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Nitisinone - Generic Drug Details
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What are the generic sources for nitisinone and what is the scope of freedom to operate?
Nitisinone
is the generic ingredient in three branded drugs marketed by Novitium Pharma, Swedish Orphan, and Cycle Pharms Ltd, and is included in four NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Nitisinone has thirty-four patent family members in twenty-five countries.
There are two drug master file entries for nitisinone. Three suppliers are listed for this compound.
Summary for nitisinone
International Patents: | 34 |
US Patents: | 2 |
Tradenames: | 3 |
Applicants: | 3 |
NDAs: | 4 |
Drug Master File Entries: | 2 |
Suppliers / Packagers: | 3 |
Bulk Api Vendors: | 105 |
Clinical Trials: | 16 |
Patent Applications: | 782 |
What excipients (inactive ingredients) are in nitisinone? | nitisinone excipients list |
DailyMed Link: | nitisinone at DailyMed |
Recent Clinical Trials for nitisinone
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Sponsor | Phase |
---|---|
Sutphin Drugs | N/A |
Parexel | Phase 1 |
Cycle Pharmaceuticals Ltd. | Phase 1 |
Pharmacology for nitisinone
Drug Class | 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor |
Mechanism of Action | Hydroxyphenylpyruvate Dioxygenase Inhibitors Cytochrome P450 2C9 Inhibitors |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cycle Pharms Ltd | NITYR | nitisinone | TABLET;ORAL | 209449-003 | Jul 26, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
Novitium Pharma | NITISINONE | nitisinone | CAPSULE;ORAL | 211041-003 | Aug 26, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Novitium Pharma | NITISINONE | nitisinone | CAPSULE;ORAL | 211041-001 | Aug 26, 2019 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-004 | Jun 13, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-002 | Jan 18, 2002 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
Swedish Orphan | ORFADIN | nitisinone | SUSPENSION;ORAL | 206356-001 | Apr 22, 2016 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Cycle Pharms Ltd | NITYR | nitisinone | TABLET;ORAL | 209449-002 | Jul 26, 2017 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for nitisinone
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-001 | Jan 18, 2002 | Start Trial | Start Trial |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-002 | Jan 18, 2002 | Start Trial | Start Trial |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-003 | Jan 18, 2002 | Start Trial | Start Trial |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-001 | Jan 18, 2002 | Start Trial | Start Trial |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-002 | Jan 18, 2002 | Start Trial | Start Trial |
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-003 | Jan 18, 2002 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for nitisinone
Country | Patent Number | Estimated Expiration |
---|---|---|
Cyprus | 1117273 | Start Trial |
Russian Federation | 2014101990 | Start Trial |
Poland | 2723320 | Start Trial |
Japan | 2014517067 | Start Trial |
Australia | 2012273515 | Start Trial |
Russian Federation | 2605301 | Start Trial |
European Patent Office | 3089740 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for nitisinone
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0591275 | C300198 | Netherlands | Start Trial | PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201 |
0591275 | SPC/GB05/030 | United Kingdom | Start Trial | PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221 |
0591275 | 05C0024 | France | Start Trial | PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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