UCEPHAN Drug Patent Profile

Which patents cover Ucephan, and when can generic versions of Ucephan launch?

Ucephan is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in UCEPHAN is sodium benzoate; sodium phenylacetate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the sodium benzoate; sodium phenylacetate profile page.

Summary for UCEPHAN

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for UCEPHAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
B Braun	UCEPHAN	sodium benzoate; sodium phenylacetate	SOLUTION;ORAL	019530-001	Dec 23, 1987		DISCN	No	No

International Patents for UCEPHAN

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

Country	Patent Number	Title	Estimated Expiration
Canada	1175750	METHODE POUR ELIMINER LES DECHETS AZOTES (PROCESS FOR WASTE NITROGEN REMOVAL)

Supplementary Protection Certificates for UCEPHAN

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	LUC00195	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((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-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; 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
1856135	2020/017	Ireland		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTRATION NO/DATE: EU/1/19/1405 20200113
2203431	1590018-6	Sweden		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1912999	1490062-5	Sweden		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
1499331	SPC/GB13/034	United Kingdom		PRODUCT NAME: IZINOVA CONCENTRATE FOR ORAL SOLUTION. THE ACTIVE SUBSTANCE IS A MIXTURE OF 3 SALTS:SODIUM SULPHATE ANHYDROUS, MAGNESIUM SULPHATE HEPTAHYDRATE AND POTASSIUM SULPHATE.; REGISTERED: BE BE434323 20130220; UK PL34926/0016 20130313

Overview and Market Context

Last updated: February 3, 2026

UCEPHAN is an investigational or marketed pharmaceutical featuring a specific active ingredient or therapeutic profile. Without detailed proprietary or public patent filings, it’s impossible to precisely characterize UCEPHAN’s molecule, indication, or regulatory status. For analysis, assume UCEPHAN targets a prevalent condition with high unmet medical needs, potentially in oncology, neurology, or infectious diseases—common focus areas for new pharmacotherapies.

Patent and IP Landscape

Patent protection is critical for investment security in pharmaceuticals. Typically, a new drug's patent lasts 20 years from the filing date, with 10-12 years of effective market exclusivity. Key factors include:

• Patent Filing Date: Early filing enhances market exclusivity (e.g., a patent filed in 2020 would expire around 2040).
• Patent Claims Robustness: Broad claims covering the molecule, formulation, or use extend protection.
• Supplementary Protections: Data exclusivity (usually 5 years in the US, 10 in the EU) offers additional market barriers beyond patents.

If UCEPHAN is still in development, securing composition-of-matter patents and process patents remains strategic. Patent litigation risks exist, especially if competing firms develop similar compounds or biosimilars.

Regulatory and Development Milestones

• Preclinical Data: Toxicology, pharmacokinetics, and efficacy in models.
• Clinical Trials: Phase I (safety, dosage), Phase II (efficacy, dosing), Phase III (large population safety and efficacy).
• Regulatory Submission: NDA (US), MAA (EU), rolling reviews possible.
• Approval Timing: Based on typical timelines, UCEPHAN could reach approval 8-12 years post-initiation, depending on regulatory complexity and data robustness.

Accelerated approval pathways, such as Breakthrough Therapy or Priority Review, can shorten timeframes if UCEPHAN addresses unmet needs.

Market Dynamics and Competitive Landscape

• Market Size: For a prevalent condition, the global addressable market can range from $1 billion to over $10 billion.
• Competitors: Established therapies with patents expiring soon or biosimilars pose competition. Innovator drugs with strong data and safety profiles retain market share.
• Pricing Strategy: Pricing varies with indication severity, treatment duration, and competitive pressure. High-value therapies (e.g., oncology drugs) often command premium pricing ($100k+ annually).

Investment Fundamentals

• Development Cost: Estimated at $2.6 billion from preclinical to launch, referencing industry averages (PhRMA, 2022).
• Time to Market: 8-12 years, with risk of delays in clinical phases.
• Revenue Potential: Revenue estimates depend on market penetration, pricing, and duration of exclusivity.

Assuming successful approval and commercialization, revenue projections for a niche but high-value UCEPHAN could reach hundreds of millions annually, with blockbuster potential if indicated for broad, unmet needs. Break-even point often occurs 10-15 years after initial R&D investment.

Key Investment Risks

• Regulatory rejection or delays.
• Scientific failure or safety concerns.
• Competitive entry from biosimilars or generics.
• Pricing pressures and payer restrictions.

Financial and Strategic Considerations

• Licensing and Partnerships: Partnering with larger pharma firms can mitigate risk and provide funding.
• Market Access: Early engagement with payers influences reimbursement prospects.
• Intellectual Property: Continuous patent filings and defenses safeguard market exclusivity.

Conclusion

Investment in UCEPHAN hinges on the developmental stage, regulatory pathway, patent position, competitive landscape, and commercial feasibility. A thorough due diligence includes examining late-stage clinical data, patent filings, and potential market size.

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Key Takeaways

• UCEPHAN's future depends on successful clinical results, patent protection, and approval timelines.
• Market potential varies based on indication unmet needs, competition, and pricing.
• Development costs are high, with a typical timeline of nearly a decade to market.
• Strategic partnerships can accelerate progression and de-risk investment.
• Regulatory, scientific, and market risks remain significant.

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FAQs

1. What determines UCEPHAN’s commercial viability?
Market size, competitive landscape, regulatory approval chances, and reimbursement prospects influence viability.

2. How does patent protection impact investment?
Strong patents secure market exclusivity, enabling price control and recoupment of R&D expenses.

3. What are key stages in UCEPHAN’s development?
Preclinical studies, clinical trials (Phases I-III), regulatory review, and commercialization.

4. How do regulatory pathways affect timeframes?
Accelerated pathways can reduce time to approval but require meeting specific criteria related to unmet needs or orphan status.

5. What are primary risk factors in investing in UCEPHAN?
Clinical failure, regulatory setbacks, patent challenges, and market competition.

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Sources
[1] PhRMA. (2022). Biopharmaceutical Industry Profile.