List of Excipients in Branded Drug LURASIDONE HYDROCHLORIDE

Generic Drugs Containing LURASIDONE HYDROCHLORIDE

Company	Ingredient	NDC	Excipient
Major Pharmaceuticals	lurasidone hydrochloride	0904-7355	ANHYDROUS CITRIC ACID
Major Pharmaceuticals	lurasidone hydrochloride	0904-7355	CROSCARMELLOSE SODIUM
Major Pharmaceuticals	lurasidone hydrochloride	0904-7355	HYPROMELLOSE 2910
Major Pharmaceuticals	lurasidone hydrochloride	0904-7355	LACTOSE MONOHYDRATE
Major Pharmaceuticals	lurasidone hydrochloride	0904-7355	MAGNESIUM STEARATE
Major Pharmaceuticals	lurasidone hydrochloride	0904-7355	MANNITOL

What are the Most Frequently-Used Excipients in LURASIDONE HYDROCHLORIDE?

# Of NDCs	Excipient
2	ALGINIC ACID
7	ANHYDROUS CITRIC ACID
7	CARNAUBA WAX
11	CELLULOSE, MICROCRYSTALLINE
3	CITRIC ACID MONOHYDRATE
47	CROSCARMELLOSE SODIUM

Lurasidone Hydrochloride Excipient Strategy, Formulation IP, and Commercial Opportunities

Last updated: August 9, 2026

Lurasidone hydrochloride is an oral atypical antipsychotic marketed originally as Latuda by Sunovion Pharmaceuticals, a Sumitomo Pharma company. The drug is poorly water-soluble, has a clinically important food-effect requirement, and is administered as an immediate-release film-coated tablet. These characteristics create formulation opportunities in solubility enhancement, food-effect reduction, pediatric delivery, dose flexibility, and differentiated generic products.

The strongest commercial opportunity is a formulation that maintains or improves exposure without requiring patients to consume at least 350 calories with each dose. Generic tablet competition has reduced the value of simple conventional formulations, but it has also expanded demand for excipients, enabling technologies, contract development, and specialty dosage forms.

What is lurasidone hydrochloride and how is it formulated?

Lurasidone hydrochloride is the hydrochloride salt of lurasidone, a benzisothiazole-derived atypical antipsychotic. FDA approved Latuda in 2010 for schizophrenia in adults and bipolar depression associated with bipolar I disorder. Pediatric indications were added later for schizophrenia in adolescents and bipolar depression in children and adolescents.[1]

The approved product is a once-daily, immediate-release tablet. The dosage strengths are 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. Patients must take lurasidone with food containing at least 350 calories. Food increases lurasidone exposure substantially, and administration without adequate food can reduce bioavailability.[1]

Reference excipient system

Latuda tablets use a conventional wet- or dry-granulated immediate-release platform with a film coat. The FDA label identifies the following inactive ingredients:

Functional role	Representative excipients
Diluent	Mannitol
Binder and matrix former	Pregelatinized starch
Disintegrant	Croscarmellose sodium
Glidant or anti-adherent	Talc
Lubricant	Magnesium stearate
Film coating	Hypromellose, polyethylene glycol, titanium dioxide
Colorants	Iron oxide pigments, depending on strength

The commercial formulation is operationally attractive because it uses widely available, compendial excipients. It does not require a complex device, sterile manufacturing, refrigeration, or a controlled-release coating system.

What are the main physicochemical formulation challenges?

The central challenge is lurasidone’s low aqueous solubility. The molecule is highly lipophilic and behaves as a dissolution-limited compound. Tablet disintegration alone does not guarantee adequate dissolution in the gastrointestinal tract.

Three formulation risks dominate development:

1. Low and variable dissolution.
2. Dependence on a sufficiently caloric meal.
3. Dose-proportionality and bioequivalence risk across multiple strengths.

Lurasidone is generally classified as a low-solubility compound, although formal biopharmaceutic classification can depend on the regulatory framework, dose, pH range, and permeability data used. A formulation that increases apparent solubility can improve exposure, reduce interpatient variability, or weaken the food requirement.

Why the food effect matters commercially

The 350-calorie requirement creates a product-use burden. Patients with schizophrenia or bipolar depression can have irregular eating patterns, appetite changes, metabolic concerns, or difficulty following meal instructions. A product that is less food-dependent could have value even if it does not materially improve efficacy.

The food effect also creates a regulatory opportunity. A formulation that demonstrates bioequivalence under fasting conditions, or that reduces the size of the required meal, could support a differentiated product strategy. The development burden would include comparative pharmacokinetic studies under fed and fasted conditions, food-effect studies, and potentially clinical bridging.

Which excipients are most relevant to lurasidone development?

Solubility-enhancing polymers

Amorphous solid dispersions are a leading approach for poorly soluble drugs. Suitable polymers may include:

• Hypromellose acetate succinate
• Hypromellose
• Polyvinylpyrrolidone
• Copovidone
• Soluplus-type graft copolymers
• Methacrylic acid copolymers for pH-dependent release

These materials can stabilize an amorphous drug phase and improve apparent dissolution. The main risks are recrystallization during storage, high hygroscopicity, increased tablet mass, and manufacturing sensitivity.

Surfactants and wetting agents

Surfactants can improve wetting and dispersion. Common candidates include sodium lauryl sulfate, poloxamers, polysorbates, and certain lipidic surfactants. Their use must be controlled because excessive surfactant can affect tablet hardness, dissolution reproducibility, gastrointestinal tolerability, and impurity formation.

Lipid-based excipients

Self-emulsifying drug delivery systems can address a lipophilic, dissolution-limited compound. Candidate excipient classes include medium-chain triglycerides, mono- and diglycerides, polyethylene glycol glycerides, and nonionic surfactants.

A lipid-based approach could reduce reliance on a meal by providing an internal solubilization environment. It may be more suitable for softgels, liquid-filled capsules, or lipid-containing granules than for a conventional high-dose tablet.

Cyclodextrins and complexing agents

Cyclodextrin complexes can increase apparent solubility and may support orally disintegrating or liquid products. The commercial limitations are excipient cost, dose loading, moisture sensitivity, and the potential need for a relatively large excipient quantity.

Disintegrants and manufacturing aids

Croscarmellose sodium, crospovidone, and sodium starch glycolate can accelerate tablet breakup. They are useful in conventional generics and immediate-release products but do not independently solve the underlying solubility problem.

Magnesium stearate concentration and blending time require control. Excessive lubrication can slow dissolution, which is particularly important for a low-solubility active ingredient.

What formulations are protected by lurasidone intellectual property?

The foundational lurasidone composition-of-matter patent estate was developed by Sumitomo Pharma and related entities. The earliest U.S. patents covering the lurasidone chemical class expired before or around the period when generic competition entered the U.S. market. Lurasidone tablets now have generic equivalents approved by FDA.

Patent categories relevant to new products

A new lurasidone product could rely on several types of formulation or use claims:

Patent category	Potential commercial subject matter
Solid-state patents	Amorphous lurasidone, crystalline forms, hydrates, solvates
Composition patents	Drug-polymer dispersions, lipid systems, cyclodextrin complexes
Process patents	Spray drying, hot-melt extrusion, granulation, coating
Dosage-form patents	Orally disintegrating tablets, multiparticulates, capsules, liquids
Method-of-use patents	Reduced food requirement, adherence improvement, patient subgroups
Combination patents	Lurasidone with another psychiatric active ingredient
Manufacturing patents	Controlled particle size, impurity reduction, scale-up processes

A formulation patent is commercially stronger when it covers a necessary product characteristic rather than a narrow laboratory process. Claims directed only to a specific polymer ratio or one manufacturing parameter can be vulnerable to design-around strategies.

How strong is the remaining patent estate?

For conventional lurasidone hydrochloride tablets, the original composition-of-matter barrier has been overtaken by generic entry. The remaining opportunity lies in new formulation claims, not in extending exclusivity for the basic active ingredient.

Patent strength depends on:

• Demonstrated superiority in dissolution or exposure
• Evidence of reduced food effect
• Stability of the claimed solid state
• Narrowness of the excipient and process limitations
• Ability to detect infringement from public product information
• Freedom to operate around earlier lurasidone and formulation patents

The most defensible estate would combine composition claims, process claims, and claims tied to a measurable clinical or pharmacokinetic advantage.

What is the FDA and Orange Book status of lurasidone?

FDA approved Latuda as a prescription tablet and listed it in the Orange Book with the relevant drug product and patent information. The original regulatory exclusivity periods have expired, and FDA has approved abbreviated new drug applications for lurasidone hydrochloride tablets.

Regulatory issue	Current commercial implication
New drug application	Latuda approved by FDA
Dosage form	Immediate-release film-coated tablet
Strengths	20, 40, 60, 80, and 120 mg
Food requirement	At least 350 calories
Generic pathway	ANDA approvals available
Orange Book role	Lists reference product, therapeutic equivalence information, and patent data
Biologic status	Not applicable; lurasidone is a small molecule
Biosimilar risk	None

For new lurasidone formulations, the likely regulatory pathway depends on the degree of change. A conventional tablet may use the ANDA pathway if it matches the reference product in active ingredient, dosage form, strength, route, and relevant performance requirements. A materially different dosage form or formulation may require a 505(b)(2) application.

When did lurasidone lose exclusivity and when did generic entry occur?

Latuda’s market exclusivity ended after the expiration or resolution of its key patent and regulatory protections. Generic lurasidone products entered the U.S. market in 2023 following patent litigation and settlement activity involving the reference product sponsor and generic applicants.

The practical exclusivity timeline is:

Period	Event
2010	FDA approval of Latuda
2013	Expansion of approved bipolar depression use
2017	Pediatric expansion for bipolar depression
2018	Pediatric expansion for schizophrenia
2022	Major U.S. patent and generic-entry disputes reached resolution
2023	Generic lurasidone launched or became commercially available in the U.S.
Current market	Conventional tablet competition is established

The exact commercial launch date can vary by applicant, strength, market channel, and settlement terms. The strategic point is that the basic tablet market is no longer protected by branded exclusivity.

Which companies are competing in lurasidone?

The original brand was developed and commercialized by Sunovion Pharmaceuticals, now part of Sumitomo Pharma. Generic competition includes multiple ANDA sponsors and distributors, including large global generic manufacturers and U.S. specialty suppliers.

Competitive differentiation is shifting from active-ingredient ownership to:

• Supply reliability
• Low-cost manufacturing
• Broad strength coverage
• State Medicaid and managed-care contracting
• Authorized generic arrangements
• Tablet appearance and packaging
• Dose flexibility
• Specialty formulations
• Reduced food-effect products

A generic company with only a standard immediate-release tablet competes primarily on price and supply. A company with an improved formulation can pursue a higher-value 505(b)(2) strategy, subject to clinical and regulatory requirements.

What commercial opportunities exist for excipient suppliers?

Excipient suppliers can participate at several points in the lurasidone value chain.

Solubility-enhancement platforms

Suppliers of spray-dried dispersion polymers, surfactants, and lipid excipients can target developers seeking to reduce food dependence. The value proposition must include manufacturability, physical stability, and predictable dissolution, not merely higher in vitro solubility.

Pediatric dosage forms

Lurasidone already has pediatric indications, creating a rationale for child-friendly dosage forms. Potential products include:

• Orally disintegrating tablets
• Mini-tablets
• Sprinkle capsules
• Powder-for-reconstitution
• Oral suspensions
• Taste-masked granules

Taste masking is a material issue because lurasidone is an active pharmaceutical ingredient with an unpleasant sensory profile. Ion exchange resins, polymer coatings, lipid barriers, and multiparticulate systems could be used.

Adherence-oriented products

An orally disintegrating tablet could improve administration for patients with swallowing difficulty or poor adherence. It would not automatically eliminate the caloric requirement. A commercial claim based on easier administration would require appropriate clinical and regulatory support.

Manufacturing efficiency

Low-cost generic products may benefit from direct compression, continuous manufacturing, reduced coating time, lower lubricant usage, or improved powder flow. Excipients that support robust direct compression and rapid disintegration can reduce manufacturing cost and batch variability.

What manufacturing and IP barriers affect lurasidone products?

The principal manufacturing barriers are API particle engineering, content uniformity, dissolution control, and solid-state stability.

Lurasidone formulations may be sensitive to:

• API particle-size distribution
• Milling-induced amorphization
• Moisture uptake
• Polymer-drug miscibility
• Spray-drying solvent selection
• Blend segregation
• Lubrication level
• Film-coat weight
• Storage-related recrystallization

A formulation that uses amorphous lurasidone may require stronger controls than a conventional crystalline API. Developers must also assess residual solvents, polymorphic conversion, degradation products, and dissolution after accelerated stability testing.

Freedom-to-operate analysis should cover lurasidone salt forms, particle engineering, solid dispersions, lipid systems, pediatric dosage forms, and manufacturing processes. Existing patents from the innovator and third parties can overlap even after the main product patent has expired.

What generic launch risks exist for lurasidone?

Generic applicants face several risks:

1. Demonstrating bioequivalence across all marketed strengths.
2. Matching dissolution profiles despite low drug solubility.
3. Managing the food-effect requirement.
4. Maintaining tablet color and appearance across strengths.
5. Avoiding formulation patents that remain enforceable.
6. Securing reliable API supply.
7. Competing in a price-driven market after multiple entrants.
8. Managing psychiatric-product shortages and channel inventory.

Paragraph IV challenges were central to the U.S. generic-entry process. Once generic applicants asserted invalidity or noninfringement against Orange Book-listed patents, litigation and settlement terms determined the timing of launch. Because generic lurasidone is already available, future challenges are more relevant to improved formulations, new dosage forms, or secondary patents than to the original tablet.

How does lurasidone compare with competing antipsychotics?

Product	Main formulation issue	Food requirement	Differentiation opportunity
Lurasidone	Low solubility and food effect	At least 350 calories	Reduced-food formulations, pediatric delivery
Ziprasidone	Food-dependent absorption	Substantial meal requirement	Adherence and caloric-burden reduction
Aripiprazole	Generally flexible administration	No comparable caloric requirement	Lower-cost and long-acting products
Quetiapine	Multiple release profiles	Generally less restrictive	Extended-release and liquid products
Cariprazine	Low-dose capsule product	No 350-calorie requirement	Long half-life and dose flexibility
Brexpiprazole	Conventional tablet	No comparable caloric requirement	Formulation and combination strategies

Lurasidone’s competitive weakness is the meal requirement. Its potential advantages include once-daily dosing, established use in schizophrenia and bipolar depression, and a mature safety and clinical evidence base. A formulation that improves administration without increasing pill burden would address a clear product limitation.

What revenue exposure remains after generic entry?

Latuda was a major commercial product for Sumitomo Pharma before generic competition. Generic entry places pressure on price, volume, and market share. Revenue exposure is concentrated in the conventional oral tablet franchise, while potential upside shifts toward:

• New formulations
• Geographic licensing
• Authorized generics
• Pediatric products
• Specialty distribution
• Contract manufacturing
• Excipient and drug-delivery partnerships

A reformulated product must justify development and commercialization costs against rapid generic erosion. The highest-value target is a clinically meaningful reduction in the food requirement, followed by a pediatric or adherence-oriented dosage form.

Key Takeaways

• Lurasidone hydrochloride is a poorly soluble, food-effect-sensitive atypical antipsychotic.
• The reference product uses conventional excipients, including mannitol, pregelatinized starch, croscarmellose sodium, talc, magnesium stearate, and film-coating materials.
• Basic lurasidone tablet exclusivity has ended, and generic products are available.
• The strongest formulation opportunity is a solubility-enhanced product with reduced dependence on a 350-calorie meal.
• Amorphous solid dispersions, lipid systems, cyclodextrins, and particle-engineered APIs are relevant development platforms.
• Pediatric and adherence-oriented products could support a 505(b)(2) strategy.
• Excipient suppliers should prioritize physical stability, manufacturability, taste masking, and food-effect reduction.
• New patent value is likely to reside in formulation, solid-state, process, dosage-form, and method-of-use claims.
• Biosimilar competition is irrelevant because lurasidone is a small molecule.
• Generic competition makes supply reliability and manufacturing cost as important as formulation performance.

FAQs

Can lurasidone hydrochloride be formulated as an oral liquid?

Yes. An oral liquid could use suspension technology, solubilization, cyclodextrin complexation, or a lipid-based system. Taste masking, dose uniformity, chemical stability, and preservative selection would determine commercial feasibility.

Which excipient is most likely to reduce the lurasidone food effect?

No single excipient guarantees elimination of the food effect. Polymer dispersions, lipid-based systems, surfactants, and particle-engineered API platforms are the most relevant approaches because they can improve dissolution and maintain drug in a solubilized state.

Is an orally disintegrating lurasidone tablet automatically exempt from the food requirement?

No. Changing the administration route within the oral cavity does not establish food independence. A developer would need pharmacokinetic evidence under fasting and fed conditions.

Can a lurasidone formulation receive new patent protection after generic entry?

Yes. New patents may cover a novel solid form, excipient composition, dosage form, manufacturing process, or clinically supported method of use. The claims must be novel, nonobvious, enabled, and commercially enforceable.

Does lurasidone have biosimilar exposure?

No. Lurasidone hydrochloride is a chemically synthesized small molecule. Competitors use the generic-drug ANDA pathway rather than the biosimilar pathway.

References

1. U.S. Food and Drug Administration. (2024). Latuda (lurasidone hydrochloride) prescribing information.
2. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
3. U.S. Food and Drug Administration. (2010). FDA approves Latuda for schizophrenia.
4. Sumitomo Pharma Co., Ltd. (2024). Latuda product information and corporate disclosures.
5. U.S. Patent and Trademark Office. (2024). Patent Center and Patent Public Search records for lurasidone-related patents.
6. U.S. Food and Drug Administration. (2023). Approved drug products and abbreviated new drug application records for lurasidone hydrochloride tablets.