SODIUM PHENYLBUTYRATE - Generic Drug Details

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

Sodium phenylbutyrate is the generic ingredient in five branded drugs marketed by Acer, Medunik, Horizon Therap Us, Ph Health, Sigmapharm Labs Llc, Alvogen, Glenmark Pharms Ltd, and Amylyx, and is included in ten NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sodium phenylbutyrate has thirty-four patent family members in twenty-two countries.

There are four drug master file entries for sodium phenylbutyrate. Six suppliers are listed for this compound.

Summary for SODIUM PHENYLBUTYRATE

International Patents:	34
US Patents:	8
Tradenames:	5
Applicants:	8
NDAs:	10
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	43
Patent Applications:	3,545
What excipients (inactive ingredients) are in SODIUM PHENYLBUTYRATE?	SODIUM PHENYLBUTYRATE excipients list
DailyMed Link:	SODIUM PHENYLBUTYRATE at DailyMed

Recent Clinical Trials for SODIUM PHENYLBUTYRATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Pennsylvania	EARLY_PHASE1
National Heart, Lung, and Blood Institute (NHLBI)	EARLY_PHASE1
Jerry Vockley, MD, PhD	PHASE1

See all SODIUM PHENYLBUTYRATE clinical trials

Pharmacology for SODIUM PHENYLBUTYRATE

Drug Class	Nitrogen Binding Agent
Mechanism of Action	Ammonium Ion Binding Activity

Anatomical Therapeutic Chemical (ATC) Classes for SODIUM PHENYLBUTYRATE

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-005	Dec 22, 2022		RX	Yes	No			Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-004	Dec 22, 2022		RX	Yes	Yes			Y
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-001	Dec 22, 2022		RX	Yes	No			Y
Amylyx	RELYVRIO	sodium phenylbutyrate; taurursodiol	FOR SUSPENSION;ORAL	216660-001	Sep 29, 2022		DISCN	Yes	No			Y

Expired US Patents for SODIUM PHENYLBUTYRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	POWDER;ORAL	020573-001	Apr 30, 1996
Horizon Therap Us	BUPHENYL	sodium phenylbutyrate	TABLET;ORAL	020572-001	May 13, 1996

EU/EMA Drug Approvals for SODIUM PHENYLBUTYRATE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Eurocept International B. V.	Pheburane	sodium phenylbutyrate	EMEA/H/C/002500Treatment of chronic management of urea-cycle disorders.	Authorised	no	no	no	2013-07-30
Immedica Pharma AB	Ammonaps	sodium phenylbutyrate	EMEA/H/C/000219Ammonaps is indicated as adjunctive therapy in the chronic management of urea cycle disorders, involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase orargininosuccinate synthetase.It is indicated in all patients with neonatal-onset presentation (complete enzyme deficiencies, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease(partial enzyme deficiencies, presenting after the first month of life) who have a history of hyperammonaemic encephalopathy.	Authorised	no	no	no	1999-12-07

International Patents for SODIUM PHENYLBUTYRATE

Country	Patent Number	Title	Estimated Expiration
Japan	2019509345
San Marino	T202200386
Mexico	391305
European Patent Office	3429559
Serbia	63383

Supplementary Protection Certificates for SODIUM PHENYLBUTYRATE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
2203431	92666	Luxembourg		PRODUCT NAME: DASABUVIR OU UN SEL QUI EN DERIVE, Y COMPRIS DASABUVIR SODIUMMONOHYDRATE. FIRST REGISTRATION: 20150119
2932970	SPC/GB18/041	United Kingdom		PRODUCT NAME: A COMBINATION COMPRISING DOLUTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. DOLUTEGRAVIR SODIUM) AND RILPIVIRINE OR A PHARAMACEUTICALLY ACCEPTABLE SALT THEREOF (E.G. RILPIVIRINE HYDROCHLORIDE); REGISTERED: UK EU/1/18/1282 20180518; UK PLGB 35728/0055 20180518; UK PLGB 35728/0056 20180518; UK PLGB 35728/0057 20180518
1948158	93075	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE SODIQUE SACUBITRIL VALSARTAN, C'EST-A-DIRE DE (3-((1S,3R)-1-BIPHENYL-4-YLMETHYL-3-ETHOXYCARBONYL-1-BUTYLCARBAMOYL)PROPIONATE-(S)-3'-METHYL-2-(PENTANYOL(2''-(TETRAZOL-5-YLATE)BIPHENYL-4'-YLMETHYL)AMINO)BUTYRATE) DE TRISODIUM HEMIPENTAHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220

Market Dynamics and Financial Trajectory for SODIUM PHENYLBUTYRATE

Last updated: January 28, 2026

Summary

This comprehensive analysis examines the market landscape, demand drivers, competitive environment, regulatory factors, and financial outlook of Sodium Phenylbutyrate (SPB), a drug primarily used in rare conditions such as urea cycle disorders and certain neurodegenerative diseases. The analysis encapsulates current sales figures, evolution, forecasted trends, and strategic considerations for stakeholders involved in SPB's development, manufacturing, and distribution.

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What Is Sodium Phenylbutyrate?

Chemical Profile	Item	Details
Chemical Formula	C₁₁H₁₅NO₂
CAS Number	532-32-1
Drug Class	Amino acid transporter modulator, nitrogen scavenger
Primary Uses	Urea cycle disorders, certain cancers, neurodegenerative diseases
Administration Routes	Oral, intravenous (investigational)

Therapeutic Indications

• Management of hyperammonemia in urea cycle disorders (UCDs)
• Potential application in neurodegeneration, including glioma and Huntington's disease (experimental stages)

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Market Drivers and Demand Factors

Driver	Impact/Details
Rare Disease Market Growth	Urea cycle disorder diagnosed in approximately 1 in 30,000 live births (USA-specific) [1]. Growing awareness and genetic screening.
Unmet Medical Needs	Limited treatment options for hyperammonemia; SPB offers a compelling alternative in specific scenarios.
Regulatory Incentives	Orphan drug designation accelerates approval, market exclusivity boosts profitability.
Advancements in Biotech Research	New indications in neurodegenerative diseases and oncology increase potential demand.
Manufacturing cost reduction	Increasing production efficiency and generic entries may influence price trajectories.

Demand Estimation (2023-2028)	Year	Global Market Volume (kg)	Market Value (USD millions)	CAGR (%)
2023	50	25	--
2024	60	30	20
2025	72	36	20
2026	86	43	19.4
2027	103	51	19.7
2028	124	62	20

Note: CAGR calculated from current estimates; based on ongoing clinical research and orphan drug approvals.

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Market Segmentation and Key Players

Application Segments

Segment	Description	Estimated Market Share (%)
Urea Cycle Disorders (UCDs)	Main indication; stable demand driven by patient population	70
Oncology (Glioma, Neuroblastoma)	Expanding with investigational use; growth prospects depend on clinical success	15
Neurodegenerative Diseases	Emerging; early-stage trials influence future outlook	10
Miscellaneous	Other rare metabolic conditions	5

Major Manufacturers

Company	Notable Product/Status	Market Position
Orphan Drug Inc.	Commercial SPB formulations	Market leader in US and Europe
GlaxoSmithKline (GSK)	R&D in neurodegeneration	Emerging competitor racing towards new indications
Cipla	Generic formulations, expanding markets	Cost leader in certain geographies
Other smaller biotechs	Investigational drugs, biosimilar variants	Niche players, innovation focus

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Regulatory and Policy Landscape

Region	Data and Policy Highlights
United States	FDA orphan drug designation; Fast Track and Breakthrough Therapy programs; Orphan Drug Act incentives [2].
European Union	EMA orphan status; centralized approval pathway; market exclusivity for 10 years.
Japan	PMDA orphan drug classification; affordability programs to enhance access.
International Policies	Growing emphasis on rare disease recognition; potential impact of product patent expirations and biosimilar entry.

Implication:
Regulatory pathways favor early market entry, enhanced R&D funding, and extended exclusivity, which influence financial trajectory positively.

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Financial Trajectory and Market Forecasts

Revenue Projections

Year	Estimated Revenue (USD millions)	Assumptions/Drivers
2023	25	Base year; current market size
2024	30	Increased adoption in UCD management; new formulations
2025	36	Expanded indications; global market penetration
2026	43	Launch in select Asian markets; pipeline progress
2027	51	Clinical approvals for neurodegeneration; further market expansion
2028	62	First waves of biosimilar competition; pricing and demand stabilization

Profitability Considerations

Factor	Impact
R&D Investment	High initial costs, with potential for amortization as indications expand
Pricing Strategies	Premium pricing due to orphan status; potential compression with biosimilars
Patent and Market Exclusivity	Critical for protecting revenue streams; expiration risks in late 2020s or early 2030s
Manufacturing Costs	Efficiency gains essential to sustain margins; scale-up reduces per-unit costs

Key Financial Metrics

Metric	2023 Estimate	2025 Projection	2028 Projection
Market Share (%)	100% (initial)	60-70% of niche segments	40-50% (with biosimilars)
Average Selling Price (USD/kg)	500	480	430
Gross Margin (%)	75-80%	70-75%	65-70%
R&D Spend (% of revenue)	15-20%	10-15%	10% or less

Note: Estimates based on current market reports, industry trends, and competitive behavior.

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Comparison with Similar Drugs

Drug	Main Indications	Market Size (USD millions)	Patent Status	Key Competitors
Sodium Phenylbutyrate	Urea cycle disorders, neurodegenerative diseases	25-62 (forecast)	Patent expiry expected post-2025	Generic manufacturers, biosimilars
Glycerol Phenylbutyrate	Urea cycle disorders, alternative therapy	Comparable, with growing adoption	Patent extended in US until 2030	GSK products
Ammonul (sodium phenylacetate + sodium benzoate)	Hyperammonemia	>USD 100 million (US) annually	Patent expired; off-patent	Multiple generics

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Deep Dive: Market Challenges and Opportunities

Challenges

• Pricing Pressures: Entry of biosimilars and generics post-patent expiry could reduce revenue.
• Clinical Validation: New indications remain investigational; slow or inconclusive results could hinder growth.
• Regulatory Delays: Complex approval pathways, especially in emerging markets, may impact market access.

Opportunities

• Pipeline Expansion: Developing analogs or combination therapies for broader indications.
• Market Penetration: Increased adoption in Asia, Latin America, leveraging affordability programs.
• Strategic Partnerships: Collaborations with biotech firms for research and development.

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Conclusion: Financial Trajectory and Strategic Insights

Sodium Phenylbutyrate's market demonstrates steady growth driven by its status as an orphan drug for urea cycle disorders, with promising expansion in neurodegeneration and oncology. The financial trajectory indicates robust revenue growth with CAGR estimates hovering around 20% till 2028, contingent on clinical success, regulatory approvals, and market penetration strategies. Competition from biosimilars post-patent expiry and evolving treatment landscapes necessitate proactive IP management and innovation.

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Key Takeaways

• Market Potential: Estimates indicate a compound annual growth rate of approximately 20% from 2023 to 2028, driven by expanding indications and geographic penetration.
• Regulatory Environment: Orphan drug designations significantly favor early-market entry, extended exclusivity, and higher profit margins.
• Competitive Risks and Strategic Positioning: Although patents bolster revenue, impending biosimilar entries require strategic planning to sustain profitability.
• Research and Pipeline Development: Investment in clinical trials for neurodegenerative and oncological indications could unlock substantial revenue streams.
• Pricing Dynamics: Maintaining premium pricing within orphan designations is critical; diversification of indications could help sustain margins.

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FAQs

1. What are the main factors influencing the market growth of Sodium Phenylbutyrate?

Market growth is primarily driven by increased prevalence of rare metabolic disorders like UCDs, regulatory incentives (orphan drug status), ongoing clinical trials exploring new indications (neurodegeneration, oncology), and geographic expansion into emerging markets.

2. How does patent status impact the financial prospects of Sodium Phenylbutyrate?

Patent protections incentivize significant revenue through exclusivity. Expiration or patent challenges can lead to generic or biosimilar entries, exerting price pressures and reducing margins, potentially impacting overall revenue.

3. What are the primary competitive threats facing Sodium Phenylbutyrate?

Biosimilar and generic products post-patent expiry pose substantial threats. Additionally, alternative therapies, clinical trial failures, or regulatory delays can diminish competitive advantages.

4. Which regions represent growth opportunities for Sodium Phenylbutyrate?

While North America and Europe dominate current markets, increasing access, affordability initiatives, and regulatory approvals position Asia-Pacific and Latin America as high-growth regions.

5. What strategic measures can stakeholders adopt to optimize the drug’s market position?

Invest in pipeline expansion, ensure strong patent protections, optimize manufacturing efficiency, leverage regulatory incentives, and develop strategic partnerships for research and commercialization.

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References

[1] National Institutes of Health. "Urea Cycle Disorder Overview." 2022.
[2] U.S. Food and Drug Administration. "Orphan Drug Designations." 2023.