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Generated: September 24, 2017
What are the generic sources for nitisinone and what is the scope of nitisinone patent protection?
Nitisinone is the generic ingredient in two branded drugs marketed by Swedish Orphan and Cycle Pharms Ltd, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.| Tradenames: | 2 |
| Patents: | 1 |
| Applicants: | 2 |
| NDAs: | 3 |
| Drug Master File Entries: see list | 2 |
| Suppliers / Packagers: see list | 2 |
| Bulk Api Vendors: see list | 66 |
| Clinical Trials: see list | 15 |
| Patent Applications: see list | 273 |
| Therapeutic Class: | Enzyme Replacements/Modifiers |
| Drug Prices: | see low prices |
| DailyMed Link: | nitisinone at DailyMed |
| Drug Class | Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor |
| Mechanism of Action | Hydroxyphenylpyruvate Dioxygenase Inhibitors |
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-001 | Jan 18, 2002 | ► Subscribe | ► Subscribe | ||||||||
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-003 | Jan 18, 2002 | ► Subscribe | ► Subscribe | ||||||||
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-002 | Jan 18, 2002 | ► Subscribe | ► Subscribe | ||||||||
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-002 | Jan 18, 2002 | ► Subscribe | ► Subscribe | ||||||||
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-001 | Jan 18, 2002 | ► Subscribe | ► Subscribe | ||||||||
Swedish Orphan | ORFADIN | nitisinone | CAPSULE;ORAL | 021232-003 | Jan 18, 2002 | ► Subscribe | ► Subscribe | ||||||||
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| European Patent Office | 2723320 | ► Subscribe | |||||||||||||
| Croatia | P20160286 | ► Subscribe | |||||||||||||
| Australia | 2012273515 | ► Subscribe | |||||||||||||
| Cyprus | 1117273 | ► Subscribe | |||||||||||||
| New Zealand | 618332 | ► Subscribe | |||||||||||||
| Japan | 6038132 | ► Subscribe | |||||||||||||
| Slovenia | 2723320 | ► Subscribe | |||||||||||||
| Mexico | 2013014567 | ► Subscribe | |||||||||||||
| Ukraine | 110979 | ► Subscribe | |||||||||||||
| Denmark | 2723320 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C0024 | France | ► Subscribe | PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221 | ||||||||||||
| 00198 | Netherlands | ► Subscribe | PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201 | ||||||||||||
| C/GB05/030 | United Kingdom | ► Subscribe | 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 | ||||||||||||
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Serving 500+ 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 verifification 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.
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