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Last Updated: October 1, 2022

ALLI Drug Patent Profile


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Which patents cover Alli, and what generic alternatives are available?

Alli is a drug marketed by Glaxosmithkline Cons and is included in one NDA.

The generic ingredient in ALLI 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.

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

US Patents and Regulatory Information for ALLI

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

EU/EMA Drug Approvals for ALLI

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, ‚Č• 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 ALLI

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

Country Patent Number Title Estimated Expiration
Taiwan 533082 See Plans and Pricing
Uruguay 24875 COMPOSICIONES FARMAC√ČUTICAS CONTENIENDO TETRAHIDROLIPSTATINA See Plans and Pricing
South Africa 9800746 See Plans and Pricing
Australia 2947884 See Plans and Pricing
Russian Federation 2170579 TETRAHYDROLIPSTATIN-CONTAINING COMPOSITIONS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ALLI

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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