RELYVRIO Drug Patent Profile
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When do Relyvrio patents expire, and when can generic versions of Relyvrio launch?
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RELYVRIO
Generic Entry Date for RELYVRIO*:
Constraining patent/regulatory exclusivity:
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS NDA:
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 |
Pharmacology for RELYVRIO
Drug Class | Nitrogen Binding Agent |
Mechanism of Action | Ammonium Ion Binding Activity |
Anatomical Therapeutic Chemical (ATC) Classes for RELYVRIO
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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS
Compositions for improving cell viability and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS
Compositions for improving cell viability and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Compositions for improving cell viability and methods of use thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS
FDA Regulatory Exclusivity protecting RELYVRIO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS
Exclusivity Expiration: ⤷ Try a Trial
International Patents for RELYVRIO
See the table below for patents covering RELYVRIO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 102223250 | ⤷ Try a Trial | |
China | 114929211 | 胆汁酸和苯丁酸化合物的组合物 (Compositions of bile acid and phenylbutyric acid compounds) | ⤷ Try a Trial |
Australia | 2019200658 | Compositions for improving cell viability and methods of use thereof | ⤷ Try a Trial |
South Korea | 20210025134 | 세포 생존력을 향상시키기 위한 조성물 및 이의 사용 방법 (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF) | ⤷ Try a Trial |
Spain | 2796250 | ⤷ Try a Trial | |
Japan | 2023507152 | 胆汁酸及びフェニル酪酸化合物の組成物 | ⤷ Try a Trial |
Montenegro | 03747 | KOMPOZICIJE ZA POBOLJŠANJE ĆELIJSKE VIJABILNOSTI I POSTUPCI ZA NJIHOVU UPOTREBU (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RELYVRIO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1666481 | 17C1031 | France | ⤷ Try a Trial | PRODUCT NAME: TOFACITINIB,EVENTUELLEMENT SOUS LA FORME D'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,DONT LE CITRATE DE SODIUM; REGISTRATION NO/DATE: EU/1/17/1178 20170324 |
2822954 | SPC/GB18/031 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM.; REGISTERED: UK EU/1/18/1289/001(NI) 20180625; UK EU/1/18/1289/002(NI) 20180625; UK PLGB 11972/0008 20180625 |
1713823 | 1490064-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516 |
2673237 | LUC00111 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; AUTHORISATION NUMBER AND DATE: EU/1/17/1173 20180326 |
2203431 | 92666 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119 |
1874117 | SPC/GB14/041 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121 |
2203431 | CR 2015 00014 | Denmark | ⤷ Try a Trial | PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |