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
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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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for RELYVRIO
*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 |
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
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
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
FDA Regulatory Exclusivity protecting RELYVRIO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS
Exclusivity Expiration: ⤷ Sign Up
| 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 | |||
| 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 | ⤷ 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.
| 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 | |
| Argentina | 120774 | ⤷ Sign Up | |
| Serbia | 60596 | KOMPOZICIJE ZA POBOLJŠANJE ĆELIJSKE VIJABILNOSTI I POSTUPCI ZA NJIHOVU UPOTREBU (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF) | ⤷ Sign Up |
| South Korea | 20210025134 | 세포 생존력을 향상시키기 위한 조성물 및 이의 사용 방법 (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF) | ⤷ Sign Up |
| Australia | 2014242123 | Compositions for improving cell viability and methods of use thereof | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RELYVRIO
| 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 |
| 2380576 | 20C1048 | France | ⤷ Sign Up | PRODUCT NAME: SEL DE SODIUM DE L'ACIDE DESOXYCHOLIQUE; NAT. REGISTRATION NO/DATE: NL46299 20180810; FIRST REGISTRATION: IS - IS/1/16/071/01 20160729 |
| 1912999 | 14C0076 | France | ⤷ Sign Up | PRODUCT NAME: SIMEPREVIR OU L'UN DE SES SELS, INCLUANT LE SEL DE SODIUM DE SIMEPREVIR; REGISTRATION NO/DATE: EU/1/14/924 20140516 |
| 0480717 | 98C0022 | France | ⤷ Sign Up | PRODUCT NAME: MONTELUKAST SODIUM; REGISTRATION NO/DATE IN FRANCE: NL 23 133 DU 19980320; REGISTRATION NO/DATE AT EEC: 13 651 DU 19970825 |
| 2666774 | LUC00167 | Luxembourg | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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