Relyvrio Patent Expiration

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.

Given below is the list of recent legal activities going on the following patents of Relyvrio.

Activity Date Patent Number
Patent litigations
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

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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
Patent litigations
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

Relyvrio has patent protection in a total of 22 countries. It's US patent count contributes only to 25.9% of its total global patent coverage. Click below to unlock the full patent family tree for Relyvrio.

Family Patents

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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


Relyvrio News

Amylyx removes ALS medication from US market following study indicating no positive effects - KFF Health News

05 Apr, 2024

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