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Solid Compositions For Oral Administration

Abstract: The present invention relates to solid compositions for oral administration comprising (i) a GLP-1 derivative and the SGLT2 inhibitor dapagliflozin or (ii) a GLP-1 derivative and a salt of NAC in combination with an SGLT2 inhibitor.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
09 December 2019
Publication Number
50/2019
Publication Type
INA
Invention Field
BIOTECHNOLOGY
Status
Email
nncp-in@novonordisk.com
Parent Application
Patent Number
Legal Status
Grant Date
2023-08-10
Renewal Date

Applicants

NOVO NORDISK A/S
NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd

Inventors

1. VEGGE, Andreas
NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd
2. SCHÉELE, Susanne
NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd
3. BJERREGAARD, Simon
NOVO NORDISK A/S, Novo Allé, DK-2880 Bagsværd

Specification

CLAIMS
1. A solid composition for oral administration comprising
(i) a GLP-1 derivative and dapagliflozin, or
(ii) a GLP-1 derivative and a salt of NAC in combination with an SGLT2
inhibitor.
2. A solid composition for oral administration comprising a GLP-1 derivative and dapagliflozin.
3. A solid composition for oral administration comprising a GLP-1 derivative, a salt of NAC, and empagliflozin.
4. The composition according to any one of the preceding claims, wherein said GLP-1 derivative has a size of no more than 12 kDa.
5. The composition according any one of the preceding claims, wherein said GLP-1 derivative is selected from the group consisting of semaglutide, Compound A, Compound B, Compound C, Compound D, and Compound E.
6. The composition according to any one of the preceding claims, wherein said GLP-1 derivative and/or dapagliflozin is in the form of a pharmaceutically acceptable salt, ester or solvate.
7. The composition according to any one of the preceding claims, wherein said composition comprises 5-300 mg SGLT2 inhibitor, 20-800 mg salt of NAC, such as SNAC, and optionally 0.1-100 mg GLP-1 derivative.
8. The composition according to any one of the preceding claims, wherein the dosage of said dapagliflozin is 0.5-50 mg per day and the dosage of said GLP-1 derivative is 0.1-100 mg per day.
9. The composition according to any one of the preceding claims, wherein said composition comprises one or more additional pharmaceutically acceptable excipients thereof.
10. The composition according to any one of the preceding claims, wherein said composition further comprises an absorption enhancer.
11. The composition according to any one of the preceding claims, wherein said absorption enhancer is a salt of NAC, such as SNAC.
12. The composition according to any one of the preceding claims, wherein said composition is in the form of a tablet, a capsule or a sachet.
13. The composition according to any one of the preceding claims, wherein the dosage of said composition administered is in the range of 200-1000 mg.

14. The composition according to any one of the preceding claims, wherein said composition is administered once daily.
15. The composition as defined in any one of the preceding claims for use in medicine.

Documents

Application Documents

# Name Date
1 201947050715.pdf 2019-12-09
2 201947050715-STATEMENT OF UNDERTAKING (FORM 3) [09-12-2019(online)].pdf 2019-12-09
3 201947050715-SEQUENCE LISTING(PDF) [09-12-2019(online)].pdf 2019-12-09
4 201947050715-SEQUENCE LISTING [09-12-2019(online)].txt 2019-12-09
5 201947050715-PRIORITY DOCUMENTS [09-12-2019(online)].pdf 2019-12-09
6 201947050715-POWER OF AUTHORITY [09-12-2019(online)].pdf 2019-12-09
7 201947050715-FORM 18 [09-12-2019(online)].pdf 2019-12-09
8 201947050715-FORM 1 [09-12-2019(online)].pdf 2019-12-09
9 201947050715-DECLARATION OF INVENTORSHIP (FORM 5) [09-12-2019(online)].pdf 2019-12-09
10 201947050715-COMPLETE SPECIFICATION [09-12-2019(online)].pdf 2019-12-09
11 201947050715-Proof of Right [27-02-2020(online)].pdf 2020-02-27
12 201947050715-FORM 3 [04-06-2020(online)].pdf 2020-06-04
13 201947050715-FORM 3 [03-12-2020(online)].pdf 2020-12-03
14 201947050715-FORM 3 [28-05-2021(online)].pdf 2021-05-28
15 201947050715-FORM 3 [16-11-2021(online)].pdf 2021-11-16
16 201947050715-FER.pdf 2022-03-22
17 201947050715-Information under section 8(2) [13-05-2022(online)].pdf 2022-05-13
18 201947050715-FORM 3 [13-05-2022(online)].pdf 2022-05-13
19 201947050715-OTHERS [20-09-2022(online)].pdf 2022-09-20
20 201947050715-FER_SER_REPLY [20-09-2022(online)].pdf 2022-09-20
21 201947050715-COMPLETE SPECIFICATION [20-09-2022(online)].pdf 2022-09-20
22 201947050715-CLAIMS [20-09-2022(online)].pdf 2022-09-20
23 201947050715-Information under section 8(2) [28-10-2022(online)].pdf 2022-10-28
24 201947050715-FORM 3 [28-10-2022(online)].pdf 2022-10-28
25 201947050715-RELEVANT DOCUMENTS [15-12-2022(online)].pdf 2022-12-15
26 201947050715-POA [15-12-2022(online)].pdf 2022-12-15
27 201947050715-FORM 13 [15-12-2022(online)].pdf 2022-12-15
28 201947050715-Information under section 8(2) [27-04-2023(online)].pdf 2023-04-27
29 201947050715-FORM 3 [27-04-2023(online)].pdf 2023-04-27
30 201947050715-FORM-26 [29-06-2023(online)].pdf 2023-06-29
31 201947050715-PatentCertificate10-08-2023.pdf 2023-08-10
32 201947050715-IntimationOfGrant10-08-2023.pdf 2023-08-10
33 201947050715-FORM-26 [28-12-2023(online)].pdf 2023-12-28
34 201947050715-CERTIFIED COPIES-CERTIFICATE U-S 72 147 & UR 133-2 [14-04-2025(online)].pdf 2025-04-14

Search Strategy

1 Search_HistoryE_16-03-2022.pdf
2 FER-2022-03-16-15-50-42E_16-03-2022.pdf

ERegister / Renewals

3rd: 31 Oct 2023

From 11/06/2020 - To 11/06/2021

4th: 31 Oct 2023

From 11/06/2021 - To 11/06/2022

5th: 31 Oct 2023

From 11/06/2022 - To 11/06/2023

6th: 31 Oct 2023

From 11/06/2023 - To 11/06/2024

7th: 05 Jun 2024

From 11/06/2024 - To 11/06/2025

8th: 29 May 2025

From 11/06/2025 - To 11/06/2026