List of Excipients in Branded Drug PERAMPANEL

Generic Drugs Containing PERAMPANEL

Company	Ingredient	NDC	Excipient
Teva Pharmaceuticals Inc	perampanel	0480-7062	CELLULOSE, MICROCRYSTALLINE
Teva Pharmaceuticals Inc	perampanel	0480-7062	CROSPOVIDONE
Teva Pharmaceuticals Inc	perampanel	0480-7062	FERRIC OXIDE RED
Teva Pharmaceuticals Inc	perampanel	0480-7062	FERRIC OXIDE YELLOW

What are the Most Frequently-Used Excipients in PERAMPANEL?

# Of NDCs	Excipient
2	ANHYDROUS CITRIC ACID
2	CARBOXYMETHYLCELLULOSE SODIUM
4	CELLULOSE, MICROCRYSTALLINE
1	CROSPOVIDONE

Perampanel Excipient Strategy and Commercial Opportunities

Last updated: August 11, 2026

Perampanel is a commercially established antiseizure medicine marketed by Eisai as Fycompa. Its main excipient opportunities are pediatric and geriatric administration, taste-masked liquids, orally disintegrating or sprinkle formulations, improved dissolution, and lower-cost generic manufacturing. The marketed dosage forms use a conventional immediate-release tablet platform and a 0.5 mg/mL oral suspension, leaving room for differentiated delivery systems if they can demonstrate bioequivalence, dose uniformity, stability, and acceptable tolerability.

What is perampanel and how is it commercialized?

Perampanel is a selective, noncompetitive antagonist of AMPA-type glutamate receptors. Fycompa is approved in the United States for partial-onset seizures in patients aged 4 years and older and for primary generalized tonic-clonic seizures in patients aged 12 years and older, as adjunctive therapy.[1]

Attribute	Perampanel commercial profile
Active ingredient	Perampanel
Brand	Fycompa
Originator	Eisai Co., Ltd.
Drug class	Antiseizure medicine; AMPA receptor antagonist
U.S. NDA	202834
Dosage forms	Immediate-release film-coated tablets; oral suspension
Tablet strengths	2, 4, 6, 8, 10, and 12 mg
Oral suspension	0.5 mg/mL
Controlled-substance status	Schedule III in the United States
Administration	Once daily, generally at bedtime
Primary commercial markets	Epilepsy, chronic maintenance therapy, pediatric and adult neurology

Perampanel’s once-daily dosing supports adherence, while its long half-life and central nervous system activity impose a narrow tolerability and titration profile. Excipients that accelerate absorption or increase peak exposure would require particular scrutiny because dizziness, somnolence, irritability, aggression, and other neuropsychiatric events are clinically relevant label risks.[1]

What excipients are used in Fycompa tablets and oral suspension?

The U.S. prescribing information identifies different excipient systems for the tablet and liquid products. Formulations can differ by jurisdiction and manufacturing site, so regulatory submissions must be tied to the applicable product label and chemistry, manufacturing, and controls documentation.

Fycompa film-coated tablets

The tablet core uses a conventional direct-compression or wet-granulation excipient architecture. Listed inactive ingredients include lactose monohydrate, low-substituted hydroxypropyl cellulose, povidone, crospovidone, and magnesium stearate. The film coating contains hypromellose, talc, titanium dioxide, and strength-dependent colorants.[1]

The functional roles are straightforward:

Excipient or class	Likely formulation function
Lactose monohydrate	Diluent and tablet-mass builder
Low-substituted hydroxypropyl cellulose	Binder and disintegration aid
Povidone	Binder
Crospovidone	Superdisintegrant
Magnesium stearate	Lubricant
Hypromellose	Film former
Talc	Anti-tacking and coating aid
Titanium dioxide and colorants	Opacity and product identification

The tablet strategy is optimized for dose flexibility across six strengths rather than for modified release or advanced solubilization. A generic manufacturer can likely compete through conventional immediate-release processing, but must control blend uniformity, tablet hardness, disintegration, dissolution, coating appearance, and impurity formation.

Fycompa oral suspension

The marketed oral suspension is supplied at 0.5 mg/mL. The liquid dosage form is commercially important because it enables administration to children and patients who cannot swallow tablets. The formulation uses a suspension vehicle with viscosity control, sweetening, buffering or pH adjustment, preservation, and flavoring functions.[1]

The key technical issue is not simply keeping perampanel suspended. The product must deliver a consistent dose after storage, shaking, withdrawal through the supplied oral syringe, and repeated opening. Critical attributes include:

• sedimentation rate and redispersibility;
• particle-size distribution;
• delivered volume and syringe compatibility;
• preservative effectiveness;
• microbial limits;
• viscosity across storage temperatures;
• flavor and mouthfeel;
• dose recovery after partial bottle use;
• chemical stability in the presence of flavor and preservative systems.

For a generic or differentiated liquid, the excipient system is a major development variable. A suspension that is physically stable but difficult to redisperse can create dose variability and regulatory risk.

What excipient strategies offer the strongest commercial opportunity?

The strongest opportunities are dosage-form improvements that solve a defined administration problem without materially changing perampanel exposure.

1. Pediatric taste-masked suspension

Pediatric epilepsy is the clearest excipient-driven opportunity. Perampanel has a low daily dose relative to many liquid medicines, which allows a concentrated formulation such as 0.5 mg/mL. A competing product could target:

• improved cherry or fruit flavor;
• reduced bitterness and aftertaste;
• lower viscosity for easier syringe withdrawal;
• reduced sedimentation;
• a preservative system with better global acceptability;
• a smaller bottle and lower fill volume;
• compatibility with enteral feeding tubes.

Taste masking can use polymeric coating, ion-exchange resins, cyclodextrin complexes, lipid-based barriers, or flavor-sweetener systems. Ion exchange is less attractive unless perampanel’s physicochemical properties support stable complexation without delaying release. A simple flavor system is easier to scale but may be insufficient if bitterness persists at the dose volume.

2. Alcohol-free and excipient-minimized liquid

A liquid product with a short, globally acceptable excipient list could compete in pediatric hospitals, specialty pharmacies, and markets with restrictions on ethanol or certain preservatives. The commercial value would depend on demonstrating equivalent dose delivery and acceptable stability without relying on formulation components that create regional labeling or procurement barriers.

An alcohol-free product is not automatically differentiated under U.S. generic rules. It becomes commercially meaningful when it improves pediatric acceptability, supports feeding-tube administration, or reduces supply-chain complexity across jurisdictions.

3. Orally disintegrating tablet

An orally disintegrating tablet could address patients with dysphagia, developmental disabilities, or acute administration difficulties. The main technical constraints are:

• maintaining dose uniformity at low strengths;
• avoiding excessive friability;
• achieving rapid disintegration without a gritty mouthfeel;
• masking perampanel’s taste;
• preserving stability under humidity exposure;
• demonstrating comparable exposure to the reference product.

Potential excipients include mannitol, crospovidone, co-processed excipients, porous carriers, flavor systems, and taste-masking polymers. Mannitol may improve mouthfeel, but its hygroscopicity and compression behavior require control. A rapidly disintegrating formulation can create a useful product profile without necessarily changing the pharmacokinetic target.

4. Sprinkle or capsule-opening formulation

A multiparticulate product could permit administration over soft food, yogurt, or enteral nutrition. It would need protection against premature release, segregation, and dose loss on the food vehicle. The formulation must establish:

• uniform recovery from the capsule or sachet;
• no unacceptable interaction with food;
• no clinically meaningful change in exposure;
• chemical and physical stability after opening;
• validated instructions for administration.

This opportunity is commercially attractive for caregivers, but the development burden is higher than for a conventional tablet because the product must control particle distribution and food-contact performance.

5. Dissolution-enhanced immediate-release tablet

Perampanel is a low-dose active ingredient with limited aqueous solubility. A formulation using a surfactant, wetting agent, micronized API, co-precipitate, or amorphous solid dispersion could improve dissolution. The commercial case is strongest if dissolution is variable under relevant gastrointestinal conditions or if a new dosage form must achieve reliable exposure.

Potential approaches include:

• particle-size reduction;
• surfactant-assisted wetting;
• polymer-based amorphous dispersion;
• cyclodextrin complexation;
• lipid or self-emulsifying systems;
• porous carrier systems.

The risk is that improved dissolution can increase peak concentration or alter food effects. Because perampanel has central nervous system adverse effects and a long half-life, a formulation that changes exposure may require more than a conventional bioequivalence package.

How does perampanel’s excipient strategy compare with competing antiseizure drugs?

Perampanel is less differentiated by excipient technology than several competing antiseizure products. Levetiracetam has widely available oral solutions, tablets, and intravenous products. Lamotrigine has chewable and dispersible products. Valproate has liquids, delayed-release tablets, extended-release tablets, and sprinkle capsules. Lacosamide has tablets, oral solution, and intravenous formulations.

Drug	Common differentiated dosage forms	Commercial implication for perampanel
Levetiracetam	Tablet, oral solution, injection	Strong generic competition across administration routes
Lamotrigine	Immediate-release, extended-release, chewable/dispersible	Sets a higher standard for flexible pediatric administration
Valproate	Syrup, solution, delayed-release, extended-release, sprinkle	Broad formulation benchmark, but more complex safety profile
Lacosamide	Tablet, oral solution, injection	Competes in focal epilepsy with liquid and hospital-use options
Perampanel	Film-coated tablet, oral suspension	Opportunity remains in ODT, sprinkle, tube-compatible, and improved taste-masked products

Perampanel’s once-daily schedule is a commercial advantage, but its psychiatric and behavioral warnings make dose control and patient acceptability important. Excipients should support administration without creating rapid-release behavior or excessive peak exposure.

What regulatory pathway applies to generic perampanel formulations?

A conventional generic tablet can generally pursue an abbreviated new drug application if it matches the reference product in active ingredient, dosage form, strength, route, and other required characteristics. The applicant must demonstrate pharmaceutical equivalence and bioequivalence and address the applicable U.S. patent certifications listed in the Orange Book.[2]

A materially different formulation may require a different pathway:

Product concept	Likely U.S. pathway
Conventional immediate-release tablet	ANDA, subject to equivalence and patent requirements
Same-strength oral suspension with different excipients	Usually ANDA if pharmaceutical equivalence and bioequivalence are established
Orally disintegrating tablet	ANDA only if it fits applicable product-equivalence requirements; otherwise potential 505(b)(2)
Sprinkle multiparticulate product	Potential ANDA or 505(b)(2), depending on reference-product equivalence
Modified-release formulation	Often 505(b)(2) or a new drug application strategy
New route or clinically distinct delivery system	505(b)(2) or full NDA pathway

A 505(b)(2) strategy can create a differentiated product with new labeling or administration claims, but it may also trigger additional clinical, pharmacokinetic, food-effect, stability, and human-factors studies.

What is the Orange Book and patent status of Fycompa?

Fycompa is listed in the FDA Orange Book under NDA 202834. Orange Book analysis should distinguish the active-ingredient patent, formulation or method-of-use patents, pediatric exclusivity, and any unexpired regulatory exclusivity.[2]

The original perampanel compound patent is associated with Eisai and has been central to the product’s U.S. exclusivity history. Patent term, patent-term adjustment, pediatric exclusivity, and listed patent status must be checked against the current Orange Book entry and FDA approval history before a launch date is modeled. A Paragraph IV filing can create litigation exposure and a 30-month stay under the Hatch-Waxman framework if the relevant conditions are met.

For an excipient-driven product, the principal patent risks are usually not the excipient names themselves. Risk is more likely to arise from claims covering:

• a specific liquid formulation;
• particle-size limits;
• taste-masking architecture;
• suspension stability;
• a dosage regimen;
• a particular patient population;
• administration with food or through a feeding tube;
• manufacturing controls that define the final product.

A new formulation should therefore be screened against both composition claims and functional claims. A formulation that avoids the listed excipient may still infringe a claim defined by concentration, particle size, pH, viscosity, dissolution, or stability performance.

Which companies are challenging perampanel exclusivity?

Generic competition is expected to focus first on conventional tablets because they have the lowest development and manufacturing complexity. Potential participants include established generic companies with CNS portfolios and contract development and manufacturing organizations that can produce low-dose, high-potency solid oral products.

The most commercially relevant competitive categories are:

1. conventional tablets in all approved strengths;
2. oral suspension suppliers;
3. low-cost international manufacturers;
4. differentiated pediatric products;
5. specialty-pharmacy suppliers with packaging or adherence services.

A Paragraph IV challenge can accelerate market entry but exposes the filer to patent litigation and possible damages. An authorized generic or settlement agreement could alter the entry timetable, price erosion, and channel access. Public analysis should rely on FDA approval records, Orange Book certifications, PACER litigation records, and company disclosures rather than on promotional statements.

What manufacturing and intellectual-property barriers affect excipient commercialization?

Perampanel is potent at low dose, making content uniformity and segregation major manufacturing concerns. The most important process controls are:

• API particle-size distribution;
• geometric dilution and blend sampling;
• lubricant mixing time;
• tablet compression force;
• coating weight gain;
• suspension particle-size control;
• bottle and syringe dose delivery;
• preservative distribution;
• cleaning validation for potent CNS compounds.

For liquid products, container-closure selection is commercially important. A bottle that adsorbs perampanel, leaches extractables, or causes poor syringe withdrawal can undermine an otherwise acceptable formulation. For pediatric use, child-resistant packaging and accurate dosing devices are part of the product proposition.

Excipient supply is another potential barrier. Crospovidone, low-substituted hydroxypropyl cellulose, specialty coating materials, flavors, and suspension stabilizers can face supplier qualification or regional availability constraints. A dual-source strategy is valuable for a generic launch, especially where the formulation depends on a narrow viscosity grade or proprietary flavor.

How strong is the perampanel formulation opportunity?

The formulation opportunity is moderate rather than transformational.

Opportunity	Technical difficulty	Commercial attractiveness	IP potential
Conventional generic tablet	Low to moderate	High volume, price-driven	Low unless process or formulation claims apply
Improved oral suspension	Moderate	High in pediatrics and dysphagia	Moderate
Taste-masked liquid	Moderate to high	High if tolerability improves	Moderate to high
Orally disintegrating tablet	High	Moderate to high	Moderate
Sprinkle or tube-compatible product	High	Targeted but defensible	High
Amorphous or lipid-based formulation	High	Unclear unless exposure improves	High
Modified-release product	Very high	Potentially meaningful, but clinically complex	High

The best near-term commercial strategy is a differentiated oral suspension or ODT with a clear administration benefit. A new formulation should preserve once-daily dosing, avoid increased peak exposure, and support pediatric labeling. A conventional tablet is more suitable for a cost-leadership strategy than for premium pricing.

What revenue exposure and launch scenarios exist for perampanel?

Perampanel revenue is exposed to generic entry across six tablet strengths and the oral suspension. Tablets will likely experience faster price erosion because multiple manufacturers can use established immediate-release platforms. The oral suspension may retain a narrower specialty market if it requires more complex stability, taste, packaging, and device work.

Launch scenario	Expected market effect
Single generic tablet entrant	Moderate price reduction; brand may retain specialty share
Multiple tablet entrants	Rapid price erosion and channel substitution
Generic suspension entrant	Additional pediatric and caregiver pressure
Authorized generic	Earlier price competition with controlled supply
ODT or sprinkle entrant	Targeted share capture rather than full substitution
Taste-masked pediatric product	Potential premium in specialty and hospital channels

Commercial success will depend on more than formulation novelty. Reimbursement placement, wholesaler access, controlled-substance distribution requirements, pediatric labeling, and reliable supply will determine whether a differentiated excipient product earns a premium.

Key Takeaways

• Perampanel’s marketed formulation is a conventional immediate-release tablet plus a 0.5 mg/mL oral suspension.
• The highest-value excipient opportunities are taste masking, ODT delivery, sprinkle administration, enteral-tube compatibility, and suspension stability.
• Conventional tablets are likely to face the most intense generic price competition.
• A differentiated liquid can defend value if it improves pediatric acceptability, dose accuracy, or administration.
• Formulation development must control peak exposure because perampanel has clinically important CNS and behavioral adverse effects.
• Patent analysis should cover composition, concentration, particle size, dissolution, stability, administration, method-of-use, and manufacturing claims.
• A 505(b)(2) pathway may be appropriate for materially differentiated dosage forms, while conventional tablets and equivalent suspensions generally fit the ANDA framework.

FAQs

Can perampanel be reformulated as an orally disintegrating tablet?

Yes. The formulation would need to demonstrate acceptable taste, rapid disintegration, dose uniformity, stability, and bioequivalence or otherwise support a 505(b)(2) application.

Which excipient is most important in a perampanel suspension?

The suspension-stabilizing system is central because it controls sedimentation, redispersibility, syringe delivery, and dose uniformity. Flavor, preservative, and viscosity systems are also commercially important.

Is a lactose-free perampanel tablet commercially attractive?

Potentially, but the opportunity is limited unless lactose intolerance, allergy concerns, or regional procurement requirements create measurable demand. A lactose-free formulation must preserve compression, disintegration, stability, and bioequivalence.

Could a perampanel liquid be administered through a feeding tube?

It may be possible, but tube compatibility must be demonstrated. Studies should assess dose recovery, adsorption, clogging, dilution, flushing, and stability after contact with the device and administration vehicle.

What is the best patent strategy for a new perampanel excipient formulation?

The strongest strategy combines composition claims with measurable performance limits, such as particle size, viscosity, dissolution, redispersibility, taste-masking structure, stability, or dose-delivery accuracy. Claims limited only to routine excipient substitution are more vulnerable to obviousness challenges.

References

1. Eisai Inc. (2023). Fycompa (perampanel) tablets and oral suspension: U.S. prescribing information. U.S. Food and Drug Administration labeling database.

2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA Center for Drug Evaluation and Research.

3. U.S. Food and Drug Administration. (2024). Drugs@FDA: Fycompa, NDA 202834. FDA Center for Drug Evaluation and Research.

4. U.S. Food and Drug Administration. (2024). Guidance for industry: Bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA. FDA Center for Drug Evaluation and Research.