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Last Updated: December 23, 2024

Details for New Drug Application (NDA): 216660


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NDA 216660 describes RELYVRIO, which is a drug marketed by Amylyx and is included in one NDA. It is available from one supplier. 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. One supplier is listed 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
Generic Entry 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.

Pharmacology for NDA: 216660
Mechanism of ActionAmmonium Ion Binding Activity
Suppliers and Packaging for NDA: 216660
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RELYVRIO sodium phenylbutyrate; taurursodiol FOR SUSPENSION;ORAL 216660 NDA Amylyx Pharmaceuticals Inc 73063-035 73063-035-03 56 POWDER, FOR SUSPENSION in 1 CARTON (73063-035-03)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FOR SUSPENSION;ORALStrength3GM/PACKET; 1GM/PACKET
Approval Date:Sep 29, 2022TE: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:⤷  SubscribePatent Expiration:Dec 24, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS

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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.