IP Library Granted Patent US 10,675,400
Granted Patent B2
US 10,675,400 · App. 15/193,815 · Granted Jun 9, 2020

Prefilled syringes and kits thereof

Inventors: Paul K. Wotton (Newtown, PA); Peter L. Sadowski (Woodbury, MN); Kaushik J. Dave (Ewing, NJ); Dominic P. Capone (Abington, PA)
Assignee: Antares Pharma, Inc.
A61M5/002A61K9/0053A61K31/519A61M5/178
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Quick Facts
Patent No.
US 10,675,400
App. No.
15/193,815
Granted
Jun 9, 2020
Kind
B2
Abstract

The present disclosure relates, in part, to a kit including at least two prefilled syringes. The first prefilled syringe includes a dose of a hazardous agent in a first volume of a pharmaceutical composition comprising a pharmaceutically acceptable solvent.

Claims (49)

1. A medical kit comprising:

a first kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the at least two prefilled syringes, wherein:

the at least two prefilled syringes of the first kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutical acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of about 7.5 mg to about 25 mg;

wherein a volume of the pharmaceutical composition in the at least two prefilled syringes of the first kit is greater than 0.01 ml but less than or equal to about 1 ml and a concentration of the methotrexate in a first prefilled syringe of the at least two prefilled syringes is 25 mg/ml;

wherein the volume of the pharmaceutical composition in each of the at least two prefilled syringes is substantially the same; and

wherein the concentration of the methotrexate in one of the at least two prefilled syringes is different than the concentration of the methotrexate in another of the at least two prefilled syringes.

2. The medical kit of claim 1 , further comprising:

a second kit and a third kit, each of the second kit and the third kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the at least two prefilled syringes of each of the second kit and the third kit, wherein:

the at least two prefilled syringes of each of the second kit and the third kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutical acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of about 7.5 mg to about 25 mg;

wherein a volume of the pharmaceutical composition in one of the at least two prefilled syringes of each of the second kit and the third kit is greater than 0.01 ml but less than or equal to about 1 ml and a concentration of the methotrexate in a first prefilled syringe of the at least two prefilled syringes of each of the second kit and the third is 25 mg/ml; and

wherein the volume of the pharmaceutical composition in one of the at least two prefilled syringes of the second kit is different than the volume of the pharmaceutical composition in one of the at least two prefilled syringes of the first kit, and the volume of the pharmaceutical composition in one of the at least two prefilled syringes of the third kit is different than the volume of the pharmaceutical composition in one of the at least two prefilled syringes of the first and second kits.

3. The medical kit of claim 2 , further comprising:

a fourth kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the at least two prefilled syringes, wherein:

the at least two prefilled syringes of the fourth kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutical acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of from about 7.5 mg to about 25 mg;

wherein a volume of the pharmaceutical composition in the at least two prefilled syringes of the fourth kit is greater than 0.01 ml but less than or equal to about 1 ml and a concentration of the methotrexate in one of the at least two prefilled syringes of the fourth kit is 25 mg/ml;

wherein the fourth kit does not include an autoinjector; and

wherein the volume of the pharmaceutical composition in one of the at least two prefilled syringes of the fourth kit is different than the volume of the pharmaceutical composition in one of the at least two prefilled syringes of the first kit, second kit, and third kit.

4. The medical kit of claim 3 , further comprising:

a fifth kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the syringes, wherein:

the prefilled syringes of the fifth kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutical acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of from about 7.5 mg to about 25 mg;

wherein a volume of the pharmaceutical composition in the at least two prefilled syringes of the fifth kit is greater than 0.01 ml but less than or equal to about 1 ml and a concentration of the methotrexate in the at least two prefilled syringes of the fifth kit is 25 mg/ml;

wherein the fifth kit does not include an autoinjector; and

wherein the volume of the pharmaceutical composition of one of the at least two prefilled syringes of the fifth kit is different than the volume of the pharmaceutical composition of one of the at least two prefilled syringes of the first kit, second kit, third kit, and fourth kit.

5. The medical kit according to claim 1 , wherein the dose of methotrexate in the at least two prefilled syringes of the first kit is selected from the group consisting of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg.

6. The medical kit according to claim 2 , wherein the dose of methotrexate in the at least two prefilled syringes in each of the second kit and the third kit is selected from the group consisting of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg.

7. The medical kit according to claim 3 , wherein the dose of methotrexate in the at least two prefilled syringes of the fourth kit is selected from the group consisting of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg.

8. The medical kit according to claim 4 , wherein the dose of methotrexate in the at least two prefilled syringes of the fifth kit is selected from the group consisting of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg.

9. The medical kit according to claim 1 , wherein the volume of the pharmaceutical composition in the at least two prefilled syringes of the first kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

10. The medical kit according to claim 2 , wherein the volume of the pharmaceutical composition in the at least two prefilled syringes of each of the second kit and the third kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

11. The medical kit according to claim 3 , wherein the volume of the pharmaceutical composition in the at least two prefilled syringes of the fourth kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

12. The medical kit according to claim 4 , wherein the volume of the pharmaceutical composition of the at least two prefilled syringes of the fifth kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

13. The medical kit according to claim 12 , wherein the volume of the pharmaceutical composition of the at least two prefilled syringes of the first kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

14. The medical kit according to claim 13 , wherein the volume of the pharmaceutical composition of the at least two prefilled syringes of the second kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

15. The medical kit according to claim 14 , wherein the volume of the pharmaceutical composition of the at least two prefilled syringes of the third kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

16. The medical kit according to claim 15 , wherein the volume of the pharmaceutical composition of the at least two prefilled syringes of the fourth kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

17. A method to provide methotrexate comprising:

providing a first kit comprising at least two prefilled syringes configured to deliver methotrexate subcutaneously to a patient in need thereof and instructions for the use of the syringes, wherein:

the at least two prefilled syringes of the first kit include a pharmaceutical composition comprising a dose of methotrexate in a volume of a pharmaceutical acceptable solvent that includes water or ethanol,

wherein the dose of methotrexate is in a range of about 7.5 mg to about 25 mg;

wherein the a volume of the pharmaceutical composition in the at least two prefilled syringes of the first kit is greater than 0.01 ml but less than or equal to about 1 ml and a concentration of the methotrexate in a first prefilled syringe of the at least two prefilled syringes is 25 mg/ml;

wherein the first kit does not include an autoinjector;

wherein the volume of the pharmaceutical composition in each of the at least two prefilled syringes is substantially the same; and

wherein the concentration of the methotrexate in one of the at least two prefilled syringes is different than the concentration of the methotrexate in another of the at least two prefilled syringes.

18. The method according to claim 17 , wherein the dose of methotrexate in the at least two prefilled syringes of the first kit is selected from the group consisting of 7.5 mg, 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, and 25 mg.

19. The method according to claim 17 , wherein the volume of the pharmaceutical composition in the at least two prefilled syringes of the first kit is selected from 0.3 ml, 0.4 ml, 0.6 ml, 0.8 ml and 1.0 ml.

Assignments (4)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 26, 2026
From: ASSERTIO SPECIALTY PHARMACEUTICALS, LLC
To: COSETTE PHARMACEUTICALS, INC.
Reel/Frame 075777/0714 →
CHANGE OF NAME Recorded Aug 13, 2025
From: OTTER PHARMACEUTICALS, LLC
To: ASSERTIO SPECIALTY PHARMACEUTICALS, LLC
Reel/Frame 072435/0516 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 27, 2022
From: ANTARES PHARMA, INC.
To: OTTER PHARMACEUTICALS, LLC
Reel/Frame 059748/0930 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 30, 2022
From: WOTTON, PAUL K.; SADOWSKI, PETER L.; DAVE, KAUSHIK J.; CAPONE, DOMINIC P.
To: ANTARES PHARMA, INC.
Reel/Frame 059449/0472 →
Continuity (4)
Continuation 14678449 · Apr 3, 2015
Continuation PCTUS2014024530 · Mar 12, 2014
Provisional Application 61778398 · Mar 12, 2013
Related Publication 20160303311A1 · Oct 20, 2016