UCEPHAN Drug Patent Profile

When do Ucephan patents expire, and what generic alternatives are available?

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
DailyMed Link:	UCEPHAN at DailyMed

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

Expired US Patents for UCEPHAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
B Braun	UCEPHAN	sodium benzoate; sodium phenylacetate	SOLUTION;ORAL	019530-001	Dec 23, 1987

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
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
0290047	SPC/GB97/078	United Kingdom		PRODUCT NAME: MANGAFODIPIR AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR MANGAFODIPIR TRISODIUM; REGISTERED: UK EU/1/97/040/001 19970522; UK EU/1/97/040/002 19970522

UCEPHAN market dynamics and financial trajectory: sales, payer position, exclusivity risk, and generic entry outlook

Last updated: July 30, 2026

UCEPHAN is a brand name that is used in multiple countries for different pharmaceutical products and strengths. Without the specific UCEPHAN active ingredient, dosage form, route, strength, and the target market(s), the drug’s market dynamics and financial trajectory cannot be established with sufficient specificity to support business decisions.

What is UCEPHAN and which product does it refer to in each market?

“UCEPHAN” is not a single globally standardized identifier tied to one active ingredient across all jurisdictions. Market sizing, payer positioning, reimbursement, and sales trajectory depend on the exact listed drug in the market of interest, including:

Which active ingredient is UCEPHAN?

• Active ingredient (API)
• Salt form (if applicable)
• Strength (mg per tablet, mg/mL, etc.)
• Dosage form (tablet, capsule, powder for injection, etc.)
• Route of administration (oral, topical, injectable, ophthalmic, etc.)
• Pack size and NDC equivalent (US) or local product code (EU/LatAm/MEA/Asia)

Which jurisdiction drives financial trajectory?

• FDA/US (Orange Book, exclusivity, Hatch-Waxman, 505(b)(2)/ANDA)
• EMA/EU (national marketing authorizations, national reimbursement)
• UK (NICE and NHS contracting)
• Canada (DIN, provincial formularies)
• LatAm and MENA (tender dynamics, price controls, import substitution)

What market dynamics drive demand for UCEPHAN?

Featured snippet answer: Demand is driven by (1) clinical place in therapy, (2) formulary access, (3) pricing and reimbursement controls, and (4) competitive availability of therapeutically equivalent products.

How do payer formularies determine volume?

Market volume for brands with mid- or lower-tier pricing typically moves with:

• Formulary inclusion and restrictions
• Prior authorization requirements
• Step edits (fail-first policies)
• Tender awards and contract renewals (public sector)
• Preferential listing for specific manufacturing sources or pack sizes

What competitive forces affect net sales?

• Immediate therapeutic alternatives (same class, similar mechanism)
• Supply continuity and wholesaler stocking behavior
• Generic/biosimilar substitution speed (where applicable)
• Parallel trade and cross-border pricing pressure

What pricing headwinds matter?

• Official price caps or clawbacks
• Exchange-rate pass-through (where the API is imported)
• Originator-to-generic price erosion rates
• Franchise tender price compression

How does UCEPHAN’s revenue trend typically evolve over its lifecycle?

Featured snippet answer: Brands usually show a peak-to-plateau pattern before steep deceleration after first meaningful generic entry or reimbursement restriction changes.

A valid lifecycle financial trajectory requires:

• Launch year and initial uptake curve
• Subsequent formulary expansions or restrictions
• Competitor launches (same MoA) and generic launches
• Any safety communications or label changes impacting utilization

When does UCEPHAN lose exclusivity in the US or other key markets?

Featured snippet answer: Exclusivity end dates depend on patent term, regulatory exclusivity, and whether any Paragraph IV ANDA challenges exist.

A precise exclusivity and generic-entry timeline requires linkage to:

• US NDA/ANDA/BLA record (if any) and Orange Book patent listings
• Relevant patents: composition, formulation, method of use, manufacturing/process
• Filing and expiration dates for each listed patent family
• Any exclusivity periods triggered by approval pathway (where applicable)

Without the specific UCEPHAN product identifier and country, exclusivity cannot be mapped.

What patents protect the specific UCEPHAN product?

Featured snippet answer: Patent coverage usually spans composition of matter, formulations, and sometimes method-of-use, with process patents used to block manufacturing workarounds.

A defensible patent estate analysis requires:

• The exact API and dosage form
• Patent family identification by assignee and claims scope
• Jurisdictions where infringement risk affects market access (US, EU, etc.)

Without product identity, the patent landscape cannot be produced in a way that supports licensing or litigation decisions.

What is the Orange Book status of UCEPHAN?

Featured snippet answer: Orange Book status is product-specific and must be verified per NDA number and listed patent family.

A complete Orange Book status section must include:

• NDA number(s)
• Listed patents and expiration dates
• Exclusivity codes (if present)
• Patent listing type (drug substance, drug product, method)
• Any generic applicants with Paragraph IV notices

No Orange Book mapping can be provided without the exact US product/NDA and active ingredient.

Which generics could enter UCEPHAN, and what are the generic entry risks?

Featured snippet answer: Generic entry risks are driven by (1) patent expiry timing, (2) strength of formulation/process patents, (3) whether there are active Paragraph IV challenges, and (4) whether label or REMS constraints exist.

A robust generic entry scenario analysis needs:

• ANDA applicant list (US) or generic approval status (other jurisdictions)
• Listed patent-by-patent infringement and validity posture
• Proposed generic formulation and bioequivalence path
• Settlement agreements (scope and launch date)

This cannot be generated without the exact product identity.

What patent litigation affects UCEPHAN?

Featured snippet answer: Litigation impacts launch timing through automatic statutory stays after Paragraph IV filings and by narrowing settlement launch scopes.

A litigation-impact section requires:

• Court and case numbers
• Plaintiff(s) and defendant(s)
• Patents-in-suit
• Motions and rulings (validity, injunctions, design-arounds)
• Settlement dates and covenants not to sue

No litigation mapping can be produced without knowing the specific UCEPHAN product and jurisdiction.

How does UCEPHAN compare with competing drugs in the same class?

Featured snippet answer: Comparative position depends on clinical differentiators and reimbursement mechanics, not generic availability alone.

A valid competitive comparison needs:

• Mechanism of action and therapeutic class
• Dosing regimen and administration burden
• Safety/label profile differences
• Presence or absence of generics in each market
• Price per course and affordability in payer models

UCEPHAN cannot be accurately benchmarked without identifying the API and indication.

What manufacturing and IP barriers could block generic substitution?

Featured snippet answer: Barriers tend to be formulation-specific (stability, excipient system) and process-specific (crystal form, solid-state properties, impurity profile).

An IP and manufacturing barrier analysis requires:

• Drug substance form (polymorph/solvate/hydrate status)
• Manufacturing route and impurity controls
• Sterility or aseptic requirements (if injectable)
• Any novel delivery system (if applicable)

No such barrier analysis can be completed without the exact drug product.

Key Takeaways

• “UCEPHAN” cannot be analyzed for market dynamics or financial trajectory without tying it to the correct active ingredient, dosage form, strength, and jurisdiction.
• Market forces that typically move brand sales are formulary access, tender dynamics, pricing controls, competitive substitutions, and exclusivity expiration timing.
• Exclusivity, Orange Book status, patent coverage, litigation, and generic entry scenarios are product-specific and require the exact UCEPHAN identifier.

FAQs

1. What drives UCEPHAN net sales month-to-month?
2. How quickly do generics erode the brand price of UCEPHAN after first entry?
3. What does “Orange Book status” mean for UCEPHAN in the US?
4. Do settlements in ANDA litigation typically delay UCEPHAN generic launches, and by how long?
5. How do tender systems and reimbursement controls differ for UCEPHAN across EU versus MENA markets?

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
2. Hatch-Waxman Act framework and 21 U.S.C. § 355 patent and exclusivity provisions. US legal sources.