Sodium phenylbutyrate; taurursodiol - Generic Drug Details

What are the generic sources for sodium phenylbutyrate; taurursodiol and what is the scope of patent protection?

Sodium phenylbutyrate; taurursodiol is the generic ingredient in one branded drug marketed by Amylyx and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium phenylbutyrate; taurursodiol has sixty-five patent family members in twenty-five countries.

Summary for sodium phenylbutyrate; taurursodiol

International Patents:	65
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	sodium phenylbutyrate; taurursodiol at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for sodium phenylbutyrate; taurursodiol

Constraining patent/regulatory exclusivity:

TREATMENT OF AMYOTROPHIC LATERAL SCLEROSIS (ALS) IN ADULTS

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.

Anatomical Therapeutic Chemical (ATC) Classes for sodium phenylbutyrate; taurursodiol

A16AX	Various alimentary tract and metabolism products
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for sodium phenylbutyrate; taurursodiol

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
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No			Y
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
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No			Y

International Patents for sodium phenylbutyrate; taurursodiol

Country	Patent Number	Title	Estimated Expiration
Australia	2014242123
Australia	2019200658
Australia	2021201770
Australia	2022221410
Australia	2025201758

Supplementary Protection Certificates for sodium phenylbutyrate; taurursodiol

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1758590	2017C/063	Belgium		PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
2563920	CA 2019 00001	Denmark		PRODUCT NAME: A COMPOUND COMPRISING A MODIFIED OLIGONUCLEOTIDE HAVING A NUCLEOBASE SEQUENCE CONSISTING OF 20 LINKED NUCLEOSIDES ACCORDING TO EP B1 2563920 CLAIM 1 (SEQ ID NO: 80), ...SPECIFICALLY INOTERSEN; AND ITS DERIVATIVES, INCLUDING SODIUM SALTS ...; REG. NO/DATE: EU/1/18/1296 20180710
1874117	SPC/GB14/041	United Kingdom		PRODUCT NAME: DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, INCLUDING DOLUTEGRAVIR SODIUM; REGISTERED: UK EU/1/13/892/001-006 20140121
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 Sodium Phenylbutyrate and Taurursodiol

Last updated: February 20, 2026

What Are Sodium Phenylbutyrate and Taurursodiol?

Sodium phenylbutyrate (SPB) is an ammonia scavenger used primarily in urea cycle disorders. It functions by facilitating nitrogen excretion, reducing hyperammonemia risks. Taurursodiol (also known as tauroursodeoxycholic acid or TUDCA) is a bile acid derivative utilized off-label for neurological diseases, with emerging interest in neurodegenerative indications. Both compounds have seen recent attention due to their potential therapeutic applications beyond traditional uses.

What Is the Current Market Landscape?

Sodium Phenylbutyrate

• Traditional Use: Approved for urea cycle disorders (UCD) in the U.S. (FDA approval in 1996).
• Market Size (2022): Estimated at $250 million globally.
• Key Markets: United States, Europe, Japan.
• Main Manufacturers: Orphan drug status granted to several manufacturers, including Recordati and Bochemie.
• Pricing: Approximately $10,000 to $15,000 per patient annually.
• Off-label Use: Investigated for neurodegenerative and metabolic diseases; limited commercialization outside UCD.

Taurursodiol

• Traditional Use: Approved as a dietary supplement in the U.S. and Europe.
• Investigational Use: Gaining research interest as a therapeutic for amyotrophic lateral sclerosis (ALS), with clinical trials ongoing.
• Market Size (2022): Estimated at $35 million, primarily driven by dietary supplement sector.
• Key Players: Carrick Therapeutics, Amylyx Pharmaceuticals (receiving attention for ALS treatment development).
• Pricing: Dietary supplement price points: $20 to $50 per bottle; experimental drug pricing under development.

What Are the Key Drivers and Barriers?

Drivers

• Unmet Medical Need: Few therapies exist for certain neurodegenerative diseases; potential for expansion.
• Regulatory Incentives: Orphan drug designations facilitate market exclusivity and tax benefits.
• Clinical Trial Results: Positive outcomes in preliminary trials for neuroprotection and neurodegeneration.
• Expansion of Indications: Investigations into indications like Alzheimer’s disease, ALS, and other neurological conditions.

Barriers

• Limited Commercial Data: Sparse sales data outside primary indications.
• Manufacturing Complexity: Both compounds require high-purity synthesis, limiting large-scale production.
• Market Penetration: Limited awareness among physicians outside niche specialties.
• Regulatory Challenges: Need for extensive clinical validation; potential for failure in late-stage trials.

How Are Financial Trajectories Evolving?

Sodium Phenylbutyrate

• Revenue Trends: Stable in its primary indictment for UCD. Slight growth driven by expanded access programs and off-label use research.
• Investment: Pharma companies exploring reformulations and combinations for broader metabolic or neurodegenerative indications.
• Forecast (2023–2028): Compound annual growth rate (CAGR) estimated at 3-4%, contingent on regulatory approvals for new indications.

Taurursodiol

• Market Penetration: Growing due to increasing research in ALS and neurodegenerative disorders.
• Revenue Projections: Increases expected as clinical trial outcomes mature; early-stage revenue from dietary supplement sales estimated at $35 million in 2022.
• Investment Trends: Several biotech companies are advancing formulation improvements and seeking regulatory approval.

What Are the Competitive Dynamics?

• Patent Status: Limited patent protection for existing formulations; new formulations/enhanced delivery systems serve as potential patent avenues.
• Generic Competition: Presence of generics for sodium phenylbutyrate; however, orphan status provides market exclusivity.
• Pipeline Activity: Active pipelines for both drugs focus on new indications, with Taurursodiol attracting significant research investments.

What Are the Regulatory Outlooks?

• Sodium Phenylbutyrate: Maintains orphan drug designation; no recent major regulatory changes.
• Taurursodiol: Undergoing pivotal trials for neurodegenerative diseases; expected NDA submissions in 2024–2025, depending on trial outcomes.

How Do Pricing and Reimbursement Landscape Look?

Drug	Market	Price Range	Reimbursement Status
Sodium phenylbutyrate	U.S., Europe, Japan	$10,000–$15,000/year	Covered under rare disease programs
Taurursodiol (prescription)	Emerging indications	Under development	Pending regulatory approval

Reimbursement depends heavily on country-specific orphan drug policies and clinical efficacy demonstration.

Final Analysis

Sodium phenylbutyrate remains a niche, established treatment with stable revenues. Its growth is limited by competition from other ammonia scavengers and limited indication breadth. Taurursodiol presents a nascent but expanding opportunity driven by research into neurodegenerative disorders. Clinical trial success could trigger rapid revenue growth, with early commercialization in dietary supplement form translating into initial revenue streams.

Key Takeaways

• Sodium phenylbutyrate’s market is stable, with growth tied to new indication approvals.
• Taurursodiol’s revenue prospects depend on clinical trial outcomes, with potential in neurodegeneration.
• Patent strategies and formulation improvements are critical to extending market exclusivity.
• Regulatory pathways support orphan indications but pose challenges for broader approvals.
• Revenue growth will depend on clinical success, market penetration, and regulatory approvals for new intellectual property.

FAQs

1. What are the primary indications for sodium phenylbutyrate?
Urea cycle disorders, certain metabolic conditions, and investigational uses for neurodegenerative diseases.

2. How competitive is the market for taurursodiol?
Limited competition currently; increasing research activity and clinical trials could alter market dynamics.

3. What factors influence pricing for these drugs?
Orphan status, production costs, indication breadth, and reimbursement policies.

4. Are there significant patent risks for these compounds?
Limited patent life for original formulations; innovation in delivery and new indications offer patent opportunities.

5. What are the key regulatory hurdles ahead?
Demonstrating efficacy in neurodegenerative indications for taurursodiol; for sodium phenylbutyrate, expanding beyond orphan indications may require extensive trials.

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Sources

1. Food and Drug Administration. (1996). FDA Approves Drug for Urea Cycle Disorder.
2. MarketWatch. (2022). Orphan drug market data.
3. ClinicalTrials.gov. (2023). Taurursodiol clinical studies.
4. IQVIA Data. (2022). Pharmaceutical sales and pricing.
5. European Medicines Agency. (2022). Regulatory pathways for neurodegenerative drugs.