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. Another drug containing Nitisinone is 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..


1. ETON

Eton Pharmaceuticals Inc has filed for 4 different strengths of generic version for Nitisinone. Given below are the details of the strengths of this generic introduced by Eton.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG capsule Prescription ORAL AB May 25, 2023
5MG capsule Prescription ORAL AB May 25, 2023
10MG capsule Prescription ORAL AB May 25, 2023
20MG capsule Prescription ORAL AB May 25, 2023


Manufacturing Plant Locations
New

Eton's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Eton as present at those locations.

Country City Firm Name
United States
Deer Park Eton Pharmaceuticals, Inc.




2. MEDUNIK

Medunik Canada Inc has filed for 4 different strengths of generic version for Nitisinone. Given below are the details of the strengths of this generic introduced by Medunik.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG capsule Prescription ORAL AB May 26, 2022
5MG capsule Prescription ORAL AB May 26, 2022
10MG capsule Prescription ORAL AB May 26, 2022
20MG capsule Prescription ORAL AB Apr 27, 2023






3. NOVITIUM PHARMA

Novitium Pharma Llc has filed for 3 different strengths of generic version for Nitisinone. Given below are the details of the strengths of this generic introduced by Novitium Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG capsule Prescription ORAL AB Aug 26, 2019
5MG capsule Prescription ORAL AB Aug 26, 2019
10MG capsule Prescription ORAL AB Aug 26, 2019


Manufacturing Plant Locations
New

Novitium Pharma's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Novitium Pharma as present at those locations.

Country City Firm Name
United States
East Windsor Novitium Pharma LLC




4. TORRENT

Torrent Pharma Inc has filed for 4 different strengths of generic version for Nitisinone. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
20MG capsule Discontinued ORAL N/A Jan 9, 2023
2MG capsule Discontinued ORAL N/A Jan 9, 2023
5MG capsule Discontinued ORAL N/A Jan 9, 2023
10MG capsule Discontinued ORAL N/A Jan 9, 2023


Manufacturing Plant Locations
New

Torrent's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Torrent as present at those locations.

Country City Firm Name
India
Gandhi Nagar Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
Pithampur Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Bharuch Torrent Pharmaceuticals Limited
United States
Basking Ridge Torrent Pharma Inc.
Kalamazoo Torrent Pharma Inc.