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Serving leading biopharmaceutical companies globally:

US Department of Justice
Chinese Patent Office
Farmers Insurance
Express Scripts
Argus Health
Teva
Cerilliant
Fish and Richardson
UBS
AstraZeneca

Generated: January 19, 2018

DrugPatentWatch Database Preview

ORFADIN Drug Profile

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Which patents cover Orfadin, and when can generic versions of Orfadin launch?

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

This drug has twenty-two patent family members in twenty countries.

The generic ingredient in ORFADIN is nitisinone. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitisinone profile page.

US Patents and Regulatory Information for ORFADIN

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 CAPSULE;ORAL 021232-001 Jan 18, 2002 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-004 Jun 13, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Swedish Orphan ORFADIN nitisinone SUSPENSION;ORAL 206356-001 Apr 22, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ 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 ORFADIN

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 ORFADIN

Supplementary Protection Certificates for ORFADIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Covington
US Army
Fuji
Colorcon
Cerilliant
Johnson and Johnson
Medtronic
Julphar
Cantor Fitzgerald

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