You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 23, 2024

Claims for Patent: 10,406,199


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,406,199
Title:Lisinopril formulations
Abstract: Provided herein are stable lisinopril oral liquid formulations. Also provided herein are methods of using lisinopril oral liquid formulations for the treatment of certain diseases including hypertension, heart failure and acute myocardial infarction.
Inventor(s): Mosher; Gerold L. (Kansas City, MO), Miles; David W. (Kansas City, MO)
Assignee: SILVERGATE PHARMACEUTICALS, INC. (Greenwood Village, CO)
Application Number:16/295,482
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,406,199
Patent Claims: 1. A method of treating hypertension in a subject comprising administering to that subject a therapeutically effective amount of a stable oral liquid formulation, comprising: (i) about 1 mg/ml lisinopril or a pharmaceutically acceptable salt or solvate thereof; (ii) a sweetener; (iii) a buffer comprising citric acid and sodium citrate; (iv) a preservative selected from the group consisting of sodium benzoate, benzoic acid, sorbic acid, methylparaben, propylparaben, and salts thereof; and (v) water; wherein the formulation is stable at about 25.+-.5.degree. C. for at least 6 months.

2. The method of claim 1, wherein the lisinopril is lisinopril dihydrate.

3. The method of claim 1, wherein the pH of the formulation is between about 4 and about 5.2.

4. The method of claim 1, wherein the formulation is stable at about 25.+-.5.degree. C. for at least 24 months.

5. The method of claim 1, wherein the hypertension is primary (essential) hypertension.

6. The method of claim 1, wherein the hypertension is secondary hypertension.

7. The method of claim 1, wherein the subject has blood pressure values greater than or equal to 140/90 mmm Hg.

8. The method of claim 1, wherein the subject is elderly.

9. The method of claim 1, wherein the subject is a child.

10. The method of claim 1, wherein the formulation is further administered in combination with an agent selected from the group consisting of diuretics, beta blockers, alpha blockers, mixed alpha and beta blockers, calcium channel blockers, angiotensin II receptor antagonists, ACE inhibitors, aldosterone antagonists, and alpha-2 agonists.

11. A method of treating heart failure in a subject comprising administering to that subject a therapeutically effective amount of a stable oral liquid formulation, comprising: (i) about 1 mg/ml lisinopril or a pharmaceutically acceptable salt or solvate thereof; (ii) a sweetener; (iii) a buffer comprising citric acid and sodium citrate; (iv) a preservative selected from the group consisting of sodium benzoate, benzoic acid, sorbic acid, methylparaben, propylparaben, and salts thereof; and (v) water; wherein the formulation is stable at about 25.+-.5.degree. C. for at least 6 months.

12. The method of claim 11, wherein the lisinopril is lisinopril dihydrate.

13. The method of claim 11, wherein the pH of the formulation is between about 4 and about 5.2.

14. The method of claim 11, wherein the formulation is stable at about 25.+-.5.degree. C. for at least 24 months.

15. The method of claim 11, wherein the subject is not responding adequately to diuretics and digitalis.

16. A method of treating a hemodynamically stable subject within 24 hours of acute myocardial infarction comprising administering to that subject a therapeutically effective amount of a stable oral liquid formulation, comprising: (i) about 1 mg/ml lisinopril or a pharmaceutically acceptable salt or solvate thereof; (ii) a sweetener; (iii) a buffer comprising citric acid and sodium citrate; (iv) a preservative selected from the group consisting of sodium benzoate, benzoic acid, sorbic acid, methylparaben, propylparaben, and salts thereof; and (v) water; wherein the formulation is stable at about 25.+-.5.degree. C. for at least 6 months.

17. The method of claim 16, wherein the lisinopril is lisinopril dihydrate.

18. The method of claim 16, wherein the pH of the formulation is between about 4 and about 5.2.

19. The method of claim 16, wherein the formulation is stable at about 25.+-.5.degree. C. for at least 24 months.

20. The method of claim 16, wherein the formulation is further administered in combination with an agent selected from the group consisting of beta blockers, aspirin, and thrombolytics.

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.