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Last Updated: December 9, 2019

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NITYR Drug Profile

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When do Nityr patents expire, and what generic alternatives are available?

Nityr is a drug marketed by Cycle Pharms Ltd and is included in one NDA. There is one patent protecting this drug.

This drug has four patent family members in four countries.

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

Summary for NITYR
International Patents:4
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 1
DailyMed Link:NITYR at DailyMed
Drug patent expirations by year for NITYR

US Patents and Regulatory Information for NITYR

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 209449-001 Jul 26, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Cycle Pharms Ltd NITYR nitisinone TABLET;ORAL 209449-002 Jul 26, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Cycle Pharms Ltd NITYR nitisinone TABLET;ORAL 209449-003 Jul 26, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for NITYR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0591275 05C0024 France   Start Trial PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
0591275 C300198 Netherlands   Start Trial PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201
0591275 SPC/GB05/030 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
Baxter
Moodys
Mallinckrodt
Johnson and Johnson

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