Sepiapterin Patent Expiration

Sepiapterin was first introduced by Ptc Therapeutics Inc in its drug Sephience on Jul 28, 2025.


Sepiapterin Patents

Given below is the list of patents protecting Sepiapterin, 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
Sephience US12257252 Compositions And Methods For Increasing Tetrahydrobiopterin Plasma Exposure Mar 06, 2042 Ptc Therap
Sephience US11752154 Pharmaceutical Compositions Comprising Sepiapterin And Uses Thereof Sep 04, 2038 Ptc Therap
Sephience US12213982 Pharmaceutical Compositions Comprising Sepiapterin And Uses Thereof Sep 04, 2038 Ptc Therap
Sephience US11072614 Polymorphs Of Sepiapterin And Salts Thereof Apr 16, 2038 Ptc Therap



Sepiapterin's Family Patents

Family Patents

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Clinical Trials

Recent Clinical Trials on Sepiapterin:

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
A Study of Sepiapterin in Participants With Phenylketonuria (PKU) PTC Therapeutics NA RECRUITING
(Aug 1, 2026)
PHASE3


Sepiapterin Generic API Manufacturers

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