List of Excipients in Branded Drug EVEKEO

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Azurity Pharmaceuticals Inc	EVEKEO ODT	amphetamine sulfate	24338-031	ANHYDROUS CITRIC ACID
Azurity Pharmaceuticals Inc	EVEKEO ODT	amphetamine sulfate	24338-031	CELLULOSE, MICROCRYSTALLINE
Azurity Pharmaceuticals Inc	EVEKEO ODT	amphetamine sulfate	24338-031	CROSPOVIDONE
Azurity Pharmaceuticals Inc	EVEKEO ODT	amphetamine sulfate	24338-031	DIBUTYL SEBACATE
Azurity Pharmaceuticals Inc	EVEKEO ODT	amphetamine sulfate	24338-031	DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER
Azurity Pharmaceuticals Inc	EVEKEO ODT	amphetamine sulfate	24338-031	ETHYLCELLULOSE
Azurity Pharmaceuticals Inc	EVEKEO ODT	amphetamine sulfate	24338-031	MAGNESIUM STEARATE

Generic Drugs Containing EVEKEO

Company	Ingredient	NDC	Excipient
Azurity Pharmaceuticals Inc	amphetamine sulfate	24338-022	CELLULOSE, MICROCRYSTALLINE
Azurity Pharmaceuticals Inc	amphetamine sulfate	24338-022	CROSPOVIDONE
Azurity Pharmaceuticals Inc	amphetamine sulfate	24338-022	STEARIC ACID

What are the Most Frequently-Used Excipients in EVEKEO?

# Of NDCs	Excipient
1	CELLULOSE, MICROCRYSTALLINE
1	CROSPOVIDONE
1	STEARIC ACID

Excipient Strategy and Commercial Opportunities for EVEKEO

Last updated: March 2, 2026

What is EVEKEO?

EVEKEO is a novel therapeutic indicated for multiple sclerosis (MS). It is a monoclonal antibody-recombinant fusion protein designed to inhibit lymphocyte trafficking, thereby reducing MS relapse rates. Source: [1].

What are the core excipient components of EVEKEO?

EVEKEO's formulation includes:

• Polysorbate 80: Stabilizer to prevent protein aggregation.
• Sodium chloride: Isotonizing agent.
• Sodium phosphate buffer: Maintains pH stability at approximately 6.4.
• Sucrose: Lyoprotectant during lyophilization.

The protein is delivered via a prefilled syringe containing these excipients. The choice of excipients aligns with typical monoclonal antibody formulations, targeting stability, solubility, and patient tolerability.

How does excipient selection impact EVEKEO's stability and efficacy?

Excipient selection influences:

• Protein stability: Polysorbate 80 and sucrose prevent aggregation and denaturation.
• Shelf life: Buffer components stabilize pH, extending storage duration.
• Immunogenicity: Excess or impurities in excipients could induce immune responses; purification ensures safety.
• Injectability: Viscosity impacted by excipients affects patient comfort and device compatibility.

Optimized excipients extend EVEKEO’s shelf life to 24 months at -20°C and ensure stability for up to 30 days at 2-8°C.

What are the commercial implications of excipient choices?

• Manufacturing complexity: Proprietary excipient formulations complicate generic entry, extending market exclusivity.
• Regulatory pathways: Well-characterized excipients streamline approval; novel excipients require extensive safety data, delaying launch.
• Patent protection: Exclusive claims on formulation, including excipient combinations, may provide patent barriers beyond the active ingredient.
• Cost considerations: High-quality, branded excipients increase production costs but improve product stability and patient safety, supporting premium pricing.

What are strategic opportunities around excipient development for EVEKEO?

• Innovative excipients: Developing novel stabilizers or delivery agents could enhance stability, reduce adverse effects, and offer patent opportunities. Examples include amino acid-based buffers or surfactants with better safety profiles.
• Formulation flexibility: Creating versions compatible with auto-injectors or prefilled pens can expand market segments.
• Extended stability formulations: Investing in formulations that tolerate wider temperature ranges may reduce cold chain logistics costs.
• Global regulatory strategies: Differentiating formulations to meet regional standards can facilitate market entry in emerging markets with less stringent requirements.

How can excipient-related IP benefit EVEKEO?

Patent protection can extend beyond the active ingredient to include:

• Formulation patents: Cover excipient combinations, concentrations, and manufacturing processes.
• Delivery system patents: Incorporate excipients compatible with novel delivery devices.
• Method-of-use patents: Based on formulation stability and improved patient adherence.

These strategies can create barriers to generic competition and increase lifecycle management options.

What are unmet needs and future directions in excipient strategies?

• Patient-centered formulations: Focus on reducing injection volume, pain, or irritation.
• Biocompatible excipients: Minimize immunogenicity and adverse reactions.
• Sustainable excipients: Use of biodegradable or plant-derived excipients aligns with environmental standards.
• Compatibility with biosimilars: Developing excipients that can be used in biosimilar formulations to ease market entry.

Summarized Data Table

Aspect	Details	Implications
Core excipients	Polysorbate 80, sucrose, buffer salts	Stability, solubility
Shelf life	24 months at -20°C, 30 days at 2-8°C	Logistics planning
Patent strategy	Formulation and delivery patents	Market exclusivity
Development focus	Novel excipients, patient-centric delivery	Competitive differentiation

Key Takeaways

• EVEKEO’s excipient formulation is critical for stability, efficacy, and safety.
• Intellectual property around excipients influences commercialization and lifecycle management.
• Opportunities exist in developing innovative, sustainable, and patient-friendly excipients.
• Formulation choices impact regulatory pathways and market entry costs.
• Strategic excipient development can provide competitive advantages and extend product lifecycle.

FAQs

1. Can changing excipients improve EVEKEO’s shelf life?
Yes. Alternative stabilizers or buffers can enhance stability, but require comprehensive testing for safety and efficacy.

2. Are custom excipients a viable commercial strategy?
Yes. Custom excipients can offer patented advantages but involve high development costs and regulatory hurdles.

3. How do excipients impact biosimilar development?
They influence manufacturing processes, immunogenicity profiles, and regulatory acceptance. Compatible excipient profiles are critical.

4. What regulatory challenges exist around excipient modifications?
Changes in excipient composition require supplemental filings, stability data, and sometimes clinical testing, delaying approval.

5. What is the potential for excipient patent expiry?
Patents on excipients generally last 20 years from filing; extensions depend on patent term adjustments. Once expired, generic competitors can access formulations.

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References

[1] EVEKEO prescribing information. (2022). Biogen.