IP Library › Granted Patent US 10,568,937
Granted Patent B2
US 10,568,937 · App. 16/092,587 · Granted Feb 25, 2020

Formulations of abaloparatide, transdermal patches thereof, and uses thereof

Inventors: Gary Hattersley (Stow, MA); Alan Harris (New York City, NY); Jamal Saeh (Belmont, MA); Ehab Hamed (Lexington, MA); Kenneth Brown (St. Paul, MN); Daniel Dohmeier (St. Paul, MN); Joan Moseman (St. Paul, MN); Ying Zhang (Woodbury, MN); Lisa Dick (St. Paul, MN)
Assignees: Radius Health, Inc.; 3M Innovative Properties Company
A61K38/29A61K9/0014A61K9/0021A61K9/703A61K33/06A61K33/30A61K47/10A61P19/02A61P19/10
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Quick Facts
Patent No.
US 10,568,937
App. No.
16/092,587
Granted
Feb 25, 2020
Kind
B2
Abstract

Disclosed are abaloparatide formulations for transdermal delivery of a therapeutically effective amount of abaloparatide, as well as transdermal patches prepared using these formulations, methods of preparing the disclosed formulations and patches, and methods of using these formulations and patches to treat osteoporosis, osteopenia, osteoarthritis, and/or bone fracture, improve bone mineral density (BMD), improve trabecular bone score (TBS), and treat, prevent, and/or reduce bone fractures.

Claims (7)

1. A method of accelerating, or facilitating fracture healing, or treating fractures comprising the administration of a patch comprising a plurality of microprojections covered at least in part by a formulation comprising abaloparatide and one or more excipients selected from the group consisting of Zn 2+ salts, Mg 2+ salts, and Ca 2+ salts.

2. The method according to claim 1 , wherein said excipients comprise a Zn 2+ salt.

3. The method according to claim 1 wherein the molar ratio of said excipients to abaloparatide is from 0.1 to 3.0.

4. The method according to claim 1 wherein the molar ratio of said excipients to abaloparatide is from 1.5 to 2.5.

5. The method according to claim 1 wherein the patch formulation contains from 2%-10% w/w of said excipient.

6. The method according to claim 1 wherein the patch formulation contains from 5%-7% w/w of said excipient.

7. The method according to claim 1 wherein the patch comprises abaloparatide in an amount between 200-450 μg.

Assignments (18)
RELEASE OF SECURITY INTEREST Recorded Oct 30, 2025
From: WILMINGTON TRUST, NATIONAL ASSOCIATION
To: RADIUS HEALTH, INC.
Reel/Frame 073278/0396 →
SECURITY INTEREST Recorded Dec 14, 2022
From: KINDEVA DRUG DELIVERY L.P.
To: JPMORGAN CHASE BANK, N.A., AS COLLATERAL AGENT
Reel/Frame 062122/0618 →
TERMINATION AND RELEASE OF SECURITY INTEREST IN PATENT COLLATERAL RECORDED AT R/F 053586/0715 Recorded Dec 12, 2022
From: MIDCAP FINANCIAL TRUST, AS ADMINISTRATIVE AGENT
To: KINDEVA DRUG DELIVERY L.P.
Reel/Frame 062115/0707 →
SECURITY INTEREST Recorded Aug 16, 2022
From: RADIUS HEALTH, INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 061179/0001 →
RELEASE OF SECURITY INTEREST Recorded Aug 15, 2022
From: MIDCAP FUNDING IV TRUST
To: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.
Reel/Frame 061176/0914 →
RELEASE OF SECURITY INTEREST Recorded Aug 15, 2022
From: MIDCAP FINANCIAL TRUST
To: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.
Reel/Frame 061176/0938 →
REAFFIRMATION, JOINDER & AMENDMENT TO SECURITY AGREEMENT (TERM) Recorded Mar 17, 2021
From: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.; RADIUS HEALTH VENTURES, INC.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 055632/0017 →
REAFFIRMATION, JOINDER & AMENDMENT TO SECURITY AGREEMENT (REVOLVING) Recorded Mar 17, 2021
From: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.; RADIUS HEALTH VENTURES, INC.
To: MIDCAP FUNDING IV TRUST, AS AGENT
Reel/Frame 055632/0316 →
SECURITY INTEREST Recorded Aug 24, 2020
From: KINDEVA DRUG DELIVERY L.P.
To: MIDCAP FINANCIAL TRUST, AS ADMINISTRATIVE AGENT
Reel/Frame 053586/0715 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 24, 2020
From: 3M INNOVATIVE PROPERTIES COMPANY
To: KINDEVA DRUG DELIVERY L.P.
Reel/Frame 053586/0388 →
ASSIGNMENT OF INTELLECTUAL PROPERTY SECURITY AGREEMENT Recorded Jul 6, 2020
From: MIDCAP FINANCIAL TRUST
To: MIDCAP FUNDING IV TRUST
Reel/Frame 053131/0465 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 2, 2020
From: 3M COMPANY; 3M INNOVATIVE PROPERTIES COMPANY
To: KINDEVA DRUG DELIVERY L.P.
Reel/Frame 052818/0234 →
SECURITY INTEREST (REVOLVING) Recorded Jan 15, 2020
From: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 051618/0758 →
SECURITY INTEREST (TERM) Recorded Jan 15, 2020
From: RADIUS HEALTH, INC.; RADIUS PHARMACEUTICALS, INC.
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 051618/0200 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 9, 2019
From: BROWN, KENNETH; DOHMEIER, DANIEL; MOSEMAN, JOAN; ZHANG, YING; DICK, LISA
To: 3M INNOVATIVE PROPERTIES COMPANY
Reel/Frame 051215/0450 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Mar 19, 2019
From: HATTERSLEY, GARY; HARRIS, ALAN; SAEH, JAMAL; HAMED, EHAB
To: RADIUS HEALTH, INC.
Reel/Frame 048638/0520 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 1, 2019
From: RADIUS HEALTH, INC.
To: 3M INNOVATIVE PROPERTIES COMPANY
Reel/Frame 048216/0102 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 31, 2019
From: HATTERSLEY, GARY; HARRIS, ALAN; SAEH, JAMAL; HAMED, EHAB
To: RADIUS HEALTH, INC.
Reel/Frame 048202/0717 →