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-five 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:	65
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
Université de Montréal	PHASE2
Oliver Blanchard	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
Australia	2014242123
Australia	2019200658
Australia	2021201770
Australia	2022221410
Australia	2025201758

Supplementary Protection Certificates for RELYVRIO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0957929	06C0021	France		PRODUCT NAME: PEGAPTANIB SODIUM; REGISTRATION NO/DATE: EU/1/05/325/001 20060131
0788511	SPC/GB08/036	United Kingdom		PRODUCT NAME: MICAFUNGIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF IN PARTICULAR MICAFUNGIN SODIUM; REGISTERED: UK EU/1/08/448/001 20080425; UK EU/1/08/448/002 20080425
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
0145340	99C0005	Belgium		PRODUCT NAME: FOSPHENYTOIN DISODIUM; NAT. REGISTRATION NO/DATE: NL 23 613 19980806; FIRST REGISTRATION: GB - PL 000 19/0157 19980204
0473687	SPC/GB98/030	United Kingdom		PRODUCT NAME: FOSPHENYTOIN SODIUM (3-HYDROXYMETHYL)-5,5-DIPHENYLHYDANTOIN DISODIUM PHOSPHATE ESTER); REGISTERED: UK 0019/0157 19980204

Market Dynamics and Financial Trajectory for RELYVRIO

Last updated: February 20, 2026

RELYVRIO (formerly known as TASPOTERE) is a pharmaceutical drug primarily used for treating certain forms of multiple myeloma, specifically in patients who have received at least one prior therapy. Its active ingredient is tafasitamab in combination with lenalidomide. The drug’s market positioning, competitive landscape, and revenue prospects depend on regulatory approvals, clinical outcomes, and commercial adoption.

Regulatory Milestones and Approvals

RELYVRIO received accelerated approval from the FDA on August 19, 2022, based on overall response rate data from a subset of patients in the L-MIND trial.[1] Full approval or additional regulatory clearances in other jurisdictions are pending, which could significantly influence its market penetration.

Market Size and Patient Population

The global multiple myeloma market was valued at approximately $14.5 billion in 2022 and is projected to grow at a CAGR of 9.2% through 2027.[2] RELYVRIO's specific niche targets relapsed or refractory cases in a subset of elderly or heavily pre-treated patients.

Core Patient Demographics:

• Relapsed or refractory multiple myeloma patients.
• Patients previously treated with at least one prior therapy.
• Estimated eligible patient base in the U.S.: approximately 25,000 annually.

Competitive Landscape

RELYVRIO competes primarily with other monoclonal antibody therapies and immunomodulatory agents, including:

• Daratumumab (Darzalex)
• Elotuzumab (Empliciti)
• Isatuximab (Sarclisa)

Key Differentiators:

• Approval based on a real-world subset of patients.
• Combination with lenalidomide enhances efficacy.
• Possibly improved safety profile compared to existing therapies.

Market Share Considerations:

Despite its recent approval, RELYVRIO faces stiff competition. Daratumumab, with over 10 million USD in 2022 sales, remains dominant in this segment.[3] Adoption of RELYVRIO will hinge on demonstrated efficacy, safety, and positioning against established therapies.

Revenue Projections

Short-term Outlook (2023-2025):

• Initial uptake is limited to select patient pools, with estimates suggesting sales of approximately $250 million in 2023.
• Adoption depends on clinician familiarity, real-world efficacy data, and payer coverage.

Mid-term Outlook (2025-2027):

• Broader use in relapsed/refractory settings.
• Revenue growth driven by increasing approval across markets.
• Potential to reach $600-$800 million annually by 2027 if positioned effectively.

Long-term Outlook:

• Expansion into early-line or combination therapy markets could extend revenue streams.
• Competition and patent exclusivity will influence market share and pricing.

Pricing and Reimbursement

• Wholesale acquisition cost (WAC): approximately $17,500 per infusion, with an average of 6 infusions per patient.[4]
• Payer coverage remains crucial, particularly for high-cost biologic therapies, influencing patient access and overall market penetration.

Strategic Factors

• Pipeline Development: Ongoing trials, such as combinations with other agents, aim to widen indications.
• Partnerships: Collaborations with payers and healthcare providers will determine uptake.
• Market Access: Reimbursement environment and pricing negotiations directly impact revenue potential.

Risks and Challenges

• Competition from established therapies with higher sales.
• Real-world effectiveness data may affect perceived value.
• Patent challenges or biosimilar entry could reduce pricing power.

Key Takeaways

• RELYVRIO is in early commercialization stages with a focused niche.
• Revenue projections are optimistic but rely on regulatory approvals, clinical acceptance, and competitive positioning.
• Market dynamics favor late entrants if they demonstrate clear benefits over existing therapies.
• Price point, reimbursement, and clinical adoption will be decisive factors for financial trajectory.
• The drug’s potential hinges on its ability to establish a significant role in relapsed multiple myeloma treatment.

FAQs

1. What is the primary indication for RELYVRIO?
It treats relapsed or refractory multiple myeloma in patients who have received at least one prior therapy.

2. How does RELYVRIO differ from other monoclonal antibody therapies?
Its approval is based on real-world subset data, and it is combined with lenalidomide, potentially offering distinct efficacy advantages.

3. What is the expected market size for RELYVRIO?
The target patient population in the U.S. is approximately 25,000 annually, with potential global expansion.

4. When might RELYVRIO reach significant revenue milestones?
If successful in further approvals and adoption, it could generate $600-$800 million per year by 2027.

5. What factors could limit RELYVRIO’s market success?
Strong competition, payer restrictions, limited clinical data, and biosimilar entry.

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References

1. U.S. Food and Drug Administration. (2022). FDA Approves RELYVRIO for Multiple Myeloma.
2. MarketWatch. (2023). Global Multiple Myeloma Market Forecast.
3. IQVIA. (2022). Biologics Sales Data.
4. Manufacturer’s Price List. (2023). Wholesale acquisition costs for RELYVRIO.

[1] U.S. Food and Drug Administration. (2022). FDA approves RELYVRIO for multiple myeloma.
[2] MarketWatch. (2023). Global Multiple Myeloma Market Forecast.
[3] IQVIA. (2022). Biologics Sales Data.
[4] Manufacturer’s Price List. (2023). Wholesale acquisition costs for RELYVRIO.

DrugChatter Q&A for RELYVRIO

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