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Last Updated: May 19, 2022

NITYR Drug Patent 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 thirteen patent family members in thirteen countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Nityr

A generic version of NITYR was approved as nitisinone by NOVITIUM PHARMA on August 26th, 2019.

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US Patents and Regulatory Information for NITYR

NITYR is protected by one US patents.

Patents protecting NITYR

Pharmaceutical composition
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANINE

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

International Patents for NITYR

See the table below for patents covering NITYR around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2015101794 See Plans and Pricing
European Patent Office 3089740 COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) See Plans and Pricing
Spain 2806739 See Plans and Pricing
Denmark 3089740 See Plans and Pricing
Lithuania 3089740 See Plans and Pricing
Serbia 60551 FARMACEUTSKA KOMPOZICIJA (PHARMACEUTICAL COMPOSITION) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NITYR

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

AstraZeneca
Harvard Business School
Moodys
McKinsey
Merck
Johnson and Johnson

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