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RELYVRIO Drug Patent Profile

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Which patents cover Relyvrio, and what generic alternatives are available?

Relyvrio is a drug marketed by Amylyx and is included in one NDA. There are five patents protecting this drug.

This drug has fifty-four patent family members in twenty-four countries.

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.

DrugPatentWatch^® Generic Entry Outlook for Relyvrio

Relyvrio will be eligible for patent challenges on September 29, 2026. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 29, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for RELYVRIO

International Patents:	54
US Patents:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	1
Drug Prices:	Drug price information for RELYVRIO
What excipients (inactive ingredients) are in RELYVRIO?	RELYVRIO excipients list
DailyMed Link:	RELYVRIO at DailyMed

Drug patent expirations by year for RELYVRIO

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

Generic Entry Date for RELYVRIO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS NDA: 216660 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.

Recent Clinical Trials for RELYVRIO

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Amylyx Pharmaceuticals Inc.	Phase 3

See all RELYVRIO clinical trials

Pharmacology for RELYVRIO

Drug Class	Nitrogen Binding Agent
Mechanism of Action	Ammonium Ion Binding Activity

US Patents and Regulatory Information for RELYVRIO

RELYVRIO is protected by five US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of RELYVRIO is ⤷ Sign Up.

This potential generic entry date is based on TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting RELYVRIO

Compositions for improving cell viability and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS

Compositions for improving cell viability and methods of use thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

FDA Regulatory Exclusivity protecting RELYVRIO

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for RELYVRIO

See the table below for patents covering RELYVRIO around the world.

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Country	Patent Number	Title	Estimated Expiration
Brazil	112022011948		⤷ Sign Up
Montenegro	03747	KOMPOZICIJE ZA POBOLJŠANJE ĆELIJSKE VIJABILNOSTI I POSTUPCI ZA NJIHOVU UPOTREBU (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF)	⤷ Sign Up
Denmark	2978419		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for RELYVRIO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1856135	CA 2020 00018	Denmark	⤷ Sign Up	PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REG. NO/DATE: EU/1/19/1405 20200113
3347352	2290051-8	Sweden	⤷ Sign Up	PRODUCT NAME: LENACAPAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR LENACAPAVIR SODIUM; REG. NO/DATE: EU/1/22/1671 20220819
2380576	2020/043	Ireland	⤷ Sign Up	PRODUCT NAME: DEOXYCHOLIC ACID SODIUM SALT; NAT REGISTRATION NO/DATE: PA2103/003/001 20170602; FIRST REGISTRATION NO/DATE: SE/H/1547/001/DC 20160729
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description