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Last Updated: April 13, 2024

ALLI Drug Patent Profile

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

Alli is a drug marketed by Haleon Us Holdings and is included in one NDA.

The generic ingredient in ALLI is orlistat. There are twelve drug master file entries for this compound. Three 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
Haleon Us Holdings ALLI orlistat CAPSULE;ORAL 021887-001 Feb 7, 2007 OTC Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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, ≥ 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

Supplementary Protection Certificates for ALLI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0129748 98C0042 Belgium ⤷  Try a Trial PRODUCT NAME: ORLISTAT; REGISTRATION NO/DATE: EU/1/98/071/001 19980729
0129748 SPC/GB98/044 United Kingdom ⤷  Try a Trial 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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