EP3500261A4 - Liquid naloxone spray - Google Patents

Liquid naloxone spray Download PDF

Info

Publication number: EP3500261A4
Authority: EP; European Patent Office
Prior art keywords: naloxone spray; liquid; liquid naloxone; spray; naloxone
Prior art date: 2016-08-17
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.): Pending

Application number

EP17841883.6A

Other languages

German (de)

French (fr)

Other versions

EP3500261A1 (en

Inventor

Kiran AMANCHA

Shivani CHILAMPALLI

Thrimoorthy Potta

Ningxin YAN

Venkat R. Goskonda

Eshwaran Narayanan

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.)

Hikma Pharmaceuticals USA Inc

Original Assignee

Hikma Pharmaceuticals USA 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.)

2016-08-17

Filing date

2017-08-10

Publication date

2020-05-06

2016-08-17 Priority claimed from US15/238,909 external-priority patent/US10722510B2/en

2017-05-22 Priority claimed from US15/601,331 external-priority patent/US10617686B2/en

2017-08-10 Application filed by Hikma Pharmaceuticals USA Inc filed Critical Hikma Pharmaceuticals USA Inc

2019-06-26 Publication of EP3500261A1 publication Critical patent/EP3500261A1/en

2020-05-06 Publication of EP3500261A4 publication Critical patent/EP3500261A4/en

Status Pending legal-status Critical Current

Classifications

- 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
- A61K31/435—Heterocyclic 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
- A61K31/47—Quinolines; Isoquinolines
- A61K31/485—Morphinan derivatives, e.g. morphine, codeine
- 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
- 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
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- 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
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
- A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
- 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
- A61K9/0043—Nose
- 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
- A61K9/08—Solutions

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Life Sciences & Earth Sciences (AREA)
Public Health (AREA)
Animal Behavior & Ethology (AREA)
Veterinary Medicine (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
General Health & Medical Sciences (AREA)
Oil, Petroleum & Natural Gas (AREA)
Chemical Kinetics & Catalysis (AREA)
Engineering & Computer Science (AREA)
General Chemical & Material Sciences (AREA)
Proteomics, Peptides & Aminoacids (AREA)
Otolaryngology (AREA)
Emergency Medicine (AREA)
Medicinal Preparation (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

EP17841883.6A 2016-08-17 2017-08-10 Liquid naloxone spray Pending EP3500261A4 (en)

Applications Claiming Priority (3)

Application Number	Priority Date	Filing Date	Title
US15/238,909 US10722510B2 (en)	2014-07-08	2016-08-17	Liquid naloxone spray
US15/601,331 US10617686B2 (en)	2014-07-08	2017-05-22	Liquid naloxone spray
PCT/US2017/046198 WO2018034920A1 (en)	2016-08-17	2017-08-10	Liquid naloxone spray

Publications (2)

Publication Number	Publication Date
EP3500261A1 EP3500261A1 (en)	2019-06-26
EP3500261A4 true EP3500261A4 (en)	2020-05-06

Family

ID=61197156

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP17841883.6A Pending EP3500261A4 (en)	2016-08-17	2017-08-10	Liquid naloxone spray

Country Status (7)

Country	Link
EP (1)	EP3500261A4 (en)
JP (2)	JP7114570B2 (en)
CN (1)	CN109922805A (en)
AU (1)	AU2017312811B2 (en)
CA (1)	CA3033897C (en)
MA (1)	MA45995A (en)
WO (1)	WO2018034920A1 (en)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US8580801B2 (en)	2008-07-23	2013-11-12	Robert I. Henkin	Phosphodiesterase inhibitor treatment
WO2015126944A1 (en)	2014-02-18	2015-08-27	Henkin Robert I	Methods and compositions for diagnosing and treating loss and/or distortion of taste or smell
EP3500261A4 (en) *	2016-08-17	2020-05-06	Hikma Pharmaceuticals USA Inc.	Liquid naloxone spray
US20180193332A1 (en) *	2017-10-09	2018-07-12	Adapt Pharma Operations Limited	Low-temperature stable opioid antagonist solutions
CN113573705A (en) *	2018-12-19	2021-10-29	诺迪克控股公司	Therapeutic composition of intranasal lidocaine
WO2020172498A1 (en) *	2019-02-21	2020-08-27	Pharmaceutical Productions, Inc.	Naloxone formulations for sublingual and/or buccal administration
CN116474218A (en) *	2019-06-28	2023-07-25	四川普锐特药业有限公司	Drug fluid dispenser and dexmedetomidine nasal spray for maintaining uniformity of administration
EP4100012A4 (en) *	2020-02-05	2024-02-07	Summit Biosciences Inc.	MEDICINAL PRODUCTS INTENDED TO BE ADMINISTERED BY INTRANASAL ROUTE AND ASSOCIATED USES
WO2023133463A1 (en) *	2022-01-06	2023-07-13	Cyrano Therapeutics, Inc.	Improved nasal administration of parkinson's therapeutics

Citations (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
CN1575795A (en) *	2003-06-25	2005-02-09	中国人民解放军军事医学科学院毒物药物研究所	Naloxone hydrochloride nasal spray
US20160199294A1 (en) *	2014-07-08	2016-07-14	Insys Development Company, Inc.	Sublingual naloxone spray

Family Cites Families (14)

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Publication number	Priority date	Publication date	Assignee	Title
US14730A (en)		1856-04-22		Improvement in corn-harvesters
US585A (en)		1838-01-27		Apparatus for extinguishing sparks in the chimneys oe steam-boilers
US8627816B2 (en) *	2011-02-28	2014-01-14	Intelliject, Inc.	Medicament delivery device for administration of opioid antagonists including formulations for naloxone
TR201802716T4 (en)	2011-05-13	2018-03-21	Euro Celtique Sa	Intranasal pharmaceutical dosage forms containing naloxone.
SI2915525T1 (en) *	2011-09-19	2022-01-31	Orexo Ab	Sublingual abuse-resistant tablets comprising buprenorphine and naloxone
EP2877127B1 (en)	2012-07-26	2019-08-21	Synthes GmbH	Expandable implant
CA2881144A1 (en) *	2012-11-09	2014-05-09	Purdue Pharma	Pharmaceutical compositions comprising hydromorphone and naloxone
WO2015038327A1 (en)	2013-09-10	2015-03-19	Insys Pharma, Inc.	Sublingual buprenorphine spray
CN103637987B (en)	2013-12-09	2015-12-02	韩彬	The composition of liquid medicine of oxycodone
US9192570B2 (en)	2013-12-20	2015-11-24	AntiOP, Inc.	Intranasal naloxone compositions and methods of making and using same
US9480644B2 (en)	2014-03-14	2016-11-01	Opiant Pharmaceuticals, Inc.	Nasal drug products and methods of their use
CN106163499A (en)	2014-03-14	2016-11-23	欧皮安特制药有限公司	Nasal drug product and method of use thereof
CA2954370A1 (en)	2014-07-08	2016-01-14	Insys Pharma, Inc.	Sublingual naloxone spray
EP3500261A4 (en)	2016-08-17	2020-05-06	Hikma Pharmaceuticals USA Inc.	Liquid naloxone spray

2017
- 2017-08-10 EP EP17841883.6A patent/EP3500261A4/en active Pending
- 2017-08-10 CN CN201780063967.6A patent/CN109922805A/en active Pending
- 2017-08-10 JP JP2019508941A patent/JP7114570B2/en active Active
- 2017-08-10 MA MA045995A patent/MA45995A/en unknown
- 2017-08-10 AU AU2017312811A patent/AU2017312811B2/en active Active
- 2017-08-10 CA CA3033897A patent/CA3033897C/en active Active
- 2017-08-10 WO PCT/US2017/046198 patent/WO2018034920A1/en not_active Ceased
2022
- 2022-05-18 JP JP2022081328A patent/JP7455157B2/en active Active

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
CN1575795A (en) *	2003-06-25	2005-02-09	中国人民解放军军事医学科学院毒物药物研究所	Naloxone hydrochloride nasal spray
US20160199294A1 (en) *	2014-07-08	2016-07-14	Insys Development Company, Inc.	Sublingual naloxone spray

Also Published As

Publication number	Publication date
JP2022119843A (en)	2022-08-17
CN109922805A (en)	2019-06-21
JP7455157B2 (en)	2024-03-25
WO2018034920A1 (en)	2018-02-22
MA45995A (en)	2019-06-26
JP2019528278A (en)	2019-10-10
AU2017312811B2 (en)	2023-03-16
CA3033897A1 (en)	2018-02-22
CA3033897C (en)	2024-03-26
AU2017312811A1 (en)	2019-03-07
EP3500261A1 (en)	2019-06-26
AU2017312811A8 (en)	2019-03-14
JP7114570B2 (en)	2022-08-08

Publication	Publication Date	Title
EP3164221B8 (en)	2019-12-18	Liquid nebulization systems
AU2015242948A1 (en)	2016-05-12	Spray nozzle
GB201419803D0 (en)	2014-12-24	Spray booths
EP3239005A4 (en)	2018-08-22	Washer nozzle
EP3105146A4 (en)	2017-12-06	Spray delivery device
EP3253684A4 (en)	2018-09-26	Spray cap system
EP3500261A4 (en)	2020-05-06	Liquid naloxone spray
EP3199189A4 (en)	2018-07-11	Nozzle cap
EP3213822A4 (en)	2018-06-13	Trigger-type liquid sprayer
EP3177146A4 (en)	2018-01-03	Sublingual naloxone spray
EP3150287A4 (en)	2018-01-10	Trigger-type liquid sprayer
ZA201805751B (en)	2019-11-27	Spray device
EP3157684A4 (en)	2017-10-18	Illuminated water sprayer
EP3162451A4 (en)	2018-02-28	Trigger-type liquid sprayer
EP3162461A4 (en)	2018-04-25	Spray nozzle
EP3210671A4 (en)	2018-05-30	Spray orifice structure
EP3315036A4 (en)	2019-01-23	Atomization unit
EP3225314A4 (en)	2018-06-27	Trigger type liquid sprayer
EP3272702A4 (en)	2018-11-14	Liquid dispenser
EP3375529B8 (en)	2020-12-16	Electrostatic spray device
EP3479909A4 (en)	2020-02-26	Dispenser
EP3266725A4 (en)	2018-12-05	Nozzle
EP3375533A4 (en)	2018-10-24	Painting booth
EP3476765A4 (en)	2020-03-11	Pressurized spray
EP3375532A4 (en)	2018-10-24	Painting booth

Legal Events

Date	Code	Title	Description
2018-02-24	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE
2019-05-27	PUAI	Public reference made under article 153(3) epc to a published international application that has entered the european phase	Free format text: ORIGINAL CODE: 0009012
2019-05-27	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE
2019-06-26	17P	Request for examination filed	Effective date: 20190315
2019-06-26	AK	Designated contracting states	Kind code of ref document: A1 Designated state(s): AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR
2019-06-26	AX	Request for extension of the european patent	Extension state: BA ME
2020-03-04	RAP1	Party data changed (applicant data changed or rights of an application transferred)	Owner name: HIKMA PHARMACEUTICALS USA INC.
2020-05-06	A4	Supplementary search report drawn up and despatched	Effective date: 20200402
2020-05-06	RIC1	Information provided on ipc code assigned before grant	Ipc: A61K 9/00 20060101ALI20200328BHEP Ipc: A61K 47/18 20170101ALI20200328BHEP Ipc: A61K 31/485 20060101AFI20200328BHEP
2020-07-10	REG	Reference to a national code	Ref country code: HK Ref legal event code: DE Ref document number: 40011159 Country of ref document: HK
2023-06-21	P01	Opt-out of the competence of the unified patent court (upc) registered	Effective date: 20230513
2024-03-20	RAP3	Party data changed (applicant data changed or rights of an application transferred)	Owner name: HIKMA PHARMACEUTICALS USA INC.