Details for New Drug Application (NDA): 216660

NDA 216660 describes RELYVRIO, which is a drug marketed by Amylyx and is included in one NDA. There are five patents protecting this drug. Additional details are available on the RELYVRIO profile page.

The generic ingredient in RELYVRIO is sodium phenylbutyrate; taurursodiol. There are one thousand four hundred and seventy-two drug master file entries for this compound. Additional details are available on the sodium phenylbutyrate; taurursodiol profile page.

Summary for 216660

Tradename:	RELYVRIO
Applicant:	Amylyx
Ingredient:	sodium phenylbutyrate; taurursodiol
Patents:	5

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 216660

Constraining patent/regulatory exclusivity:

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS

Dosage:

FOR SUSPENSION;ORAL

^*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

Active Rx/OTC/Discontinued:	DISCN	Dosage:	FOR SUSPENSION;ORAL			Strength	3GM/PACKET; 1GM/PACKET
Approval Date:	Sep 29, 2022	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 29, 2027
Regulatory Exclusivity Use:	NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:	Sep 29, 2029
Regulatory Exclusivity Use:	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS
Patent:		Patent Expiration:	Dec 24, 2033	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS

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