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Colesevelam 625 mg tablet?

See the DrugPatentWatch profile for Colesevelam

What is Colesevelam 625 mg tablet used for?

Colesevelam 625 mg tablets are a cholesterol-lowering medication that falls under the class of bile acid sequestrants. They are used primarily to reduce low-density lipoprotein (LDL) or "bad" cholesterol and triglycerides in the blood, helping to maintain healthy cholesterol levels in the body [1].

How does Colesevelam 625 mg tablet work?

Colesevelam works by binding to bile acids in the gut, preventing their reabsorption into the bloodstream. This results in the liver producing more bile acids to replace those lost, which in turn draws cholesterol from the bloodstream to synthesize the new bile acids, thus lowering the overall cholesterol levels in the body.

Why was Colesevelam 625 mg tablet approved?

The U.S. Food and Drug Administration (FDA) approved Colesevelam 625 mg tablets under the brand name Welchol in 2008 for the treatment of high cholesterol [2]. It is used in combination with a low-fat diet to help reduce cholesterol levels.

Is there any risk associated with Colesevelam 625 mg tablet?

Common side effects of Colesevelam 625 mg tablet include constipation, nausea, and flatulence [3]. Serious side effects may include liver damage, which can cause elevated liver enzymes, jaundice, and potentially lead to liver failure in rare cases. The risk is more pronounced in individuals with pre-existing liver conditions.

When was the patent set to expire?

According to DrugPatentWatch.com [4], the patent for Colesevelam HCl tablets, 625 mg, expired in July 2010. However, this information may have changed with the issuance of subsequent patents related to the drug, which may extend the exclusivity further.

The main sources used for this answer include:

[1] https://www.fda.gov/drugs/information-drug-class/cholesterol-lowering-medications
[2] https://www.accessdata.fda.gov/drugsatfdadocs/nda/2008/022184s000208BIOVAILWELCHOLT.pdf
[3] https://www.drugs.com/sfx/welchol-side-effects.html
[4] https://www.drugpatentwatch.com/Drugs/Welchol



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