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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Covington
McKesson
Federal Trade Commission
Julphar
Moodys
Dow
AstraZeneca
Boehringer Ingelheim
US Army

Generated: January 20, 2018

DrugPatentWatch Database Preview

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-two patent family members in twenty countries.

There are two drug master file entries for nitisinone. Two suppliers are listed for this compound.
Summary for nitisinone
International Patents:22
US Patents:1
Tradenames:2
Applicants:2
NDAs:3
Drug Master File Entries: 2
Suppliers / Packagers: 2
Bulk Api Vendors: 81
Clinical Trials: 15
Patent Applications: 273
Drug Prices:see low prices
DailyMed Link:nitisinone at DailyMed

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Cycle Pharms Ltd NITYR nitisinone TABLET;ORAL 209449-002 Jul 26, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Cycle Pharms Ltd NITYR nitisinone TABLET;ORAL 209449-001 Jul 26, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Swedish Orphan ORFADIN nitisinone SUSPENSION;ORAL 206356-001 Apr 22, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-004 Jun 13, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 Jan 18, 2002 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for nitisinone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 ➤ Subscribe ➤ Subscribe
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 Jan 18, 2002 ➤ Subscribe ➤ Subscribe
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 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
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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International Patents for nitisinone

Supplementary Protection Certificates for nitisinone

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C0024 France ➤ Subscribe PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Covington
Daiichi Sankyo
QuintilesIMS
Fuji
Harvard Business School
Merck
Cipla
Teva
Novartis

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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