Orlistat Patent Expiration

Orlistat was first introduced by Cheplapharm Arzneimittel Gmbh in its drug Xenical on Apr 23, 1999. Another drug containing Orlistat is Alli. 2 different companies have introduced drugs containing Orlistat.


Orlistat Patents

Given below is the list of patents protecting Orlistat, along with the drug name that holds that patent and the company name owning that drug.

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Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Xenical US6004996

(Pediatric)

Tetrahydrolipstatin containing compositions Jul 06, 2018

(Expired)

Cheplapharm
Alli US6004996 Tetrahydrolipstatin containing compositions Jan 06, 2018

(Expired)

Haleon Us Holdings
Xenical US6004996 Tetrahydrolipstatin containing compositions Jan 06, 2018

(Expired)

Cheplapharm



Orlistat's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Orlistat:

Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.

Title Lead Sponsor Collaborators Status Phases
Clinical Trials
Long Term Efficacy and Safety of Orlistat for Type 1 Hyperlipoproteinemia University of Texas Southwestern Medical Center NA RECRUITING
(Jul 1, 2026)
PHASE2


Orlistat Generic API Manufacturers

Given below is the list of companies who have filed for Orlistat generic, along with the locations of their manufacturing plants worldwide.