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Glp 1 Compositions And Uses Thereof

Abstract: The present invention relates to pharmaceutical compositions of the GLP-1 peptide semaglutide comprising no more than 0.01 %(w/w) phenol, their preparation, kits comprising such compositions as well as uses thereof.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
10 March 2020
Publication Number
11/2020
Publication Type
INA
Invention Field
CHEMICAL
Status
Email
nncp-in@novonordisk.com
Parent Application

Applicants

NOVO NORDISK A/S
Novo Allé 2880 Bagsværd

Inventors

1. HORN MØLLER, Eva
Novo Allé 2880 Bagsværd
2. DUELUND SØRENSEN, Michael
Novo Allé 2880 Bagsværd
3. LUNDQVIST, Joakim
Novo Allé 2880 Bagsværd

Specification

CLAIMS
1. A liquid pharmaceutical composition comprising semaglutide and no more than 0.01
%(w/w) phenol, wherein said composition
a. is for parenteral administration;
5 b. is an aqueous solution comprising at least 60 %w/w water; or
c. further comprises one or more pharmaceutically acceptable excipients selected from the group consisting of a buffer or an isotonic agent.
2. The composition according to claim 1, wherein said composition comprises no phenol.
3. The composition according to any one of the preceding claims, wherein said composition
0 is an aqueous solution comprising at least 60 %w/w water.
4. The composition according to any one of the preceding claims, wherein the concentration of semaglutide is 0.5-10 mg/ml or 0.01-5 mg/ml of said composition.
5. The composition according to any one of the preceding claims, wherein said composition comprises one or more pharmaceutically acceptable excipients.
5 6. The composition according to claim 5, wherein said one or more pharmaceutically
acceptable excipients are selected from the group consisting of a buffer or an isotonic
agent. 7. The composition according to any one of the preceding claims, wherein said composition
comprises no preservative. 0 8. The composition according to any one of the preceding claims, wherein said composition
has a pH in the range of 6.0-10.0, such as pH 7.0-7.8.
9. The composition according to any one of the preceding claims, wherein said composition
is for parenteral administration.
10. The composition according to claim 9, wherein said parenteral administration is
5 subcutaneous administration.
11. A kit comprising a liquid pharmaceutical composition comprising semaglutide and no more than 0.01 %(w/w) and instructions for use.
12. A kit comprising a liquid pharmaceutical composition comprising semaglutide and no more than 0.01 %(w/w) phenol and an injection device for administration of said
0 composition to a subject, wherein said injection device is selected from the group
consisting of a durable pen and a prefilled pen.
13. The kit according to claim 11 or 12, wherein said pharmaceutical composition is as
defined in any one of claims 1-10.
14. A pharmaceutical composition as defined in any one of the preceding claims for use in
5 medicine.

15. The pharmaceutical composition as defined in any one of the preceding claims for use in the treatment of diabetes or obesity.

Documents

Application Documents

# Name Date
1 202047010224.pdf 2020-03-10
2 202047010224-STATEMENT OF UNDERTAKING (FORM 3) [10-03-2020(online)].pdf 2020-03-10
3 202047010224-PRIORITY DOCUMENTS [10-03-2020(online)].pdf 2020-03-10
4 202047010224-POWER OF AUTHORITY [10-03-2020(online)].pdf 2020-03-10
5 202047010224-FORM 18 [10-03-2020(online)].pdf 2020-03-10
6 202047010224-FORM 1 [10-03-2020(online)].pdf 2020-03-10
7 202047010224-DECLARATION OF INVENTORSHIP (FORM 5) [10-03-2020(online)].pdf 2020-03-10
8 202047010224-COMPLETE SPECIFICATION [10-03-2020(online)].pdf 2020-03-10
9 202047010224-FER.pdf 2020-07-27
10 202047010224-Proof of Right [06-08-2020(online)].pdf 2020-08-06
11 202047010224-Information under section 8(2) [08-09-2020(online)].pdf 2020-09-08
12 202047010224-FORM 3 [08-09-2020(online)].pdf 2020-09-08
13 202047010224-Certified Copy of Priority Document [23-10-2020(online)].pdf 2020-10-23
14 202047010224-OTHERS [22-01-2021(online)].pdf 2021-01-22
15 202047010224-FER_SER_REPLY [22-01-2021(online)].pdf 2021-01-22
16 202047010224-CLAIMS [22-01-2021(online)].pdf 2021-01-22
17 202047010224-Information under section 8(2) [05-03-2021(online)].pdf 2021-03-05
18 202047010224-FORM 3 [05-03-2021(online)].pdf 2021-03-05
19 202047010224-Information under section 8(2) [01-09-2021(online)].pdf 2021-09-01
20 202047010224-FORM 3 [01-09-2021(online)].pdf 2021-09-01
21 202047010224-Information under section 8(2) [17-02-2022(online)].pdf 2022-02-17
22 202047010224-FORM 3 [17-02-2022(online)].pdf 2022-02-17
23 202047010224-PRE GRANT OPPOSITION FORM [08-06-2022(online)].pdf 2022-06-08
24 202047010224-PRE GRANT OPPOSITION DOCUMENT [08-06-2022(online)].pdf 2022-06-08
25 202047010224-OTHERS [08-06-2022(online)].pdf 2022-06-08
26 202047010224-Information under section 8(2) [12-08-2022(online)].pdf 2022-08-12
27 202047010224-FORM 3 [12-08-2022(online)].pdf 2022-08-12
28 202047010224-FORM-26 [22-09-2022(online)].pdf 2022-09-22
29 202047010224-RELEVANT DOCUMENTS [15-12-2022(online)].pdf 2022-12-15
30 202047010224-POA [15-12-2022(online)].pdf 2022-12-15
31 202047010224-FORM 13 [15-12-2022(online)].pdf 2022-12-15
32 202047010224-Information under section 8(2) [09-02-2023(online)].pdf 2023-02-09
33 202047010224-FORM 3 [09-02-2023(online)].pdf 2023-02-09
34 202047010224-RELEVANT DOCUMENTS [29-06-2023(online)].pdf 2023-06-29
35 202047010224-FORM-26 [29-06-2023(online)].pdf 2023-06-29
36 202047010224-FORM 13 [29-06-2023(online)].pdf 2023-06-29
37 202047010224-Information under section 8(2) [08-08-2023(online)].pdf 2023-08-08
38 202047010224-FORM 3 [08-08-2023(online)].pdf 2023-08-08
39 202047010224-US(14)-HearingNotice-(HearingDate-14-03-2024).pdf 2024-02-05
40 202047010224-Information under section 8(2) [07-02-2024(online)].pdf 2024-02-07
41 202047010224-FORM 3 [07-02-2024(online)].pdf 2024-02-07
42 202047010224-Response to office action [23-02-2024(online)].pdf 2024-02-23
43 202047010224-REQUEST FOR ADJOURNMENT OF HEARING UNDER RULE 129A [11-03-2024(online)].pdf 2024-03-11
44 202047010224-Statement and Evidence [04-05-2024(online)].pdf 2024-05-04
45 202047010224-Response to office action [06-09-2024(online)].pdf 2024-09-06
46 202047010224-PRE GRANT OPPOSITION FORM [07-10-2025(online)].pdf 2025-10-07
47 202047010224-PRE GRANT OPPOSITION DOCUMENT [07-10-2025(online)].pdf 2025-10-07

Search Strategy

1 224searchstrtegyE_14-07-2020.pdf