NITISINONE Drug Patent Profile
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Which patents cover Nitisinone, and what generic alternatives are available?
Nitisinone is a drug marketed by Eton, Medunik, Novitium Pharma, and Torrent. and is included in four NDAs.
The generic ingredient in NITISINONE is nitisinone. There are two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Nitisinone
A generic version of NITISINONE was approved as nitisinone by NOVITIUM PHARMA on August 26th, 2019.
Summary for NITISINONE
| US Patents: | 0 |
| Applicants: | 4 |
| NDAs: | 4 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 125 |
| Clinical Trials: | 16 |
| Patent Applications: | 565 |
| Drug Prices: | Drug price information for NITISINONE |
| DailyMed Link: | NITISINONE at DailyMed |
US Patents and Regulatory Information for NITISINONE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Eton | NITISINONE | nitisinone | CAPSULE;ORAL | 216201-001 | May 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Medunik | NITISINONE | nitisinone | CAPSULE;ORAL | 212390-003 | May 26, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Eton | NITISINONE | nitisinone | CAPSULE;ORAL | 216201-004 | May 25, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Torrent | NITISINONE | nitisinone | CAPSULE;ORAL | 215908-001 | Jan 9, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Medunik | NITISINONE | nitisinone | CAPSULE;ORAL | 212390-004 | Apr 27, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for NITISINONE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| MendeliKABS Europe Ltd | Nitisinone MDK (previously Nitisinone MendeliKABS) | nitisinone | EMEA/H/C/004281 Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine. |
Withdrawn | yes | no | no | 2017-08-24 | |
| Cycle Pharmaceuticals (Europe) Ltd | Nityr | nitisinone | EMEA/H/C/004582 Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine. |
Authorised | yes | no | no | 2018-07-26 | |
| Swedish Orphan Biovitrum International AB | Orfadin | nitisinone | EMEA/H/C/000555 Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU). |
Authorised | no | no | no | 2005-02-21 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
