RELYVRIO Drug Patent Profile
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Which patents cover Relyvrio, 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 ⤷ 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
International Patents for RELYVRIO
See the table below for patents covering RELYVRIO around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 105050593 | Compositions for improving cell viability and methods of use thereof | ⤷ Sign Up |
South Korea | 102223250 | ⤷ Sign Up | |
China | 109999043 | 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) | ⤷ Sign Up |
Australia | 2022221410 | Compositions for improving cell viability and methods of use thereof | ⤷ Sign Up |
Japan | 2021008473 | 細胞生存率を向上させるための組成物およびその使用方法 (COMPOSITION FOR IMPROVING CELL VIABILITY AND METHOD OF USE THEREOF) | ⤷ Sign Up |
South Korea | 102607635 | ⤷ Sign Up | |
China | 114929211 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for RELYVRIO
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 |
0268956 | 1999C0030 | Belgium | ⤷ Sign Up | PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508 |
2822954 | SPC/GB18/031 | United Kingdom | ⤷ Sign Up | 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 |
3141251 | SPC/GB20/075 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: A MEDICINAL PRODUCT CONSISTING OF A COMBINATION OF A FIRST DOSE PHARMACEUTICAL COMPOSITION AND A SECOND DOSE PHARMACEUTICAL COMPOSITION, THE FIRST DOSE PHARMACEUTICAL COMPOSITION CONSISTING OF THE ACTIVE INGREDIENTS: POLYETHYLENE GLYCOL 3350, SODIUM SULPH; REGISTERED: IS IS/1/17/063/01 20171016; UK PL 20011/0040 20171016 |
1856135 | 2020/017 | Ireland | ⤷ 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; REGISTRATION NO/DATE: EU/1/19/1405 20200113 |
0806968 | SPC/GB07/011 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: GADOFOSVESET TRISODIUM; REGISTERED: UK EU/1/05/313/001 20051003; UK EU/1/05/313/002 20051003; UK EU/1/05/313/003 20051003; UK EU/1/05/313/004 20051003; UK EU/1/05/313/005 20051003; UK EU/1/05/313/006 20051003; UK EU/1/05/313/007 20051003; UK EU/1/05/313/008 20051003; UK EU/1/05/313/009 20051003 |
1666481 | 17C1031 | France | ⤷ Sign Up | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |