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
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
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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 |
| |||
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 |
| |||
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 |
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| United States |
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