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Details for Generic Name: orlistat

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Orlistat is the generic ingredient in two branded drugs marketed by Glaxosmithkline Cons and Hoffmann La Roche, and is included in two NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-eight patent family members in thirty-three countries.

There are nine drug master file entries for orlistat. Three suppliers are listed for this compound.

Summary for Generic Name: orlistat

Drug Master File Entries: see list9
Suppliers / Packaging: see list13

Pharmacology for Ingredient: orlistat

Clinical Trials for: orlistat

Meta-analysis of Orlistat Laboratory Data From Placebo-controlled Clinical Trials
Status: Completed Condition: Obesity

Study of Fat Malabsorption by Lipiblock Versus Xenical
Status: Completed Condition: Obesity

Orlistat Induced Modulation on the Fatty Acid Composition in Obese Females
Status: Completed Condition: Overweight

Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia
Status: Not yet recruiting Condition: Type 1 Hyperlipoproteinemia

Adding Guided Self-Help Group Therapy to the Alli Weight Loss Program in Treating Binge Eating Disorder
Status: Completed Condition: Overweight; Eating Disorders

A Study to Assess the Pharmacologic Equivalence of Two Orlistat Dosage Forms
Status: Completed Condition: Overweight

The Effect of Modified Sham Feeding With Orlistat in Overweight and Obese Subjects
Status: Withdrawn Condition: Overweight

Metformin Versus Orlistat in Obese Polycystic Ovary Syndrome (PCOS) Patients
Status: Completed Condition: Obesity

A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Status: Completed Condition: Diabetes Mellitus; Obesity

Double-Blind, Multi-Center, Randomized Study to Assess the Efficacy and Safety of Velneperit (S-2367) and Orlistat Administered Individually or Combined With a Reduced Calorie Diet (RCD) in Obese Subjects
Status: Completed Condition: Obesity

Courtesy of
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hoffmann La Roche
CAPSULE;ORAL020766-001Apr 23, 1999RXYes6,004,996*PED<disabled>Y<disabled>
Glaxosmithkline Cons
CAPSULE;ORAL021887-001Feb 7, 2007OTCYes6,004,996<disabled>Y <disabled>
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International Patent Family for Ingredient: orlistat

Country Document Number Publication Date
Israel126902Sep 22, 1999
CroatiaP980057Aug 31, 2001
Poland330972Jun 21, 1999
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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