Last Updated: November 8, 2026

Details for Patent: 10,328,029

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Which drugs does patent 10,328,029 protect, and when does it expire?

Patent 10,328,029 protects NITYR and is included in one NDA.

This patent has fifteen patent family members in fifteen countries.

Summary for Patent: 10,328,029
Title:Pharmaceutical composition
Abstract:The present invention relates to oral pharmaceutical compositions comprising nitisinone, or a pharmaceutically acceptable salt thereof, their use in the treatment of tyrosinemia, such as Hereditary Tyrosinemia type-1 (HT-1), or alkaptonuria. The compositions have improved stability characteristics. The invention also relates to processes for producing nitisinone.
Inventor(s):James Harrison, Stephen Fuller, Tobias Josef Brown
Assignee: Cycle Pharmaceuticals Ltd
Application Number:US15/109,220
Patent Claim Types:
see list of patent claims
Use; Composition; Dosage form;

Drugs Protected by US Patent 10,328,029

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cycle NITYR nitisinone TABLET;ORAL 209449-001 Jul 26, 2017 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANINE ⤷  Start Trial
Cycle NITYR nitisinone TABLET;ORAL 209449-002 Jul 26, 2017 RX Yes No ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANINE ⤷  Start Trial
Cycle NITYR nitisinone TABLET;ORAL 209449-003 Jul 26, 2017 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANINE ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,328,029

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom1400117.6Jan 3, 2014
PCT Information
PCT FiledJanuary 05, 2015PCT Application Number:PCT/GB2015/050006
PCT Publication Date:July 09, 2015PCT Publication Number: WO2015/101794

International Family Members for US Patent 10,328,029

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Canada 2935013 ⤷  Start Trial
Cyprus 1123394 ⤷  Start Trial
Denmark 3089740 ⤷  Start Trial
European Patent Office 3089740 ⤷  Start Trial
Spain 2806739 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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