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RELYVRIO Drug Patent Profile

When do Relyvrio patents expire, 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

Summary for RELYVRIO

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

See drug prices for RELYVRIO

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

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

Anatomical Therapeutic Chemical (ATC) Classes for RELYVRIO

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for RELYVRIO

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

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

FDA Regulatory Exclusivity protecting RELYVRIO

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
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes			Y
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		RX	Yes	Yes

International Patents for RELYVRIO

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

Country	Patent Number	Title	Estimated Expiration
Montenegro	03747	KOMPOZICIJE ZA POBOLJŠANJE ĆELIJSKE VIJABILNOSTI I POSTUPCI ZA NJIHOVU UPOTREBU (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF)
Hong Kong	1216851	用於提高細胞存活力的組合物和使用該組合物的方法 (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF)
China	110787169	用于提高细胞存活力的组合物和使用该组合物的方法 (Compositions for improving cell viability and methods of use thereof)
Taiwan	202135791	Compositions of bile acids and phenylbutyrate compounds
South Korea	20150135471	세포 생존력을 향상시키기 위한 조성물 및 이의 사용 방법 (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF)
Australia	2021201770	Compositions for improving cell viability and methods of use thereof

Supplementary Protection Certificates for RELYVRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
2203431	1590018-6	Sweden		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
0480717	SPC/GB98/025	United Kingdom		PRODUCT NAME: MONTELUKAST, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, PREFERABLY MONTELUKAST SODIUM; REGISTERED: FI 12766 19970825; FI 12767 19970825; UK 00025/0357 19980115; UK 00025/0358 19980115
2203431	15C0013	France		PRODUCT NAME: DASABUVIR OU UN SEL DE CELUI-CI, NOTAMMENT LE SEL DE SODIUM; REGISTRATION NO/DATE: EU/1/14/983 20150119
1856135	CR 2020 00018	Denmark		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
2822954	LUC00083	Luxembourg		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/18/1289 20180625