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Last Updated: August 14, 2022

Orlistat - Generic Drug Details


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What are the generic sources for orlistat and what is the scope of freedom to operate?

Orlistat is the generic ingredient in two branded drugs marketed by Glaxosmithkline Cons and Cheplapharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for orlistat. Two suppliers are listed for this compound.

Summary for orlistat
Recent Clinical Trials for orlistat

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SponsorPhase
University of MinnesotaPhase 3
Shandong New Time Pharmaceutical Co., LTDN/A
The Cleveland ClinicPhase 4

See all orlistat clinical trials

Pharmacology for orlistat
Paragraph IV (Patent) Challenges for ORLISTAT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ALLI Capsules orlistat 60 mg 021887 1 2010-09-08

US Patents and Regulatory Information for orlistat

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cheplapharm XENICAL orlistat CAPSULE;ORAL 020766-001 Apr 23, 1999 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Glaxosmithkline Cons ALLI orlistat CAPSULE;ORAL 021887-001 Feb 7, 2007 OTC Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for orlistat

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Glaxosmithkline Cons ALLI orlistat CAPSULE;ORAL 021887-001 Feb 7, 2007 See Plans and Pricing See Plans and Pricing
Cheplapharm XENICAL orlistat CAPSULE;ORAL 020766-001 Apr 23, 1999 See Plans and Pricing See Plans and Pricing
Cheplapharm XENICAL orlistat CAPSULE;ORAL 020766-001 Apr 23, 1999 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for orlistat

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
GlaxoSmithKline (Ireland) Limited Alli (previously Orlistat GSK) orlistat EMEA/H/C/000854
Alli is indicated for weight loss in adults who are overweight (body mass index, BMI, ≥ 28 kg/m2) and should be taken in conjunction with a mildly hypocaloric, lower-fat diet.
Authorised no no no 2007-07-22
CHEPLAPHARM Arzneimittel GmbH Xenical orlistat EMEA/H/C/000154
Xenical is indicated in conjunction with a mildly hypocaloric diet for the treatment of obese patients with a body mass index (BMI) greater or equal to 30 kg/m2, or overweight patients (BMI > 28 kg/m2) with associated risk factors.Treatment with orlistat should be discontinued after 12 weeks if patients have been unable to lose at least 5% of the body weight as measured at the start of therapy.
Authorised no no no 1998-07-29
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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