RELYVRIO Drug Patent Profile
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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 |
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
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amylyx | RELYVRIO | sodium phenylbutyrate; taurursodiol | FOR SUSPENSION;ORAL | 216660-001 | Sep 29, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Amylyx | RELYVRIO | sodium phenylbutyrate; taurursodiol | FOR SUSPENSION;ORAL | 216660-001 | Sep 29, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Amylyx | RELYVRIO | sodium phenylbutyrate; taurursodiol | FOR SUSPENSION;ORAL | 216660-001 | Sep 29, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2019200658 | Compositions for improving cell viability and methods of use thereof | ⤷ Try a Trial |
Slovenia | 2978419 | ⤷ Try a Trial | |
Argentina | 120774 | COMPOSICIONES DE ÁCIDOS BILIARES Y COMPUESTOS DE FENILBUTIRATO | ⤷ Try a Trial |
Australia | 2021201770 | 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 |
---|---|---|---|---|
2666774 | CA 2020 00037 | Denmark | ⤷ Try a Trial | PRODUCT NAME: RELEBACTAM, OPTIONALLY IN THE FORM OF THE MONOHYDRATE, IMIPENEM AND CILASTATIN, OPTIONALLY IN THE FORM OF THE SODIUM SALT; REG. NO/DATE: EU/1/19/1420 20200217 |
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 |
2666774 | LUC00167 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: RELEBACTAM, EVENTUELLEMENT SOUS FORME DE MONOHYDRATE, IMIPENEME ET CILASTATINE, EVENTUELLEMENT SOUS FORME DE SEL DE SODIUM; AUTHORISATION NUMBER AND DATE: EU/1/19/1420 20200217 |
0145340 | 99C0005 | Belgium | ⤷ Try a Trial | PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |