IP Library Granted Patent US 11,007,204
Granted Patent B2
US 11,007,204 · App. 16/171,100 · Granted May 18, 2021

Treating vitamin D insufficiency and deficiency with 25-hydroxyvitamin D2 and 25-hydroxyvitamin D3

Inventors: Charles W. Bishop (Miami Beach, FL); Keith H. Crawford (Lone Tree, CO); Eric J. Messner (Lake Forest, IL)
Assignee: OPKO RENAL, LLC
A61K31/593A61K9/00A61K9/0019A61K9/16A61K9/48A61K9/4808A61K9/4858A61K9/4866A61K9/4875A61K31/592A61K47/26
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Quick Facts
Patent No.
US 11,007,204
App. No.
16/171,100
Granted
May 18, 2021
Kind
B2
Abstract

Methods and compositions for treating 25-hydroxyvitamin D insufficiency and deficiency in a patient are described herein. The method includes orally administering to the patient a delayed, sustained release formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , or a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 , or it includes gradually administering to the patient a sterile intravenous formulation including a first ingredient selected from the group consisting of 25-hydroxyvitamin D 2 , 25-hydroxyvitamin D 3 , or a combination of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 .

Claims (18)

1. A method of treating or prophylactically treating a fracture in a subject, comprising administering to the subject a sustained-release formulation comprising one or both of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 .

2. The method of claim 1 , wherein the fracture is a non-traumatic fracture.

3. The method of claim 2 , wherein the fracture is a non-traumatic fracture of the spine or hip.

4. The method of claim 1 , wherein the formulation comprises 25-hydroxyvitamin D 3 .

5. The method of claim 4 , wherein formulation comprises an oral dosage form comprising the 25-hydroxyvitamin D 3 .

6. The method of claim 5 , wherein the oral dosage form is a capsule.

7. The method of claim 1 , wherein the sustained release formulation comprises 1 μg to 100 μg 25-hydroxyvitamin D.

8. The method of claim 7 , wherein the sustained release formulation comprises 1 μg to 50 μg 25-hydroxyvitamin D.

9. The method of claim 1 , wherein the subject has a renal disease, optionally, end stage renal disease (ESRD).

10. A method of slowing the development of a fracture in a subject, comprising administering to the subject a sustained-release formulation comprising one or both of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 .

11. The method of claim 9 , wherein the fracture is a non-traumatic fracture.

12. The method of claim 10 , wherein the fracture is a non-traumatic fracture of the spine or hip.

13. The method of claim 10 , wherein the formulation comprises 25-hydroxyvitamin D 3 .

14. The method of claim 10 , wherein formulation comprises an oral dosage form comprising the one or both of 25-hydroxyvitamin D 2 and 25-hydroxyvitamin D 3 .

15. The method of claim 13 , wherein the oral dosage form is a capsule.

16. The method of claim 9 , wherein the sustained release formulation comprises 1 μg to 100 μg 25-hydroxyvitamin D.

17. The method of claim 16 , wherein the sustained release formulation comprises 1 μg to 50 μg 25-hydroxyvitamin D.

18. The method of claim 10 , wherein the subject has a renal disease, optionally, end stage renal disease (ESRD).

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 26, 2019
From: BISHOP, CHARLES W.; CRAWFORD, KEITH H.; MESSNER, ERIC J.
To: PROVENTIV THERAPEUTICS, LLC
Reel/Frame 048443/0031 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 26, 2019
From: PROVENTIV THERAPEUTICS, LLC
To: OPKO HEALTH, INC.
Reel/Frame 048443/0073 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 26, 2019
From: OPKO HEALTH, INC.
To: OPKO RENAL, LLC
Reel/Frame 048443/0089 →
Continuity (6)
Continuation 15722757 · Oct 2, 2017
Continuation 14548275 · Nov 19, 2014
Continuation 13848982 · Mar 22, 2013
Division 12278053
Provisional Application 60764665 · Feb 3, 2006
Related Publication 20190060329A1 · Feb 28, 2019