EP4031121A4 - Dosage forms and methods for enantiomerically enriched or pure bupropion - Google Patents

Dosage forms and methods for enantiomerically enriched or pure bupropion Download PDF

Info

Publication number: EP4031121A4
Authority: EP; European Patent Office
Prior art keywords: methods; dosage forms; enantiomerically enriched; pure bupropion; bupropion
Prior art date: 2019-09-20
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

EP20866164.5A

Other languages

German (de)

French (fr)

Other versions

EP4031121A1 (en

Inventor

Herriot TABUTEAU

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.)

Axsome Therapeutics Inc

Original Assignee

Axsome 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.)

2019-09-20

Filing date

2020-08-18

Publication date

2022-11-30

Family has litigation

First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=74884634&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=EP4031121(A4) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.

2019-09-20 Priority claimed from PCT/US2019/052210 external-priority patent/WO2020061486A2/en

2020-03-26 Priority claimed from US16/830,637 external-priority patent/US20200222339A1/en

2020-06-22 Priority claimed from US16/907,691 external-priority patent/US11433035B2/en

2020-08-18 Application filed by Axsome Therapeutics Inc filed Critical Axsome Therapeutics Inc

2022-07-27 Publication of EP4031121A1 publication Critical patent/EP4031121A1/en

2022-11-30 Publication of EP4031121A4 publication Critical patent/EP4031121A4/en

Status Pending legal-status Critical Current

Links

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
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
- 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
- A61P25/24—Antidepressants
- 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

Landscapes

Health & Medical Sciences (AREA)
Medicinal Chemistry (AREA)
Veterinary Medicine (AREA)
Public Health (AREA)
General Health & Medical Sciences (AREA)
Animal Behavior & Ethology (AREA)
Life Sciences & Earth Sciences (AREA)
Chemical & Material Sciences (AREA)
Pharmacology & Pharmacy (AREA)
Epidemiology (AREA)
Neurology (AREA)
Bioinformatics & Cheminformatics (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Chemical Kinetics & Catalysis (AREA)
Neurosurgery (AREA)
Biomedical Technology (AREA)
General Chemical & Material Sciences (AREA)
Engineering & Computer Science (AREA)
Psychiatry (AREA)
Emergency Medicine (AREA)
Pain & Pain Management (AREA)
Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Medicinal Preparation (AREA)
Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

EP20866164.5A 2019-09-20 2020-08-18 Dosage forms and methods for enantiomerically enriched or pure bupropion Pending EP4031121A4 (en)

Applications Claiming Priority (7)

Application Number	Priority Date	Filing Date	Title
PCT/US2019/052210 WO2020061486A2 (en)	2018-09-20	2019-09-20	Dosage forms and methods for enantiomerically enriched or pure bupropion
US202062971174P	2020-02-06	2020-02-06
US202062978626P	2020-02-19	2020-02-19
US202062992060P	2020-03-19	2020-03-19
US16/830,637 US20200222339A1 (en)	2018-09-20	2020-03-26	Dosage forms and methods for enantiomerically enriched or pure bupropion
US16/907,691 US11433035B2 (en)	2018-09-20	2020-06-22	Dosage forms and methods for enantiomerically enriched or pure bupropion
PCT/US2020/046755 WO2021055124A1 (en)	2019-09-20	2020-08-18	Dosage forms and methods for enantiomerically enriched or pure bupropion

Publications (2)

Publication Number	Publication Date
EP4031121A1 EP4031121A1 (en)	2022-07-27
EP4031121A4 true EP4031121A4 (en)	2022-11-30

Family

ID=74884634

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP20866164.5A Pending EP4031121A4 (en)	2019-09-20	2020-08-18	Dosage forms and methods for enantiomerically enriched or pure bupropion

Country Status (15)

Country	Link
EP (1)	EP4031121A4 (en)
JP (2)	JP2022549192A (en)
KR (1)	KR20220066930A (en)
CN (1)	CN114423417A (en)
AU (3)	AU2020349419B2 (en)
BR (1)	BR112022005045A2 (en)
CA (2)	CA3287347A1 (en)
CO (1)	CO2022003126A2 (en)
CR (1)	CR20220119A (en)
EC (1)	ECSP22030119A (en)
IL (1)	IL291514A (en)
MX (1)	MX2022003346A (en)
NZ (1)	NZ786429A2 (en)
PE (1)	PE20221314A1 (en)
WO (1)	WO2021055124A1 (en)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
MX2022003346A (en) *	2019-09-20	2022-04-11	Axsome Therapeutics Inc	DOSAGE FORMS AND METHODS FOR ENANTIOMERICALLY ENRICHED OR PURE BUPROPION.

Citations (3)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
MX2013014166A (en) *	2013-12-03	2015-06-10	Inst De Investigacion En Quimica Aplic S A De C V	Active enantiomers and the salts thereof for treating obesity.
US9732031B2 (en) *	2013-12-20	2017-08-15	Deuterx, Llc	Methods of treating neurological and other disorders using enantiopure deuterium-enriched bupropion
WO2019165379A1 (en) *	2018-02-23	2019-08-29	Axsome Therapeutics, Inc.	Dosage forms and methods for enantiomerically enriched or pure bupropion

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
WO1999038502A1 (en) *	1998-01-29	1999-08-05	Sepracor Inc.	Pharmaceutical uses of optically pure (+)-bupropion
US6150420A (en) *	1998-06-01	2000-11-21	Theramax, Inc.	Method for enhanced brain delivery of bupropion
US20190216800A1 (en) *	2013-11-05	2019-07-18	Axsome Therapeutics, Inc.	Dosage forms and methods for enantiomerically enriched or pure bupropion
MX2022003346A (en) *	2019-09-20	2022-04-11	Axsome Therapeutics Inc	DOSAGE FORMS AND METHODS FOR ENANTIOMERICALLY ENRICHED OR PURE BUPROPION.

2020
- 2020-08-18 MX MX2022003346A patent/MX2022003346A/en unknown
- 2020-08-18 CA CA3287347A patent/CA3287347A1/en active Pending
- 2020-08-18 JP JP2022517743A patent/JP2022549192A/en active Pending
- 2020-08-18 PE PE2022000441A patent/PE20221314A1/en unknown
- 2020-08-18 KR KR1020227013095A patent/KR20220066930A/en active Pending
- 2020-08-18 EP EP20866164.5A patent/EP4031121A4/en active Pending
- 2020-08-18 NZ NZ786429A patent/NZ786429A2/en active IP Right Revival
- 2020-08-18 CN CN202080065520.4A patent/CN114423417A/en active Pending
- 2020-08-18 CR CR20220119A patent/CR20220119A/en unknown
- 2020-08-18 WO PCT/US2020/046755 patent/WO2021055124A1/en not_active Ceased
- 2020-08-18 CA CA3154718A patent/CA3154718C/en active Active
- 2020-08-18 BR BR112022005045A patent/BR112022005045A2/en unknown
- 2020-08-18 AU AU2020349419A patent/AU2020349419B2/en active Active
2022
- 2022-03-18 CO CONC2022/0003126A patent/CO2022003126A2/en unknown
- 2022-03-20 IL IL291514A patent/IL291514A/en unknown
- 2022-04-13 EC ECSENADI202230119A patent/ECSP22030119A/en unknown
2024
- 2024-01-05 AU AU2024200081A patent/AU2024200081B2/en active Active
- 2024-02-22 JP JP2024025971A patent/JP2024059812A/en active Pending
2026
- 2026-02-25 AU AU2026201399A patent/AU2026201399A1/en active Pending

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
MX2013014166A (en) *	2013-12-03	2015-06-10	Inst De Investigacion En Quimica Aplic S A De C V	Active enantiomers and the salts thereof for treating obesity.
US9732031B2 (en) *	2013-12-20	2017-08-15	Deuterx, Llc	Methods of treating neurological and other disorders using enantiopure deuterium-enriched bupropion
WO2019165379A1 (en) *	2018-02-23	2019-08-29	Axsome Therapeutics, Inc.	Dosage forms and methods for enantiomerically enriched or pure bupropion

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
KHARASCH EVAN D. ET AL: "Stereoselective Bupropion Hydroxylation as an In Vivo Phenotypic Probe for Cytochrome P4502B6 (CYP2B6) Activity", THE JOURNAL OF CLINICAL PHARMACOLOGY, vol. 48, no. 4, 1 April 2008 (2008-04-01), US, pages 464 - 474, XP093235496, ISSN: 0091-2700, DOI: 10.1177/0091270008314254 *
MUSSO ET AL: "Synthesis and evaluation of the antidepressant activity of the enentiomers of bupropion", CHIRALITY, WILEY-LISS, NEW YORK, US, vol. 5, no. 7, 1 January 1993 (1993-01-01), pages 495 - 500, XP002107656, ISSN: 0899-0042, DOI: 10.1002/CHIR.530050704 *
See also references of WO2021055124A1 *

Also Published As

Publication number	Publication date
KR20220066930A (en)	2022-05-24
ECSP22030119A (en)	2022-05-31
NZ786429A (en)	2025-08-29
PE20221314A1 (en)	2022-09-07
JP2022549192A (en)	2022-11-24
AU2020349419B2 (en)	2023-11-02
AU2020349419A1 (en)	2022-03-24
NZ786429A2 (en)	2026-01-30
CO2022003126A2 (en)	2022-04-19
MX2022003346A (en)	2022-04-11
IL291514A (en)	2022-05-01
BR112022005045A2 (en)	2022-07-05
CR20220119A (en)	2022-06-22
AU2026201399A1 (en)	2026-03-19
CA3154718C (en)	2026-02-24
JP2024059812A (en)	2024-05-01
WO2021055124A1 (en)	2021-03-25
CA3287347A1 (en)	2025-11-29
CA3154718A1 (en)	2021-03-25
CN114423417A (en)	2022-04-29
EP4031121A1 (en)	2022-07-27
AU2024200081A1 (en)	2024-01-25
AU2024200081B2 (en)	2025-11-27

Legal Events

Date	Code	Title	Description
2021-03-27	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: THE INTERNATIONAL PUBLICATION HAS BEEN MADE
2022-06-24	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
2022-06-24	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: REQUEST FOR EXAMINATION WAS MADE
2022-07-27	17P	Request for examination filed	Effective date: 20220324
2022-07-27	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
2022-09-16	REG	Reference to a national code	Ref country code: HK Ref legal event code: DE Ref document number: 40068404 Country of ref document: HK
2022-10-24	REG	Reference to a national code	Ref country code: DE Ref legal event code: R079 Free format text: PREVIOUS MAIN CLASS: A61K0031135000 Ipc: A61K0031137000
2022-11-30	A4	Supplementary search report drawn up and despatched	Effective date: 20221028
2022-11-30	RIC1	Information provided on ipc code assigned before grant	Ipc: A61K 9/20 20060101ALI20221024BHEP Ipc: A61P 25/24 20060101ALI20221024BHEP Ipc: A61K 31/137 20060101AFI20221024BHEP
2022-12-28	DAV	Request for validation of the european patent (deleted)
2022-12-28	DAX	Request for extension of the european patent (deleted)
2023-06-21	P01	Opt-out of the competence of the unified patent court (upc) registered	Effective date: 20230515
2024-12-20	STAA	Information on the status of an ep patent application or granted ep patent	Free format text: STATUS: EXAMINATION IS IN PROGRESS
2025-01-22	17Q	First examination report despatched	Effective date: 20250102

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