CA2637672C - Sublingual fentanyl spray - Google Patents

Sublingual fentanyl spray Download PDF

Info

Publication number
CA2637672C
CA2637672C CA2637672A CA2637672A CA2637672C CA 2637672 C CA2637672 C CA 2637672C CA 2637672 A CA2637672 A CA 2637672A CA 2637672 A CA2637672 A CA 2637672A CA 2637672 C CA2637672 C CA 2637672C
Authority
CA
Canada
Prior art keywords
fentanyl
dose
sublingual
formulation
administration
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.)
Expired - Fee Related
Application number
CA2637672A
Other languages
English (en)
French (fr)
Other versions
CA2637672A1 (en
Inventor
S. George Kottayil
Venkat R. Goskonda
Zhongyuan Zhu
Linet Kattookaran
Neha N. Parikh
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.)
Insys Therapeutics Inc
Original Assignee
Insys Therapeutics Inc
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=38309867&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2637672(C) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Insys Therapeutics Inc filed Critical Insys Therapeutics Inc
Publication of CA2637672A1 publication Critical patent/CA2637672A1/en
Application granted granted Critical
Publication of CA2637672C publication Critical patent/CA2637672C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • A61K31/4468Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • 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
    • A61K31/435Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/445Non condensed piperidines, e.g. piperocaine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00Sprayers or atomisers specially adapted for therapeutic purposes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00Anaesthetics
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Landscapes

  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Pain & Pain Management (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Zoology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Rheumatology (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CA2637672A 2006-01-25 2007-01-25 Sublingual fentanyl spray Expired - Fee Related CA2637672C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US76205706P 2006-01-25 2006-01-25
US60/762,057 2006-01-25
PCT/US2007/002163 WO2007087431A2 (en) 2006-01-25 2007-01-25 Sublingual fentanyl spray

Publications (2)

Publication Number Publication Date
CA2637672A1 CA2637672A1 (en) 2007-08-02
CA2637672C true CA2637672C (en) 2012-07-24

Family

ID=38309867

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2637672A Expired - Fee Related CA2637672C (en) 2006-01-25 2007-01-25 Sublingual fentanyl spray

Country Status (16)

Country Link
US (6) US8486972B2 (enExample)
EP (2) EP2641595A1 (enExample)
JP (3) JP5241514B2 (enExample)
CN (1) CN101378735B (enExample)
AU (1) AU2007208229B2 (enExample)
BR (1) BRPI0707235B8 (enExample)
CA (1) CA2637672C (enExample)
DK (1) DK1976521T3 (enExample)
ES (1) ES2535233T3 (enExample)
MX (3) MX374396B (enExample)
NZ (1) NZ569949A (enExample)
PL (1) PL1976521T3 (enExample)
PT (1) PT1976521E (enExample)
RU (1) RU2432950C2 (enExample)
SI (1) SI1976521T1 (enExample)
WO (1) WO2007087431A2 (enExample)

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US10512644B2 (en) 2007-03-12 2019-12-24 Inheris Pharmaceuticals, Inc. Oligomer-opioid agonist conjugates
ES2668366T3 (es) * 2007-08-02 2018-05-17 Insys Development Company, Inc. Pulverización sublingual de fentanilo
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AU2010248776B2 (en) * 2009-05-15 2013-06-06 Baudax Bio, Inc. Sublingual dexmedetomidine compositions and methods of use thereof
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US10441538B2 (en) * 2014-07-08 2019-10-15 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
US10617686B2 (en) * 2014-07-08 2020-04-14 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
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US9855234B2 (en) * 2014-07-08 2018-01-02 Insys Development Company, Inc. Diclofenac sublingual spray
US20160199294A1 (en) * 2014-07-08 2016-07-14 Insys Development Company, Inc. Sublingual naloxone spray
US11135155B2 (en) 2014-07-08 2021-10-05 Hikma Pharmaceuticals Usa Inc. Liquid naloxone spray
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Also Published As

Publication number Publication date
JP5630877B2 (ja) 2014-11-26
WO2007087431A3 (en) 2008-09-25
PL1976521T3 (pl) 2015-10-30
BRPI0707235B1 (pt) 2020-04-14
RU2432950C2 (ru) 2011-11-10
US8835460B2 (en) 2014-09-16
CN101378735B (zh) 2013-04-03
US20140343100A1 (en) 2014-11-20
JP2013127003A (ja) 2013-06-27
US20070261695A1 (en) 2007-11-15
US9642797B2 (en) 2017-05-09
CA2637672A1 (en) 2007-08-02
BRPI0707235B8 (pt) 2021-05-25
US10016403B2 (en) 2018-07-10
US20170202820A1 (en) 2017-07-20
CN101378735A (zh) 2009-03-04
EP2641595A1 (en) 2013-09-25
ES2535233T3 (es) 2015-05-06
US20130327321A1 (en) 2013-12-12
RU2008130763A (ru) 2010-02-27
MX2020008616A (es) 2020-09-21
PT1976521E (pt) 2015-06-09
MX2008009522A (es) 2009-01-07
EP1976521B1 (en) 2015-03-11
BRPI0707235A2 (pt) 2011-04-26
JP2013056928A (ja) 2013-03-28
WO2007087431A2 (en) 2007-08-02
US20180303813A1 (en) 2018-10-25
US8486972B2 (en) 2013-07-16
DK1976521T3 (en) 2015-04-27
US20160193142A1 (en) 2016-07-07
US9289387B2 (en) 2016-03-22
EP1976521A2 (en) 2008-10-08
JP2009528272A (ja) 2009-08-06
EP1976521A4 (en) 2010-11-03
AU2007208229A1 (en) 2007-08-02
MX374396B (es) 2025-03-06
SI1976521T1 (sl) 2015-06-30
AU2007208229B2 (en) 2009-11-05
NZ569949A (en) 2011-10-28
JP5241514B2 (ja) 2013-07-17

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