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ORFADIN Drug Profile

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Orfadin is a drug marketed by Swedish Orphan and is included in two NDAs. It is available from one supplier. There is one patent protecting this drug.

This drug has fifteen patent family members in seventeen countries.

The generic ingredient in ORFADIN is nitisinone. One supplier is listed for this compound. Additional details are available on the nitisinone profile page.

Summary for Tradename: ORFADIN

Patents:1
Applicants:1
NDAs:2
Suppliers / Packagers: see list1
Drug Prices: :see details

Pharmacology for Tradename: ORFADIN

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-001Jan 18, 2002RXNo► subscribe► subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-004Jun 13, 2016RXYes► subscribe► subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-002Jan 18, 2002RXNo► subscribe► subscribe
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Expired Patents for Tradename: ORFADIN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-001Jan 18, 20025,006,158► subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-003Jan 18, 20025,006,158► subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-002Jan 18, 20025,550,165► subscribe
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International Patent Family for Tradename: ORFADIN

Country Document Number Estimated Expiration
San MarinoT201600097► subscribe
Australia2012273515► subscribe
Israel229677► 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 Certificates for Tradename: ORFADIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB05/030United Kingdom► subscribePRODUCT 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
00198Netherlands► subscribePRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201
C0024France► subscribePRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
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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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