DrugPatentWatch Database Preview➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing
« Back to Dashboard
Nitisinoneis 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 twenty-eight patent family members in twenty-three countries.
There are two drug master file entries for nitisinone. Three suppliers are listed for this compound. There is one tentative approval for this compound.
Recent Clinical Trials for nitisinone
Identify potential brand extensions & 505(b)(2) entrants
|Cycle Pharmaceuticals Ltd.||Phase 1|
Generic filers with tentative approvals for NITISINONE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for nitisinone
|Drug Class||4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor |
|Mechanism of Action||Hydroxyphenylpyruvate Dioxygenase Inhibitors |
Cytochrome P450 2C9 Inhibitors
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Novitium Pharma||NITISINONE||nitisinone||CAPSULE;ORAL||211041-002||Aug 26, 2019||AB||RX||No||No||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||CAPSULE;ORAL||021232-001||Jan 18, 2002||AB||RX||Yes||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|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|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|0591275||05C0024||France||Start Trial||PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221|
|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|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
Make Better Decisions: Try a trial or see plans & pricing
Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.