SG11201906729RA - Topical cyclosporine-containing formulations and uses thereof - Google Patents

Topical cyclosporine-containing formulations and uses thereof

Info

Publication number
SG11201906729RA
SG11201906729RA SG11201906729RA SG11201906729RA SG11201906729RA SG 11201906729R A SG11201906729R A SG 11201906729RA SG 11201906729R A SG11201906729R A SG 11201906729RA SG 11201906729R A SG11201906729R A SG 11201906729RA SG 11201906729R A SG11201906729R A SG 11201906729RA
Authority
SG
Singapore
Prior art keywords
international
formulations
march
pct
applicant
Prior art date
Application number
SG11201906729RA
Inventor
Sidney L Weiss
Ashim K Mitra
Eugene J Mcnally
Original Assignee
Sun Pharma Global Fze
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=59744365&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=SG11201906729R(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sun Pharma Global Fze filed Critical Sun Pharma Global Fze
Publication of SG11201906729RA publication Critical patent/SG11201906729RA/en

Links

Classifications

    • 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
    • A61K9/0048Eye, e.g. artificial tears
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • A61K38/13Cyclosporins
    • 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
    • A61K31/20Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
    • A61K31/202Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • 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
    • A61K47/44Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/10Dispersions; Emulsions
    • A61K9/107Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Ophthalmology & Optometry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dispersion Chemistry (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

WO 17 / 15 1657 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (43) International Publication Date 8 September 2017 (08.09.2017) WIPO I PCT (10) International Publication Number WO 2017/151657 Al 111111111111110111011111111111010111110111011111111011111111111111111111111111110111111 Clin ica lly Sign ifican t Chang e from Base line ( >_ 1Omm) 15% p=0.128 (51) International Patent Classification: A61K 38/13 (2006.01) A61P 27/02 (2006.01) (21) International Application Number: PCT/US2017/020008 (22) International Filing Date: 28 February 2017 (28.02.2017) (25) Filing Language: English (26) Publication Language: English (30) Priority Data: 62/301,576 29 February 2016 (29.02.2016) US 62/302,058 1 March 2016 (01.03.2016) US 62/302,730 2 March 2016 (02.03.2016) US 62/311,177 21 March 2016 (21.03.2016) US (71) Applicant: OCULAR TECHNOLOGIES SARL [CH/CH]; Route de la Corniche 3B, 1066 Epalinges (CH). (72) Inventors; and (71) Applicants : WEISS, Sidney L. [US/US]; 6 Dawn Lane, Randolph, New Jersey 07869 (US). MITRA, Ashim K. [US/US]; 15065 Stearns Street, Overland Park, Kansas 66221 (US). MCNALLY, Eugene J. [US/US]; 3037 Bosshard Drive, Fitchburg, Wisconsin 53711 (US). (74) Agent: WOODHOUSE, Scott, M.; Medler Ferro Wood- house & Mills PLLC, 8201 Greensboro Drive, Suite 1060, McLean, VA 22102 (US). (81) Designated States (unless otherwise indicated, for every kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, ZW. (84) Designated States (unless otherwise indicated, for every kind of regional protection available): ARIPO (BW, GH, GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, [Continued on next page] (54) Title: TOPICAL CYCLOSPORINE-CONTAINING FORMULATIONS AND USES THEREOF (57) : Provided herein are formulations for topical 20% ophthalmic formulations containing 0.087-0.093 wt% of cyclosporine, and methods of making and using such formu- lations. In some aspects and embodiments the formulations 1 7 9 may include a polyoxyl lipid or fatty acid, and/or a polyalkoxylated alcohol and may include nanomicelles. Also included herein are methods of treating or preventing dis- eases or conditions, such as ocular diseases or conditions. 10% - 5% - 0% OTX-101 0.09% ;.:,° OTX101 0.05% /ehicle Figure I WO 2017/151657 Al MIDEDIMOMOIDEIR010131EMOHIMMERVOIMIE DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). Declarations under Rule 4.17: as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(ii)) as to the applicant's entitlement to claim the priority of the earlier application (Rule 4.17(iii)) Published: with international search report (Art. 21(3))
SG11201906729RA 2016-02-29 2017-02-28 Topical cyclosporine-containing formulations and uses thereof SG11201906729RA (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201662301576P 2016-02-29 2016-02-29
US201662302058P 2016-03-01 2016-03-01
US201662302730P 2016-03-02 2016-03-02
US201662311177P 2016-03-21 2016-03-21
PCT/US2017/020008 WO2017151657A1 (en) 2016-02-29 2017-02-28 Topical cyclosporine-containing formulations and uses thereof

Publications (1)

Publication Number Publication Date
SG11201906729RA true SG11201906729RA (en) 2019-08-27

Family

ID=59744365

Family Applications (1)

Application Number Title Priority Date Filing Date
SG11201906729RA SG11201906729RA (en) 2016-02-29 2017-02-28 Topical cyclosporine-containing formulations and uses thereof

Country Status (21)

Country Link
US (4) US10918694B2 (en)
EP (2) EP4410312A2 (en)
JP (2) JP7072517B2 (en)
KR (1) KR20180117661A (en)
CN (1) CN109843316A (en)
AU (2) AU2017227585C1 (en)
BR (1) BR112018067946A8 (en)
CA (1) CA3015626A1 (en)
DK (1) DK3423076T3 (en)
ES (1) ES2981702T3 (en)
FI (1) FI3423076T3 (en)
IL (1) IL268056A (en)
MX (1) MX2018010395A (en)
NZ (1) NZ755442A (en)
PL (1) PL3423076T3 (en)
PT (1) PT3423076T (en)
RU (1) RU2747455C2 (en)
SA (1) SA519410114B1 (en)
SG (1) SG11201906729RA (en)
WO (1) WO2017151657A1 (en)
ZA (1) ZA201904704B (en)

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Also Published As

Publication number Publication date
NZ755442A (en) 2023-04-28
AU2017227585A1 (en) 2018-10-18
US20190060397A1 (en) 2019-02-28
US10918694B2 (en) 2021-02-16
ZA201904704B (en) 2022-10-26
DK3423076T3 (en) 2024-07-08
RU2019130403A (en) 2021-03-26
MX2018010395A (en) 2018-11-29
SA519410114B1 (en) 2024-02-11
BR112018067946A8 (en) 2022-11-08
EP3423076B1 (en) 2024-04-17
JP2022110054A (en) 2022-07-28
AU2017227585C1 (en) 2022-05-26
PT3423076T (en) 2024-07-01
JP7547411B2 (en) 2024-09-09
WO2017151657A1 (en) 2017-09-08
RU2747455C2 (en) 2021-05-05
US20230083458A1 (en) 2023-03-16
US11951153B2 (en) 2024-04-09
ES2981702T3 (en) 2024-10-10
KR20180117661A (en) 2018-10-29
AU2017227585B2 (en) 2022-02-17
US20240197818A1 (en) 2024-06-20
FI3423076T3 (en) 2024-06-24
BR112018067946A2 (en) 2019-01-15
IL268056A (en) 2019-08-29
RU2019130403A3 (en) 2021-03-26
PL3423076T3 (en) 2024-08-19
JP7072517B2 (en) 2022-05-20
EP3423076A4 (en) 2019-11-27
EP3423076A1 (en) 2019-01-09
EP4410312A2 (en) 2024-08-07
US20210145924A1 (en) 2021-05-20
CN109843316A (en) 2019-06-04
JP2019507154A (en) 2019-03-14
AU2022203135A1 (en) 2022-06-02
CA3015626A1 (en) 2017-09-08

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