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Last Updated: November 7, 2024

NITISINONE - Generic Drug Details


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What are the generic drug sources for nitisinone and what is the scope of patent protection?

Nitisinone is the generic ingredient in three branded drugs marketed by Eton, Medunik, Novitium Pharma, Torrent, Swedish Orphan, and Cycle, and is included in seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nitisinone has thirty-eight patent family members in twenty-five countries.

There are two drug master file entries for nitisinone. Six suppliers are listed for this compound.

Summary for NITISINONE
International Patents:38
US Patents:2
Tradenames:3
Applicants:6
NDAs:7
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 6
Raw Ingredient (Bulk) Api Vendors: 125
Clinical Trials: 16
Patent Applications: 784
Drug Prices: Drug price trends for NITISINONE
What excipients (inactive ingredients) are in NITISINONE?NITISINONE excipients list
DailyMed Link:NITISINONE at DailyMed
Drug Prices for NITISINONE

See drug prices for NITISINONE

Recent Clinical Trials for NITISINONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sutphin DrugsN/A
Cycle Pharmaceuticals Ltd.Phase 1
ParexelPhase 1

See all NITISINONE clinical trials

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
Swedish Orphan ORFADIN nitisinone SUSPENSION;ORAL 206356-001 Apr 22, 2016 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Medunik NITISINONE nitisinone CAPSULE;ORAL 212390-003 May 26, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cycle NITYR nitisinone TABLET;ORAL 209449-002 Jul 26, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Eton NITISINONE nitisinone CAPSULE;ORAL 216201-003 May 25, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novitium Pharma NITISINONE nitisinone CAPSULE;ORAL 211041-001 Aug 26, 2019 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for NITISINONE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 Jan 18, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for NITISINONE

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 NITISINONE

Country Patent Number Title Estimated Expiration
Cyprus 1117273 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2012177214 ⤷  Sign Up
Spain 2806739 ⤷  Sign Up
Australia 2012273515 Liquid pharmaceutical composition comprising nitisinone ⤷  Sign Up
Canada 2838039 COMPOSITION PHARMACEUTIQUE LIQUIDE COMPRENANT DE LA NITISINONE (LIQUID PHARMACEUTICAL COMPOSITION COMPRISING NITISINONE) ⤷  Sign Up
Cyprus 1123394 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for NITISINONE

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 05C0024 France ⤷  Sign Up PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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