Relyvrio is a drug owned by Amylyx Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2022 to 2023 out of which none have expired yet. Relyvrio's patents will be open to challenges from 29 September, 2026. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 27, 2040. Details of Relyvrio's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11583542 | Compositions of bile acids and phenylbutyrate compounds |
Jul, 2040
(15 years from now) | Active |
| US9872865 | Compositions for improving cell viability and methods of use thereof |
Dec, 2033
(9 years from now) | Active |
| US11071742 | Compositions for improving cell viability and methods of use thereof |
Dec, 2033
(9 years from now) | Active |
| US10857162 | Compositions for improving cell viability and methods of use thereof |
Dec, 2033
(9 years from now) | Active |
| US10251896 | Compositions for improving cell viability and methods of use thereof |
Dec, 2033
(9 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Relyvrio's patents.
Latest Legal Activities on Relyvrio's Patents
Given below is the list of recent legal activities going on the following patents of Relyvrio.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US10857162 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US11071742 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US10251896 |
| transaction for FDA Determination of Regulatory Review Period | 14 Mar, 2024 | US9872865 |
| transaction for FDA Determination of Regulatory Review Period | 04 Mar, 2024 | US10857162 |
| transaction for FDA Determination of Regulatory Review Period | 04 Mar, 2024 | US11071742 |
| transaction for FDA Determination of Regulatory Review Period | 04 Mar, 2024 | US10251896 |
| transaction for FDA Determination of Regulatory Review Period | 04 Mar, 2024 | US9872865 |
| Second letter to regulating agency to determine regulatory review period | 30 Sep, 2023 | US10251896 |
| Second letter to regulating agency to determine regulatory review period | 30 Sep, 2023 | US10857162 |
FDA has granted several exclusivities to Relyvrio. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Relyvrio, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Relyvrio.
Exclusivity Information
Relyvrio holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2029. Details of Relyvrio's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 29, 2027 |
| Orphan Drug Exclusivity(ODE-411) | Sep 29, 2029 |
Several oppositions have been filed on Relyvrio's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Relyvrio's generic, the next section provides detailed information on ongoing and past EP oppositions related to Relyvrio patents.
Relyvrio's Oppositions Filed in EPO
Relyvrio has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 11, 2021, by Bruschettini S.R.L.. This opposition was filed on patent number EP14775675A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP14775675A | Jan, 2021 | Lederer & Keller Patentanwälte Partnerschaft mbB | Opposition rejected |
| EP14775675A | Jan, 2021 | Bruschettini S.r.l. | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Relyvrio is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Relyvrio's family patents as well as insights into ongoing legal events on those patents.
Relyvrio's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Relyvrio's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 27, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Relyvrio Generics:
There are no approved generic versions for Relyvrio as of now.
About Relyvrio
Relyvrio is a drug owned by Amylyx Pharmaceuticals Inc. It is used for the treatment of Amyotrophic Lateral Sclerosis (ALS) in adults. Relyvrio uses Sodium Phenylbutyrate; Taurursodiol as an active ingredient. Relyvrio was launched by Amylyx in 2022.
Approval Date:
Relyvrio was approved by FDA for market use on 29 September, 2022.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Relyvrio is 29 September, 2022, its NCE-1 date is estimated to be 29 September, 2026.
Active Ingredient:
Relyvrio uses Sodium Phenylbutyrate; Taurursodiol as the active ingredient. Check out other Drugs and Companies using Sodium Phenylbutyrate; Taurursodiol ingredient
Treatment:
Relyvrio is used for the treatment of Amyotrophic Lateral Sclerosis (ALS) in adults.
Dosage:
Relyvrio is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3GM/PACKET; 1GM/PACKET | FOR SUSPENSION | Discontinued | ORAL |