.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Claims for Patent: 8,865,688

« Back to Dashboard

Claims for Patent: 8,865,688

Title:Compositions and methods for treatment of bowel diseases with granulated mesalamine
Abstract: Disclosed are methods for treating gastrointestinal disorders, e.g., Crohn's disease, ulcerative colitis, and diverticular disease, with a granulated mesalamine formulation. Some formulations use granulated mesalamine in capsule form. Also included are methods to extend remission of ulcerative colitis by administration of a once-daily dosage of granulated mesalamine.
Inventor(s): Forbes; William (Raleigh, NC)
Assignee: Dr. Falk Pharma GmbH (DE)
Application Number:12/573,081
Patent Claims: 1. A method of maintaining the remission of ulcerative colitis in a subject comprising administering to the subject a granulated mesalamine formulation comprising four capsules each comprising 0.375 g of granulated mesalamine once per day in the morning, without food, wherein: said method maintains remission of ulcerative colitis in a subject for a period of at least 6 months of treatment; remission is defined as a DAI score of 0 or 1; the granulated mesalamine formulation is not administered with antacids; and wherein 85% to 90% of the mesalamine reaches the terminal ileum and colon.

2. The method of claim 1, wherein the granulated mesalamine formulation is a delayed and extended release formulation.

3. The method of claim 2, wherein delayed and extended release comprises first releasing mesalamine in the ileum and continuing to release mesalamine throughout the terminal ileum and colon.

4. The method of claim 1, wherein the granulated mesalamine formulation is administered for the maintenance of remission of ulcerative colitis in subjects 18 years of age and older.

5. The method of claim 1, further comprising advising the subject that subjects having hypersensitivity to salicylates, aminosalicylates, or any component of the granulated mesalamine formulation should not be administered the granulated mesalamine formulation.

6. The method of claim 1, further comprising advising the subject that when being administered granulated mesalamine formulation renal impairment may occur.

7. The method of claim 6, further comprising assessing the subject's renal function at one or more of the following: at the beginning of treatment, before initiating therapy, or periodically during therapy.

8. The method of claim 1, further comprising advising the subject that acute exacerbation of colitis symptoms can occur.

9. The method of claim 1, further comprising advising the subject that the granulated mesalamine formulation should be used with caution in subjects with renal disease.

10. The method of claim 1, further comprising monitoring the blood cell counts in geriatric subjects being administered the granulated mesalamine formulation.

11. The method of claim 1, further comprising advising the subject that there are adverse reactions associated with administration of the granulated mesalamine formulation.

12. The method of claim 11, wherein the adverse reactions comprise one or more of headache, diarrhea, upper abdominal pain, nausea, nasopharyngitis, flu or flu-like illness, and sinusitis.

13. The method of claim 1, further comprising advising the subject that the granulated mesalamine formulation is not expected to inhibit the metabolism of drugs that are substrates of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP3A4.

14. The method of claim 1, further comprising selecting a subject with a DAI score of 0 or 1 for maintaining remission of ulcerative colitis with granulated mesalamine.

15. The method of claim 1, wherein the mesalamine comprised in the formulation is released over approximately 7 hours.

16. A method of maintaining the remission of ulcerative colitis in a subject comprising advising the subject that granulated mesalamine should not be taken with antacids and administering to the subject granulated mesalamine formulation comprising four capsules each comprising 0.375 g of granulated mesalamine once per day in the morning, without food, wherein: said method maintains remission of ulcerative colitis in a subject for a period of at least 6 months of treatment; remission is defined as a DAI score of 0 or 1; the granulated mesalamine formulation is not administered with antacids; and wherein 85% to 90% of the mesalamine reaches the terminal ileum and colon.
« Back to Dashboard

For more information try a trial or see the database preview and plans and 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 verifification 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.

`abc