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.
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 Action | Ammonium 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) |
| RELYVRIO | sodium phenylbutyrate; taurursodiol | FOR SUSPENSION;ORAL | 216660 | NDA | Amylyx Pharmaceuticals Inc | 73063-035 | 73063-035-04 | 7 POWDER, FOR SUSPENSION in 1 CARTON (73063-035-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | 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: | ⤷ Sign Up | 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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