You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: May 28, 2024

NITYR Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

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

This drug has fourteen patent family members in fourteen countries.

The generic ingredient in NITYR is nitisinone. There are two drug master file entries for this compound. Six 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.

  Sign Up

US Patents and Regulatory Information for NITYR

NITYR is protected by one US patents.

Patents protecting NITYR

Pharmaceutical composition
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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 NITYR nitisinone TABLET;ORAL 209449-001 Jul 26, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Cycle NITYR nitisinone TABLET;ORAL 209449-002 Jul 26, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Cycle NITYR nitisinone TABLET;ORAL 209449-003 Jul 26, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for NITYR

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
MendeliKABS Europe Ltd Nitisinone MDK (previously Nitisinone MendeliKABS) nitisinone EMEA/H/C/004281
Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.
Withdrawn yes no no 2017-08-24
Cycle Pharmaceuticals (Europe) Ltd Nityr nitisinone EMEA/H/C/004582
Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.
Authorised yes no no 2018-07-26
Swedish Orphan Biovitrum International AB Orfadin nitisinone EMEA/H/C/000555
Hereditary tyrosinemia type 1 (HT 1)Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.Alkaptonuria (AKU)Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).
Authorised no no no 2005-02-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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 ⤷  Sign Up
Hungary E050881 ⤷  Sign Up
Cyprus 1123394 ⤷  Sign Up
Canada 2935013 COMPOSITION PHARMACEUTIQUE CONTENANT DE LA NITISINONE ET UTILISATION (PHARMACEUTICAL COMPOSITION CONTAINING NITISINONE, AND ITS USE) ⤷  Sign Up
United Kingdom 201400117 ⤷  Sign Up
European Patent Office 3089740 COMPOSITION PHARMACEUTIQUE (PHARMACEUTICAL COMPOSITION) ⤷  Sign Up
>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 ⤷  Sign Up 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 ⤷  Sign Up 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
0591275 05C0024 France ⤷  Sign Up PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.