-18 | 2021-05-12 | Abbvie Inc. | PHARMACEUTICAL FORMULATIONS FOR THE TREATMENT OF ENDOMETRIOSIS, UTERINE FIBROMAS, POLYCYSTIC OVARY SYNDROME OR ADENOMYOSIS |
| CN107854445A (zh) * | 2017-12-17 | 2018-03-30 | 佛山市弘泰药物研发有限公司 | 一种盐酸鲁拉西酮分散片及其制备方法 |
| CN107875122A (zh) * | 2017-12-17 | 2018-04-06 | 佛山市弘泰药物研发有限公司 | 一种盐酸鲁拉西酮自微乳制剂及其制备方法 |
| CN107854446A (zh) * | 2017-12-19 | 2018-03-30 | 佛山市弘泰药物研发有限公司 | 一种盐酸鲁拉西酮口崩片及其制备方法 |
| CN111989101A (zh) | 2018-02-28 | 2020-11-24 | 大日本住友制药株式会社 | 具有受控溶出的水性悬浮液型药物制剂 |
| WO2019197464A1 (de) | 2018-04-10 | 2019-10-17 | Z-Catering Mitte Gmbh | Vorrichtung zur aufwärmung von in verpackungseinheiten konserviereten speisen und zum bereitstellen von gemeinschaftsverpflegung |
| KR102286499B1 (ko) * | 2018-04-13 | 2021-08-05 | 주식회사 삼양홀딩스 | 레날리도마이드를 포함하는 약제학적 조성물 |
| CA3153004A1 (en) * | 2019-09-25 | 2021-04-01 | Nobelpharma Co., Ltd. | Granule having masked unpleasant taste and method for producing same |
| WO2022042646A1 (zh) * | 2020-08-26 | 2022-03-03 | 浙江华海药业股份有限公司 | 盐酸鲁拉西酮组合物及其制备方法 |
| AT17300U3 (de) * | 2020-12-03 | 2022-02-15 | G L Pharma Gmbh | Feste orale pharmazeutische Zusammensetzung |
| CA3199523A1 (en) | 2020-12-23 | 2022-06-30 | Alphanavi Pharma Inc. | Oral solid preparation |
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| WO2006126681A1 (ja) | 2005-05-26 | 2006-11-30 | Dainippon Sumitomo Pharma Co., Ltd. | 医薬品組成物 |
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2006
- 2006-05-26 WO PCT/JP2006/310571 patent/WO2006126681A1/ja not_active Ceased
- 2006-05-26 KR KR1020077027270A patent/KR101380088B1/ko active Active
- 2006-05-26 US US11/919,678 patent/US8729085B2/en active Active
- 2006-05-26 BR BR122020005056-0A patent/BR122020005056B1/pt active IP Right Grant
- 2006-05-26 DK DK06746900.7T patent/DK1884242T3/da active
- 2006-05-26 EP EP06746900.7A patent/EP1884242B1/en active Active
- 2006-05-26 ES ES06746900T patent/ES2408687T3/es active Active
- 2006-05-26 CA CA2606510A patent/CA2606510C/en active Active
- 2006-05-26 CN CN2010105647842A patent/CN102048734B/zh not_active Expired - Fee Related
- 2006-05-26 DK DK11181100.6T patent/DK2422783T3/en active
- 2006-05-26 CN CN2006800182234A patent/CN101184489B/zh not_active Expired - Fee Related
- 2006-05-26 MX MX2007014872A patent/MX2007014872A/es active IP Right Grant
- 2006-05-26 ES ES11181100.6T patent/ES2535478T3/es active Active
- 2006-05-26 EP EP20110181100 patent/EP2422783B1/en active Active
- 2006-05-26 KR KR1020137027051A patent/KR101552033B1/ko active Active
- 2006-05-26 PL PL06746900T patent/PL1884242T3/pl unknown
- 2006-05-26 JP JP2007517921A patent/JP4733120B2/ja active Active
- 2006-05-26 RU RU2007148997A patent/RU2398586C3/ru not_active Application Discontinuation
- 2006-05-26 PT PT67469007T patent/PT1884242E/pt unknown
- 2006-05-26 AU AU2006250340A patent/AU2006250340C1/en active Active
- 2006-05-26 SI SI200631567T patent/SI1884242T1/sl unknown
- 2006-05-26 BR BRPI0611409A patent/BRPI0611409B8/pt active IP Right Grant
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2011
- 2011-03-18 JP JP2011061211A patent/JP5285105B2/ja active Active
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2013
- 2013-05-14 CY CY20131100384T patent/CY1114118T1/el unknown
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2014
- 2014-02-18 US US14/183,283 patent/US8883794B2/en active Active
- 2014-09-15 HU HUS1400051C patent/HUS1400051I1/hu unknown
- 2014-09-16 FR FR14C0069C patent/FR14C0069I2/fr active Active
- 2014-09-16 NL NL300690C patent/NL300690I2/nl unknown
- 2014-09-17 BE BE2014C057C patent/BE2014C057I2/fr unknown
- 2014-09-18 CY CY2014039C patent/CY2014039I2/el unknown
- 2014-09-18 LU LU92550C patent/LU92550I2/xx unknown
- 2014-10-10 US US14/512,189 patent/US9555027B2/en active Active
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2015
- 2015-06-08 US US14/733,204 patent/US9907794B2/en active Active
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2018
- 2018-02-06 US US15/889,893 patent/US20180161322A1/en not_active Abandoned
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Legal Events
| Date | Code | Title | Description |
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| B07A | Application suspended after technical examination (opinion) [chapter 7.1 patent gazette] | ||
| B09B | Patent application refused [chapter 9.2 patent gazette] | ||
| B12B | Appeal against refusal [chapter 12.2 patent gazette] | ||
| B25D | Requested change of name of applicant approved |
Owner name: SUMITOMO PHARMA CO., LTD. (JP) |
|
| B25G | Requested change of headquarter approved |
Owner name: SUMITOMO PHARMA CO., LTD. (JP) |
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| B16A | Patent or certificate of addition of invention granted [chapter 16.1 patent gazette] |
Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 26/05/2006, OBSERVADAS AS CONDICOES LEGAIS. PATENTE CONCEDIDA CONFORME ADI 5.529/DF, QUE DETERMINA A ALTERACAO DO PRAZO DE CONCESSAO. |