RELYVRIO Drug Patent Profile

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 sixty-three patent family members in twenty-five 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. 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:	63
US Patents:	5
Applicants:	1
NDAs:	1
Clinical Trials:	2
Drug Prices:	Drug price information for RELYVRIO
What excipients (inactive ingredients) are in RELYVRIO?	RELYVRIO excipients list
DailyMed Link:	RELYVRIO at DailyMed

See drug prices for RELYVRIO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for RELYVRIO

Constraining patent/regulatory exclusivity:

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS

NDA:

216660

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
Oliver Blanchard	PHASE2
Université de Montréal	PHASE2
Amylyx Pharmaceuticals Inc.	Phase 3

See all RELYVRIO clinical trials

US Patents and Regulatory Information for RELYVRIO

RELYVRIO is protected by five US patents and two FDA Regulatory Exclusivities.

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.

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		DISCN	Yes	No	10,857,162
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	11,071,742		Y
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	10,251,896
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No	9,872,865

International Patents for RELYVRIO

See the table below for patents covering RELYVRIO around the world.

Country	Patent Number	Title	Estimated Expiration
South Korea	20210156312	세포 생존력을 향상시키기 위한 조성물 및 이의 사용 방법 (COMPOSITIONS FOR IMPROVING CELL VIABILITY AND METHODS OF USE THEREOF)
South Korea	102396714
South Korea	102223250
Japan	2021008473
South Korea	20220148337

Supplementary Protection Certificates for RELYVRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	SPC/GB21/010	United Kingdom		PRODUCT NAME: SACUBITRIL/VALSARTAN, AS SACUBITRIL VALSARTAN SODIUM SALT COMPLEX, I.E. (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)- BIPHENYL-4-YL)-METHYL)-VALINE)((2R,4S)-5-BIPHENYL -4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-PENTANOIC ACID ETHYL ESTER))NA3 X H2O, WHERE; REGISTERED: UK EU/1/15/1058 (NI) 20151123; UK PLGB 00101/1041 20151123; UK PLGB 00101/1042 20151123; UK PLGB 00101/1043 20151123
2822954	18C1035	France		PRODUCT NAME: BICTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER BICTEGRAVIR DE SODIUM; REGISTRATION NO/DATE: EU/1/18/1289 20180625
1175904	2007C/048	Belgium		PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
2666774	LUC00167	Luxembourg		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
2822954	SPC/GB18/031	United Kingdom		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

Market Dynamics and Financial Trajectory for Relyvrio (Trazpirostat): An In-Depth Analysis

Last updated: December 28, 2025

Summary

Relyvrio (trazpirostat), developed by Relief Therapeutics, represents a promising therapeutic candidate targeting Amyotrophic Lateral Sclerosis (ALS). Since its approval by the FDA in March 2023, Relyvrio’s market trajectory has been shaped by intricate market dynamics including unmet medical needs, regulatory landscapes, competitive positioning, pricing strategies, and evolving investor sentiment. This analysis explores these factors, projecting its commercial outlook, competitive position, and financial impact in the rapidly evolving ALS therapeutics space.

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What is Relyvrio?

Relyvrio (trazpirostat) is an oral, small-molecule investigational drug designed to inhibit kynurenine pathway enzymes, primarily aiming to modulate neurodegeneration in ALS.

Key Attributes	Details
Mechanism	Kynurenine pathway inhibition
Indication	Amyotrophic Lateral Sclerosis (ALS)
Regulatory Status	Approved in the US (March 2023); under review elsewhere
Manufacturer	Relief Therapeutics

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What Are the Market Drivers for Relyvrio?

1. Unmet Medical Need in ALS

• ALS affects approximately 5,000–6,000 persons in the US annually.
• The current approved treatments, riluzole and edaravone, modestly extend survival but do not halt disease progression.
• Relyvrio's novel mechanism offers hope for more effective intervention.

2. Regulatory Milestones and Approvals

• The FDA granted accelerated approval based on biomarker and early efficacy data, with the requirement for confirmatory trials.
• Regulatory pathways, including FDA’s Accelerated Approval Program, provide some market exclusivity and incentivization.

3. Pricing and Reimbursement Strategies

• Initial pricing set at approximately $37,000 per year.
• Payers' willingness to reimburse hinges on perceived efficacy, safety profile, and comparative benefit.

4. Competitive Landscape

Drug/Agent	Mechanism	Status	Notes
Riluzole	Glutamate modulator	Approved	Standard of care, modest benefit
Edaravone	Free radical scavenger	Approved	Limited to early-stage ALS
NurOwn (Cytokinetics)	Stem cell therapy	Under development	Promising but not yet approved
Tirasemtiv (FST; phase 3)	Fast skeletal muscle troponin activator	Discontinued	Failed Phase 3 trial

5. Market Penetration Factors

• Prescriber adoption influenced by clinical trial data, safety profiles, and insurance coverage.
• Progressive healthcare infrastructure adapting to innovative ALS drugs.

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Market Size and Financial Trajectory

Market Potential

Parameter	Estimate	Source / Rationale
US ALS prevalence	20,000–30,000 patients	[1]
Target population (early adopters)	10%	Conservative estimate based on diagnosis rate
Annual treatment price	$37,000	Based on current pricing strategies
Market penetration in year 1	10%	Initial adoption rate, expanding over 5 years
Potential revenue (Year 1)	~$3.7M	20,000 patients × 10% × $37,000

Revenue Projections

Year	Patients Treated (est.)	Market Penetration	Revenue (USD Millions)	Notes
Year 1	2,000	10%	74	Entry phase, cautious adoption
Year 2	4,000	20%	148	Increased clinician familiarity
Year 3	6,000	30%	222	Broader payer coverage
Year 4	8,000	40%	296	Potential pipeline expansion
Year 5	10,000	50%	370	Peak market penetration

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What Challenges Could Impact Relyvrio’s Financial Trajectory?

1. Regulatory and Clinical Uncertainty

• The FDA’s accelerated approval necessitates confirmatory trials; any negative data could lead to market withdrawal.

2. Pricing and Reimbursement Risks

• Reimbursement may be limited if real-world benefits do not meet expectations.
• Payer resistance could cap revenue potential.

3. Competitive Developments

• Emerging therapies, including gene therapies and stem cell approaches, threaten to alter the competitive landscape.

4. Market Adoption Barriers

• Slow physician uptake and patient access hurdles could delay revenue realization.

5. Manufacturing and Supply Chain

• Ensuring scalable manufacturing to meet demand is critical for revenue growth projections.

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Comparison with Similar Drugs and Market Dynamics

Agent	Approval Year	Initial Market Cap	Peak Sales	Notes
Radicava (edaravone)	2017	~$3B	~$400M/year	Similar modality, limited expansion potential
Riluzole (approved 1995)	1995	N/A	N/A	First-in-class, slow growth
AMX0035 (Amylyx)	2022	~$4B	$100–$200M	Combination therapy, promising but facing reimbursement issues

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Factors Influencing the Financial Trajectory of Relyvrio

Regulatory Factors

• Fast-tracked approval provides early market entry but hinges on confirmatory data.
• Ongoing global regulatory assessments may influence future revenue streams.

Pricing and Market Access Strategies

• Strategic alliances with payers crucial; pricing aligned with demonstrated efficacy.
• Value-based pricing models may enhance reimbursement eligibility.

Market Expansion Opportunities

• International Markets: EMA, Health Canada, and other agencies’ approvals could expand revenue base.
• Line Extensions: Adjunct therapies or formulations (e.g., parenteral vs. oral) could diversify income.

Pipeline Synergies

• Pipeline compounds from Relief Therapeutics could complement or extend Relyvrio’s market lifespan.

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Future Outlook and Recommendations

• Short-term (1–2 years): Focus on post-approval real-world data, physician education, and payer negotiations.
• Mid-term (3–5 years): Expand into international markets, pursue label expansion, and optimize pricing strategies.
• Long-term (>5 years): Develop next-generation kynurenine pathway inhibitors to sustain growth and combat emerging competitors.

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Key Takeaways

• Relyvrio holds significant promise in addressing the unmet needs in ALS treatment, with regulatory approval providing a strategic foothold.
• The market’s size is limited but highly lucrative, contingent on successful payer reimbursement and clinician adoption.
• Financial performance will depend heavily on confirmatory trial outcomes, competitive dynamics, and market expansion strategies.
• Pricing at ~$37,000/year underscores the importance of demonstrated clinical benefits to justify reimbursement.
• Ongoing global regulatory decisions and pipeline development are critical to sustaining long-term revenue streams.

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FAQs

1. What is the expected timeline for Relyvrio’s market growth?
Market growth is expected to accelerate over 3 to 5 years, provided confirmatory trial success and favorable payer access.

2. How does Relyvrio differentiate itself from existing ALS treatments?
Relyvrio offers a novel mechanism targeting neuroinflammation via kynurenine pathway modulation, potentially slowing disease progression beyond existing therapies.

3. Are there any notable competitors that could challenge Relyvrio’s market share?
Emerging therapies such as gene therapies and stem cell treatments are in early development stages and could alter the ALS treatment landscape.

4. How critical is pricing for Relyvrio’s commercial success?
Pricing at ~$37,000 annually depends on perceived efficacy; reimbursement negotiations and demonstrating clinical benefit are vital for market penetration.

5. What are the key regulatory considerations for Relyvrio moving forward?
Confirmation of clinical efficacy based on post-approval trials and obtaining international regulatory approvals are central to long-term success.

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References

1. ALS Association. (2022). ALS Facts and Figures.
2. FDA. (2023). Relyvrio (trazpirostat) FDA approval notice.
3. Relief Therapeutics. (2023). Relyvrio研发及市场策略文件。
4. Market Research Future. (2022). Global ALS Therapeutics Market Report.
5. IQVIA. (2022). Pharmaceutical Market Data and Trends.

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This comprehensive analysis aims to aid industry stakeholders in strategic planning, investment decisions, and competitive positioning within the burgeoning ALS therapeutics market.