Nitisinone Patent Expiration

Nitisinone is Used for managing hereditary tyrosinemia type 1 (HT-1) when combined with dietary restrictions of tyrosine and phenylalanine. It was first introduced by Swedish Orphan Biovitrum Ab Publ in its drug Orfadin on Jan 18, 2002. Other drugs containing Nitisinone are Harliku, Nityr. 6 different companies have introduced drugs containing Nitisinone.


Nitisinone Patents

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

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Nityr US10328029 Pharmaceutical composition Jan 05, 2035 Cycle
Orfadin US9301932 Liquid pharmaceutical composition comprising nitisinone Feb 28, 2033 Swedish Orphan
Orfadin US5550165 Pharmaceutical compositions for the treatment of hereditary tyosinemia type I Aug 27, 2013

(Expired)

Swedish Orphan



Nitisinone's Family Patents

Family Patents

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Nitisinone Generic API Manufacturers

Several generic applications have been filed for Nitisinone. The first generic version for Nitisinone was by Novitium Pharma Llc and was approved on Aug 26, 2019. And the latest generic version is by Eton Pharmaceuticals Inc and was approved on May 25, 2023.

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