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The generic ingredient in ORFADIN is nitisinone. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the nitisinone profile page.
Generic Entry Opportunity Date for 206356
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Profile for product number 001
|Approval Date:||Apr 22, 2016||TE:||RLD:||Yes|
|Regulatory Exclusivity Expiration:||Sep 1, 2020|
|Regulatory Exclusivity Use:||ONCE-DAILY DOSING FOR PATIENTS 5 YEARS OF AGE AND OLDER WHO HAVE UNDETECTABLE SERUM AND URINE SUCCINYLACETONE CONCENTRATIONS AFTER A MINIMUM OF 4 WEEKS ON A STABLE DOSAGE OF NITISINONE|
|Patent:||➤ Try a Free Trial||Patent Expiration:||Feb 28, 2033||Product Flag?||Y||Substance Flag?||Delist Request?|
|Patented Use:||TREATMENT OF HEREDITARY TYROSINEMIA TYPE 1 (HT-1) IN COMBINATION WITH DIETARY RESTRICTION OF TYROSINE AND PHENYLALANIE|
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