Granted Patent
B2
US 12,350,246 · App. 18/435,678 · Granted Jul 8, 2025
Eflornithine and sulindac, fixed dose combination formulation
Inventors:
Patrick Shannon (Pensacola, FL); Roberto Carlos Bravo González (Binningen, CH); Jean Ducassou (Cestas, FR)
Assignee:
Cancer Prevention Pharmaceuticals, Inc.
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Abstract
Provided herein are fixed-dose combination formulations of a pharmaceutically effective amount of eflorithine together with a pharmaceutically effective amount of sulindac. Also provided are methods of use and of methods of manufacture of these formulations.
Claims (13)
1. A method of treating Lynch syndrome in a patient in need thereof, comprising administering to the patient a composition comprising a fixed dose combination in a single dosage unit of (a) about 375 mg eflornithine hydrochloride monohydrate and (b) about 75 mg of sulindac, wherein the composition further comprises magnesium stearate in an amount from about 1 to about 1.5 weight percent.
2. The method of claim 1 , wherein the composition is administered orally, intraarterially, intravenously, or topically.
3. The method of claim 1 , wherein the composition is administered orally.
4. The method of claim 1 , wherein the composition is administered every 12 hours.
5. The method of claim 1 , wherein the composition is administered every 24 hours.
6. The method of claim 1 , wherein the eflornithine hydrochloride monohydrate is a racemic mixture of its two enantiomers.
7. The method of claim 1 , wherein the composition further comprises an excipient.
8. The method of claim 7 , wherein the excipient is starch, colloidal silicon dioxide, or silicified microcrystalline cellulose.
9. The method of claim 7 , wherein the excipient is colloidal silicon dioxide.
10. The method of claim 7 , wherein the composition further comprises a second excipient.
11. The method of claim 10 , wherein the second excipient is silicified microcrystalline cellulose.
12. The method of claim 1 , wherein the amount of magnesium stearate is about 1.5 weight percent.
13. The method of claim 1 , wherein the composition is in the form of a capsule, tablet, mini-tablet, granule, pellet, solution, gel, cream, foam, or patch.
Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 24, 2025
From: SANOFI WINTHROP INDUSTRIE S.A.
To: CANCER PREVENTION PHARMACEUTICALS, INC.
Reel/Frame 073799/0085 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 24, 2025
From: DUCASSOU, JEAN
To: SANOFI WINTHROP INDUSTRIE
Reel/Frame 073020/0323 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 24, 2025
From: BRAVO GONZALEZ, ROBERTO CARLOS
To: TILLOTTS PHARMA AG
Reel/Frame 073799/0032 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 24, 2025
From: SHANNON, PATRICK
To: CANCER PREVENTION PHARMACEUTICALS, INC.
Reel/Frame 073800/0407 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 24, 2025
From: TILLOTTS PHARMA AG
To: CANCER PREVENTION PHARMACEUTICALS, INC.
Reel/Frame 073800/0690 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Nov 3, 2025
From: CREATIVE PLANNING BUSINESS ALLIANCE, LLC
To: USWM, LLC
Reel/Frame 072766/0028 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Oct 30, 2025
From: PANBELA THERAPEUTICS, INC.; PANBELA RESEARCH, INC.; CANCER PREVENTION PHARMACEUTICALS, INC.
To: CREATIVE PLANNING BUSINESS ALLIANCE LLC
Reel/Frame 072735/0859 →
Priority Claims (2)
EP 16306429
· Oct 28, 2016
· regional
EP 16306430
· Oct 28, 2016
· regional
Continuity (6)
Continuation
15771484
Provisional Application
62358698
· Jul 6, 2016
Provisional Application
62248810
· Oct 30, 2015
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