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Serving 500+ biopharmaceutical companies globally:

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Generated: September 24, 2017

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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 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.

Nitisinone has twenty patent family members in twenty countries.

There are two drug master file entries for nitisinone. Two suppliers are listed for this compound.

Summary for Generic Name: nitisinone

Tradenames:2
Patents:1
Applicants:2
NDAs:3
Drug Master File Entries: see list2
Suppliers / Packagers: see list2
Bulk Api Vendors: see list66
Clinical Trials: see list15
Patent Applications: see list273
Therapeutic Class:Enzyme Replacements/Modifiers
Drug Prices:see low prices
DailyMed Link:nitisinone at DailyMed

Pharmacology for Ingredient: nitisinone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Swedish Orphan
ORFADIN
nitisinone
SUSPENSION;ORAL206356-001Apr 22, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-002Jan 18, 2002RXYesNo► Subscribe► Subscribe► Subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-004Jun 13, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-003Jan 18, 2002RXYesYes► Subscribe► Subscribe► Subscribe
Cycle Pharms Ltd
NITYR
nitisinone
TABLET;ORAL209449-002Jul 26, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Cycle Pharms Ltd
NITYR
nitisinone
TABLET;ORAL209449-001Jul 26, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-001Jan 18, 2002RXYesNo► Subscribe► Subscribe► Subscribe
Cycle Pharms Ltd
NITYR
nitisinone
TABLET;ORAL209449-003Jul 26, 2017RXYesYes► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: nitisinone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-001Jan 18, 2002► Subscribe► Subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-003Jan 18, 2002► Subscribe► Subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-002Jan 18, 2002► Subscribe► Subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-002Jan 18, 2002► Subscribe► Subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-001Jan 18, 2002► Subscribe► Subscribe
Swedish Orphan
ORFADIN
nitisinone
CAPSULE;ORAL021232-003Jan 18, 2002► Subscribe► Subscribe
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International Patent Family for Ingredient: nitisinone

Country Document Number Estimated Expiration
European Patent Office2723320► Subscribe
CroatiaP20160286► Subscribe
Australia2012273515► Subscribe
Cyprus1117273► Subscribe
New Zealand618332► Subscribe
Japan6038132► Subscribe
Slovenia2723320► Subscribe
Mexico2013014567► Subscribe
Ukraine110979► Subscribe
Denmark2723320► 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: NITISINONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0024France► SubscribePRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 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
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Julphar
McKinsey
Boehringer Ingelheim
Citi
US Department of Justice
UBS
Federal Trade Commission
Chubb
Mallinckrodt
Moodys

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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