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Last Updated: June 27, 2022

XENICAL Drug Patent Profile


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When do Xenical patents expire, and what generic alternatives are available?

Xenical is a drug marketed by Cheplapharm and is included in one NDA.

The generic ingredient in XENICAL is orlistat. There are twelve drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the orlistat profile page.

Drug patent expirations by year for XENICAL
Drug Prices for XENICAL

See drug prices for XENICAL

Recent Clinical Trials for XENICAL

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Cleveland ClinicPhase 4
Khoo Teck Puat HospitalPhase 4
Pennington Biomedical Research CenterN/A

See all XENICAL clinical trials

Pharmacology for XENICAL

US Patents and Regulatory Information for XENICAL

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for XENICAL

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

International Patents for XENICAL

See the table below for patents covering XENICAL around the world.

Country Patent Number Title Estimated Expiration
Australia 2947884 See Plans and Pricing
Poland 330972 See Plans and Pricing
Slovenia 0921796 See Plans and Pricing
Mexico 9203633 DERIVADOS DE LEUCINA Y COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN. See Plans and Pricing
Morocco 24466 See Plans and Pricing
New Zealand 208521 LEUCINE DERIVATIVES AND PHARMACEUTICAL COMPOSITIONS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for XENICAL

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0129748 98C0042 Belgium See Plans and Pricing PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
0129748 SPC/GB98/044 United Kingdom See Plans and Pricing PRODUCT NAME: ORLISTAT; REGISTERED: UK EU/1/98/071/001 19980729; UK EU/1/98/071/002 19980729; UK EU/1/98/071/003 19980729; UK EO/1/98/071/004 19980729; UK EU/1/98/071/005 19980729; UK EU/1/98/071/006 19980729
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Moodys
Boehringer Ingelheim
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