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Last Updated: August 9, 2020

DrugPatentWatch Database Preview

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. One supplier is listed for this compound.

Recent Clinical Trials for ORLISTAT

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

SponsorPhase
University of MinnesotaPhase 2
Gangnam Severance HospitalN/A
Emory UniversityPhase 1/Phase 2

See all ORLISTAT clinical trials

Pharmacology for ORLISTAT
Paragraph IV (Patent) Challenges for ORLISTAT
Tradename Dosage Ingredient NDA Submissiondate
ALLI CAPSULE;ORAL orlistat 021887 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   Start Trial   Start Trial   Start Trial
Glaxosmithkline Cons ALLI orlistat CAPSULE;ORAL 021887-001 Feb 7, 2007 OTC Yes Yes   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Cheplapharm XENICAL orlistat CAPSULE;ORAL 020766-001 Apr 23, 1999   Start Trial   Start Trial
Cheplapharm XENICAL orlistat CAPSULE;ORAL 020766-001 Apr 23, 1999   Start Trial   Start Trial
Glaxosmithkline Cons ALLI orlistat CAPSULE;ORAL 021887-001 Feb 7, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Mallinckrodt
Colorcon
Moodys
Baxter
Boehringer Ingelheim

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