DK2931268T3 - GAMMA HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISEASES - Google Patents

GAMMA HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISEASES Download PDF

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Publication number
DK2931268T3
DK2931268T3 DK13863231.0T DK13863231T DK2931268T3 DK 2931268 T3 DK2931268 T3 DK 2931268T3 DK 13863231 T DK13863231 T DK 13863231T DK 2931268 T3 DK2931268 T3 DK 2931268T3
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Prior art keywords
ghb
salts
salt
mixture
present
Prior art date
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DK13863231.0T
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Danish (da)
English (en)
Inventor
Clark P Allphin
Michael Desjardin
Original Assignee
Jazz Pharmaceuticals Ireland Ltd
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.)
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=49596603&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK2931268(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Jazz Pharmaceuticals Ireland Ltd filed Critical Jazz Pharmaceuticals Ireland Ltd
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Publication of DK2931268T3 publication Critical patent/DK2931268T3/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/55Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
    • A61K31/554Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having at least one nitrogen and one sulfur as ring hetero atoms, e.g. clothiapine, diltiazem
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/04Centrally acting analgesics, e.g. opioids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/20Hypnotics; Sedatives

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Neurosurgery (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)
DK13863231.0T 2012-12-14 2013-12-13 GAMMA HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISEASES DK2931268T3 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261737695P 2012-12-14 2012-12-14
PCT/US2013/074954 WO2014093791A1 (en) 2012-12-14 2013-12-13 Gamma-hydroxybutyrate compositions and their use for the treatment of disorders

Publications (1)

Publication Number Publication Date
DK2931268T3 true DK2931268T3 (en) 2018-02-26

Family

ID=49596603

Family Applications (2)

Application Number Title Priority Date Filing Date
DK13863231.0T DK2931268T3 (en) 2012-12-14 2013-12-13 GAMMA HYDROXYBUTYRATE COMPOSITIONS AND THEIR USE FOR THE TREATMENT OF DISEASES
DK17202548.8T DK3335709T3 (da) 2012-12-14 2013-12-13 Gamma-hydroxybutyratsammensætninger og deres anvendelse til behandling af lidelser

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK17202548.8T DK3335709T3 (da) 2012-12-14 2013-12-13 Gamma-hydroxybutyratsammensætninger og deres anvendelse til behandling af lidelser

Country Status (24)

Country Link
US (9) US8591922B1 (enExample)
EP (3) EP2931268B1 (enExample)
JP (1) JP6215347B2 (enExample)
KR (1) KR102180343B1 (enExample)
CN (1) CN105025892B (enExample)
AU (1) AU2013359114B2 (enExample)
CA (1) CA2894876C (enExample)
CY (2) CY1119918T1 (enExample)
DK (2) DK2931268T3 (enExample)
ES (2) ES2827005T3 (enExample)
HR (1) HRP20201685T1 (enExample)
HU (1) HUE051060T2 (enExample)
IL (1) IL239355A (enExample)
IN (1) IN342829B (enExample)
LT (1) LT3335709T (enExample)
MX (1) MX366681B (enExample)
NO (1) NO3027826T3 (enExample)
PL (1) PL2931268T3 (enExample)
PT (2) PT3335709T (enExample)
SG (1) SG11201504637TA (enExample)
SI (1) SI3335709T1 (enExample)
TR (1) TR201802271T4 (enExample)
TW (2) TWI681770B (enExample)
WO (1) WO2014093791A1 (enExample)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11400065B2 (en) 2019-03-01 2022-08-02 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11839597B2 (en) 2016-07-22 2023-12-12 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12186296B1 (en) 2016-07-22 2025-01-07 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12478604B1 (en) 2016-07-22 2025-11-25 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics

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MX391660B (es) 2010-03-24 2025-03-21 Jazz Pharmaceuticals Inc Formas de dosis de liberacion controlada para substancias de farmaco de alta dosis, solubles en agua e higroscopicas
US8591922B1 (en) 2012-12-14 2013-11-26 Jazz Pharmacuticals, Inc. Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
US9050302B2 (en) 2013-03-01 2015-06-09 Jazz Pharmaceuticals Ireland Limited Method of administration of gamma hydroxybutyrate with monocarboxylate transporters
US10398662B1 (en) 2015-02-18 2019-09-03 Jazz Pharma Ireland Limited GHB formulation and method for its manufacture
CA3207643A1 (en) 2015-09-23 2017-03-30 XWPharma Ltd. Prodrugs of gamma-hydroxybutyric acid, compositions and uses thereof
FR3049463B1 (fr) 2016-04-01 2019-07-05 Debregeas Et Associes Pharma Doses unitaires a liberation immediate de ghb ou de l'un de ses sels therapeutiquement acceptables administrees par voie orale et leur utilisation pour maintenir l'abstinence alcoolique
US11000498B2 (en) 2016-07-22 2021-05-11 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US20180263936A1 (en) 2017-03-17 2018-09-20 Jazz Pharmaceuticals Ireland Limited Gamma-hydroxybutyrate compositions and their use for the treatment of disorders
IL275312B2 (en) * 2017-12-18 2024-09-01 Tris Pharma Inc Ghb pharmaceutical compositions comprising a floating interpenetrating polymer network forming system
US11337920B2 (en) 2017-12-18 2022-05-24 Tris Pharma, Inc. Pharmaceutical composition comprising GHB gastro-retentive raft forming systems having trigger pulse drug release
JP2021506984A (ja) 2017-12-18 2021-02-22 トリス・フアルマ・インコーポレーテツド トリガーパルス薬物放出を有する胃内滞留型raft形成システムを含む放出調節薬物粉末組成物
BR112021006027A2 (pt) 2018-11-19 2021-06-29 Jazz Pharmaceuticals Ireland Limited formulações de fármaco resistente a álcool
AU2020414694A1 (en) * 2019-12-24 2022-08-18 Jazz Pharmaceuticals Ireland Limited Gamma-hydroxybutyrate (GHB) dosing
TW202139986A (zh) 2020-02-21 2021-11-01 愛爾蘭商爵士製藥愛爾蘭有限責任公司 治療原發性嗜睡症之方法
KR102436227B1 (ko) * 2020-05-29 2022-08-24 주식회사 케이티앤지 기능성 물질이 코팅된 흡연물품용 팁페이퍼 및 상기 팁페이퍼의 코팅 방법
AU2021292406B2 (en) 2020-06-18 2024-03-14 XWPharma Ltd. Controlled release granulations of water-soluble active pharmaceutical ingredients
CN116261451A (zh) * 2020-07-24 2023-06-13 凯瑞康宁生物工程有限公司 γ-羟基丁酸衍生物的药物组合物和药物动力学
CN115666527B (zh) 2020-10-05 2025-03-07 凯瑞康宁生物工程有限公司 γ-羟基丁酸衍生物的修饰释放组合物
US20230404950A1 (en) 2020-10-08 2023-12-21 Jazz Pharmaceuticals Ireland Limited Sodium oxybate to treat idiopathic hypersomnia
WO2022082105A2 (en) 2020-10-16 2022-04-21 Jazz Pharmaceuticals Ireland Limited Treatment methods using ghb
TW202300139A (zh) 2021-03-19 2023-01-01 凱瑞康寧生技股份有限公司 γ-羟基丁酸衍生物的聯合釋放製劑的藥代動力學
US20240182401A1 (en) * 2021-03-20 2024-06-06 Alkem Laboratories Limited A process for the preparation of mixed oxybate salts and polymorphs thereof
US11877992B1 (en) 2021-06-07 2024-01-23 Kelly Kathleen Spinelli Gamma-hydroxybutyrate salts for the treatment of learning disorders
US11877993B1 (en) 2021-06-23 2024-01-23 Kelly Kathleen Spinelli Gamma-hydroxybutyrate salts for the treatment of psychological disorders
WO2023062018A1 (en) 2021-10-11 2023-04-20 Jazz Pharmaceuticals Ireland Limited Method of administering oxybate
US20250073191A1 (en) 2022-01-11 2025-03-06 Jazz Pharmaceuticals Ireland Limited Method of administering oxybate
AU2023257266A1 (en) * 2022-04-21 2024-08-22 Zevra Therapeutics, Inc. Gamma-hydroxybutyrate delivering compounds and processes for making and using them

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JP2564690B2 (ja) 1990-06-14 1996-12-18 三省製薬 株式会社 メラニン生成抑制外用剤
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US20180263936A1 (en) 2017-03-17 2018-09-20 Jazz Pharmaceuticals Ireland Limited Gamma-hydroxybutyrate compositions and their use for the treatment of disorders

Cited By (35)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12115142B2 (en) 2016-07-22 2024-10-15 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12115145B2 (en) 2016-07-22 2024-10-15 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12478604B1 (en) 2016-07-22 2025-11-25 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602512B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11602513B1 (en) 2016-07-22 2023-03-14 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11766418B2 (en) 2016-07-22 2023-09-26 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12263150B2 (en) 2016-07-22 2025-04-01 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11826335B2 (en) 2016-07-22 2023-11-28 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11839597B2 (en) 2016-07-22 2023-12-12 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11896572B2 (en) 2016-07-22 2024-02-13 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11986451B1 (en) 2016-07-22 2024-05-21 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12097176B2 (en) 2016-07-22 2024-09-24 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12097175B2 (en) 2016-07-22 2024-09-24 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12109186B2 (en) 2016-07-22 2024-10-08 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12115144B2 (en) 2016-07-22 2024-10-15 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12115143B2 (en) 2016-07-22 2024-10-15 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11504347B1 (en) 2016-07-22 2022-11-22 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12263151B2 (en) 2016-07-22 2025-04-01 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12128021B1 (en) 2016-07-22 2024-10-29 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12138239B2 (en) 2016-07-22 2024-11-12 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12144793B2 (en) 2016-07-22 2024-11-19 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12257223B2 (en) 2016-07-22 2025-03-25 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12239625B2 (en) 2016-07-22 2025-03-04 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12186296B1 (en) 2016-07-22 2025-01-07 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12186298B2 (en) 2016-07-22 2025-01-07 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12226388B2 (en) 2016-07-22 2025-02-18 Flamel Ireland Limited Modified release gamma- hydroxybutyrate formulations having improved pharmacokinetics
US12226389B2 (en) 2016-07-22 2025-02-18 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12226377B2 (en) 2019-03-01 2025-02-18 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US12167992B2 (en) 2019-03-01 2024-12-17 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US12167991B2 (en) 2019-03-01 2024-12-17 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US11400065B2 (en) 2019-03-01 2022-08-02 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US12303478B2 (en) 2019-03-01 2025-05-20 Flamel Ireland Limited Gamma-hydroxybutyrate compositions having improved pharmacokinetics in the fed state
US11779557B1 (en) 2022-02-07 2023-10-10 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US12295926B1 (en) 2022-02-07 2025-05-13 Flamel Ireland Limited Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
US11583510B1 (en) 2022-02-07 2023-02-21 Flamel Ireland Limited Methods of administering gamma hydroxybutyrate formulations after a high-fat meal

Also Published As

Publication number Publication date
CA2894876C (en) 2017-08-29
US10675258B2 (en) 2020-06-09
US20140171505A1 (en) 2014-06-19
IN342829B (enExample) 2016-07-01
US20200338029A1 (en) 2020-10-29
KR102180343B1 (ko) 2020-11-19
US8591922B1 (en) 2013-11-26
CA2894876A1 (en) 2014-06-19
KR20150100737A (ko) 2015-09-02
BR112015014007A2 (pt) 2017-07-11
CN105025892A (zh) 2015-11-04
WO2014093791A1 (en) 2014-06-19
PL2931268T3 (pl) 2018-06-29
CY1123498T1 (el) 2022-03-24
US8901173B2 (en) 2014-12-02
TW201831174A (zh) 2018-09-01
TWI681770B (zh) 2020-01-11
US20240156759A1 (en) 2024-05-16
IL239355A (en) 2017-05-29
MX366681B (es) 2019-07-19
US10195168B2 (en) 2019-02-05
EP2931268B1 (en) 2017-11-22
US20140171506A1 (en) 2014-06-19
JP2016503762A (ja) 2016-02-08
EP3335709B1 (en) 2020-08-12
US20220000815A1 (en) 2022-01-06
ES2660056T3 (es) 2018-03-20
AU2013359114B2 (en) 2017-01-19
TW201429469A (zh) 2014-08-01
AU2013359114A1 (en) 2015-07-02
NO3027826T3 (enExample) 2017-12-16
SG11201504637TA (en) 2015-07-30
CN105025892B (zh) 2018-03-20
US9132107B2 (en) 2015-09-15
PT3335709T (pt) 2020-10-21
DK3335709T3 (da) 2020-10-19
EP3335709A1 (en) 2018-06-20
LT3335709T (lt) 2020-11-25
IL239355A0 (en) 2015-07-30
JP6215347B2 (ja) 2017-10-18
HUE051060T2 (hu) 2021-03-01
HK1215181A1 (en) 2016-08-19
ES2827005T3 (es) 2021-05-19
TWI639425B (zh) 2018-11-01
HRP20201685T1 (hr) 2020-12-25
TR201802271T4 (tr) 2018-03-21
EP2931268A1 (en) 2015-10-21
PT2931268T (pt) 2018-02-27
US20170209396A1 (en) 2017-07-27
CY1119918T1 (el) 2018-06-27
EP3799867A1 (en) 2021-04-07
US9555017B2 (en) 2017-01-31
US20160058720A1 (en) 2016-03-03
EP2931268A4 (en) 2016-06-01
US20190224149A1 (en) 2019-07-25
US11554102B2 (en) 2023-01-17
SI3335709T1 (sl) 2021-01-29
MX2015007531A (es) 2016-03-11

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