List of Excipients in Branded Drug LATUDA

Company	Tradename	Ingredient	NDC	Excipient	Potential Generic Entry
Sumitomo Pharma America Inc	LATUDA	lurasidone hydrochloride	63402-302	CARNAUBA WAX
Sumitomo Pharma America Inc	LATUDA	lurasidone hydrochloride	63402-302	CROSCARMELLOSE SODIUM
Sumitomo Pharma America Inc	LATUDA	lurasidone hydrochloride	63402-302	HYPROMELLOSE 2910
Sumitomo Pharma America Inc	LATUDA	lurasidone hydrochloride	63402-302	MAGNESIUM STEARATE
Sumitomo Pharma America Inc	LATUDA	lurasidone hydrochloride	63402-302	MANNITOL
Sumitomo Pharma America Inc	LATUDA	lurasidone hydrochloride	63402-302	STARCH, CORN

Latuda Excipient Strategy and Commercial Opportunities After Generic Entry

Last updated: August 9, 2026

Latuda, the branded lurasidone hydrochloride product developed by Sumitomo Pharma, is an immediate-release film-coated tablet with a central formulation constraint: it must be taken with at least 350 calories to achieve adequate exposure. That food requirement creates the strongest commercial opportunity for excipient suppliers, generic manufacturers, and reformulation developers. The branded product’s U.S. market exclusivity ended in 2023, and generic lurasidone products entered under settlement arrangements. The commercial focus has therefore shifted from protecting the original tablet to improving food independence, swallowability, pediatric administration, dose flexibility, and manufacturing economics.

What is Latuda and how is it formulated?

Latuda contains lurasidone hydrochloride, an atypical antipsychotic approved for schizophrenia and bipolar depression. The U.S. product is supplied as immediate-release tablets in 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg strengths.[1]

The marketed tablet uses a conventional direct-compression or dry-granulation excipient architecture:

Component	Functional role
Mannitol	Diluent; contributes to tablet bulk and mouthfeel
Pregelatinized starch	Binder, filler, and disintegration support
Croscarmellose sodium	Superdisintegrant
Hypromellose	Film coating and tablet protection
Magnesium stearate	Lubricant
Titanium dioxide and iron oxides	Colorants
Film-coating materials	Appearance, identification, and moisture protection

The exact excipient composition varies by strength and coating color. FDA labeling and DailyMed should control any commercial comparison of the reference product’s inactive ingredients.[1,2]

Latuda is not an extended-release product, depot injection, biologic, or combination product. Its principal formulation challenge is oral absorption rather than prolonged release.

Why does Latuda require at least 350 calories?

Latuda must be administered with at least 350 calories because food materially increases lurasidone exposure. The FDA label reports higher exposure when lurasidone is taken with food compared with fasting conditions.[1]

The food effect creates several technical and commercial consequences:

1. Patients may take the dose without sufficient food.
2. Exposure may vary between treatment days.
3. Evening administration can be inconvenient for patients with irregular meal patterns.
4. Generic manufacturers must demonstrate bioequivalence under the FDA’s required fed and fasting study conditions.
5. A formulation that reduces food dependence could have clinical and commercial value even after patent expiry.

The food effect is therefore the most attractive target for excipient-led innovation. A conventional blend of mannitol, starch, croscarmellose sodium, and magnesium stearate is unlikely by itself to eliminate the requirement. A successful food-independent formulation would probably require changes in drug particle engineering, wetting, solubilization, supersaturation control, or lipid-associated delivery.

What excipient strategies are available for lurasidone?

Particle-size reduction and wetting enhancement

Lurasidone is a poorly water-soluble compound. Micronization or nanocrystal technology can increase surface area and improve dissolution. Candidate excipient systems include:

• Poloxamers
• Sodium lauryl sulfate at controlled levels
• Polyvinylpyrrolidone
• Copovidone
• Hydroxypropyl cellulose
• Hydroxypropyl-beta-cyclodextrin
• Sulfobutylether-beta-cyclodextrin
• Surfactant-lipid combinations

The commercial advantage is a potentially lower dependence on bile-mediated solubilization after meals. The development risk is physical instability, including particle growth, aggregation, and changes in dissolution during storage.

Amorphous solid dispersions

An amorphous solid dispersion can improve apparent solubility by dispersing lurasidone in a polymeric carrier. Relevant polymers include:

• HPMC-AS
• Povidone
• Copovidone
• Soluplus
• Polyvinyl alcohol
• HPMC

Amorphous systems may produce a stronger food-effect reduction than a standard crystalline tablet. Their main barriers are hygroscopicity, recrystallization, residual solvent control, and scale-up. A formulation patent covering a polymer-drug ratio, manufacturing process, or dissolution profile could remain commercially useful even when the original Latuda patents have expired.

Lipid-based systems

Self-emulsifying drug delivery systems, solid lipid dispersions, and lipid-coated particles are relevant because food normally supplies lipids and stimulates bile secretion. A lipid-based lurasidone formulation could replicate part of the fed-state environment.

Potential excipients include:

• Medium-chain triglycerides
• Long-chain glycerides
• Oleic acid
• Caprylocaproyl macrogol glycerides
• Polysorbates
• Phospholipids
• Gelucire-type lipid excipients

The principal commercial risk is capsule or softgel processing complexity, chemical stability, dose uniformity, and the need to prove that the formulation does not create a new exposure profile or safety concern.

Co-processed excipients and direct compression

For commodity generic tablets, the commercial objective is usually lower cost and robust high-speed manufacture rather than differentiated pharmacokinetics. Co-processed mannitol, starch, and superdisintegrant systems can improve:

• Flowability
• Content uniformity
• Compactability
• Tablet tensile strength
• Disintegration time
• Defect rates during coating

These systems are most relevant to generic manufacturers seeking a lower-cost process that remains close to the reference product.

Orodispersible and pediatric formulations

An orally disintegrating tablet could address swallowing difficulty and reduce dependence on water. Mannitol-based ODT systems are commercially attractive because mannitol provides a cooling mouthfeel and acceptable palatability. Other relevant excipients include crospovidone, low-substituted hydroxypropyl cellulose, flavor systems, and taste-masking polymers.

An ODT would not automatically solve the 350-calorie requirement. It would need separate pharmacokinetic evidence if positioned as food-independent or suitable for administration without a meal.

Liquid suspensions, multiparticulates, and sprinkle formulations could target pediatric and geriatric use. Lurasidone’s approved pediatric indication increases the value of dosage forms that support flexible administration, although any new presentation would require regulatory approval and clinical bridging.

What patents protect Latuda and its formulation?

Latuda’s historical U.S. protection consisted of lurasidone compound, formulation, and method-of-use rights, together with FDA regulatory exclusivities. The original compound protection and later Orange Book-listed rights supported branded exclusivity through the early 2020s.

Protection category	Commercial relevance
Lurasidone compound patents	Protected the active pharmaceutical ingredient and core molecule
Solid-state or salt rights	Could restrict particular crystalline forms or lurasidone hydrochloride preparations
Tablet formulation rights	Could cover excipient combinations, manufacturing parameters, or dissolution properties
Method-of-use patents	Covered schizophrenia and bipolar depression treatment concepts
Pediatric exclusivity	Added six months to applicable periods after FDA pediatric-study completion
Orange Book listings	Established the patent certifications required for abbreviated new drug applications

FDA-approved generic applicants generally address listed patents through Paragraph I, II, III, or IV certifications. Paragraph IV certifications assert that a listed patent is invalid, unenforceable, or will not be infringed. Public generic-entry records indicate that lurasidone applicants challenged the remaining U.S. protection and entered settlement arrangements that permitted generic availability before or around the final branded exclusivity endpoint.[3,4]

The original Latuda estate is no longer the main barrier to generic entry. New patent value would instead come from differentiated products, including:

• Food-independent formulations
• ODTs
• Pediatric suspensions
• Multiparticulate or sprinkle dosage forms
• Long-acting injectable formulations
• New solid forms
• Manufacturing processes that reduce impurity formation
• Drug-excipient complexes
• Specific dissolution or pharmacokinetic profiles

A new formulation patent must be drafted around measurable technical features. Broad claims covering routine use of common excipients would face substantial validity and obviousness risk.

When did Latuda lose U.S. exclusivity?

U.S. generic lurasidone entry began in 2023 under agreements with generic manufacturers. Sumitomo Pharma reported the loss of exclusivity as a material commercial event for Latuda, with revenue declining sharply after generic competition began.[4,5]

The relevant exclusivity sequence was:

Period	Event
2010	FDA approved Latuda for schizophrenia
2013	FDA expanded approval to bipolar depression
2014-2015	Pediatric development and regulatory exclusivity became relevant
2023	Generic lurasidone entered the U.S. market
2024 onward	Multiple generic suppliers competed on price, supply, and contracting

The precise timing for each generic manufacturer depended on settlement terms, FDA approval timing, and supply arrangements. FDA’s Orange Book and Drugs@FDA records remain the controlling regulatory sources for current listings and approval status.[3]

What is the Orange Book status of Latuda?

Latuda is an FDA-approved small-molecule tablet product listed in the Orange Book. It is not eligible for biosimilar competition because lurasidone is a synthetic small molecule rather than a biologic.

Orange Book relevance is concentrated in:

• Listed patents
• Patent expiration dates
• Approved dosage strengths
• Reference-product status
• Generic applicant certifications
• Therapeutic-equivalence codes

An Orange Book listing does not prevent a generic from filing an ANDA. It determines the patent-certification pathway and may trigger Paragraph IV litigation. After listed patents expire or are successfully addressed, generic applicants can obtain approval if they meet FDA quality and bioequivalence requirements.

Which companies are challenging or competing with Latuda?

The U.S. competitive field includes generic manufacturers that obtained approval for lurasidone tablets. Public market participants have included large generic companies and specialty suppliers such as Teva, Zydus, and other ANDA holders identified in FDA approval records and litigation filings.[3,6]

Competition is based on:

• Wholesale acquisition price
• Medicaid and managed-care contracting
• Manufacturing reliability
• Strength availability
• Pharmacy-channel substitution
• Authorized-generic arrangements
• Ability to maintain supply during price erosion

Brand Latuda can retain limited demand through prescriber familiarity, continuity of care, payer positioning, and patient support programs. Those advantages generally weaken as therapeutic substitution expands.

What formulation patents could create new commercial opportunities?

Food-independent lurasidone

This is the highest-value formulation concept. A product that produces consistent exposure without a 350-calorie meal could support a new product profile, particularly if clinical data show improved adherence or reduced exposure variability.

Long-acting injectable lurasidone

A depot formulation would target adherence and could compete with long-acting injectable antipsychotics. Excipient opportunities include biodegradable polyesters, suspending agents, viscosity modifiers, and depot-forming polymers. The development burden would be much higher than for an oral reformulation because of injection-site tolerability, release kinetics, sterility, and device requirements.

Pediatric liquid or sprinkle formulations

These products could address administration barriers without directly competing with low-cost generic tablets. Excipients must meet pediatric safety, palatability, preservative, and dose-uniformity requirements.

Fixed-dose combinations

A combination product with another psychiatric agent could create new intellectual property, but it would face complex clinical, regulatory, and commercial questions. Combination claims must show a credible therapeutic rationale rather than merely co-administering known drugs.

How strong is the Latuda patent estate after generic entry?

The legacy patent estate has limited ability to block standard lurasidone tablets after generic launch. Its residual strength is highest for specific formulations or manufacturing processes that are not required to practice the basic generic product.

Estate segment	Post-generic strength
Core lurasidone molecule	Low, due to expiry
Standard immediate-release tablet	Low to moderate, depending on unexpired claims
Food-independent formulation	Potentially high if clinically differentiated
ODT or liquid formulation	Moderate to high if claims are specific and non-obvious
Long-acting injectable	Potentially high, but development intensive
Manufacturing process	Moderate if it produces a measurable quality advantage
Method of use	Limited unless tied to a new indication or patient population

Patent strength depends on claim scope, written description, enablement, prior art, prosecution history, and whether the product requires the claimed feature. A patent covering an optional excipient is commercially weaker than one covering a necessary composition or process limitation.

What generic launch risks exist for lurasidone?

Generic entry creates four principal risks for the branded product:

1. Rapid price erosion in pharmacy channels.
2. Formulary substitution and loss of preferred status.
3. Reduced physician sensitivity to brand formulation differences.
4. Lower commercial return from incremental indications without new exclusivity.

Generic manufacturers face different risks:

• Lurasidone’s food effect complicates bioequivalence testing.
• Poor aqueous solubility can produce dissolution variability.
• Multiple strengths increase manufacturing and inventory complexity.
• Color and coating differences can create product-identification issues.
• Supply interruptions can trigger regulatory scrutiny and commercial penalties.

For excipient suppliers, these risks create demand for robust, reproducible materials rather than novel chemistry alone. A supplier that can reduce tablet variability, improve dissolution control, or support a food-independent formulation has a clearer value proposition than a supplier offering an undifferentiated filler.

What is the revenue exposure from Latuda’s patent loss?

Latuda was a major revenue contributor for Sumitomo Pharma before generic entry. Company filings reported a substantial decline in Latuda sales after loss of exclusivity, consistent with the rapid erosion typically seen for oral small-molecule antipsychotics.[4,5]

Revenue exposure is concentrated in:

• U.S. sales
• High-dose strengths
• Commercial insurance and Medicaid volume
• Chronic maintenance therapy
• Brand prescriptions that convert through automatic substitution

The commercial value of a new formulation depends on whether it can obtain separate regulatory exclusivity, secure reimbursement, and demonstrate a benefit that prescribers and payers recognize. An excipient change without a clinically meaningful product advantage is unlikely to support premium pricing after generic entry.

How does Latuda compare with competing antipsychotics?

Product	Active ingredient	Formulation opportunity	Generic or biosimilar risk
Latuda	Lurasidone	Food-independent tablet, ODT, liquid, depot	Generic competition; no biosimilar pathway
Vraylar	Cariprazine	Long-acting or modified-release systems	Future generic risk after patent expiry
Rexulti	Brexpiprazole	ODT, depot, pediatric dosage forms	Future generic risk
Abilify Maintena	Aripiprazole	Depot delivery and injection-device improvements	Generic or follow-on injectable risk
Caplyta	Lumateperone	Solubility enhancement and modified oral delivery	Patent-protected branded competition

Latuda’s distinctive formulation weakness is the calorie requirement. That gives reformulation developers a clearer technical target than products whose main differentiation is already based on extended release or depot delivery.

What licensing and partnership opportunities exist?

The most credible licensing targets are platform technologies rather than basic excipient supply contracts. Relevant deal structures include:

• Licensing nanocrystal or amorphous-dispersion technology
• Contract development of a food-independent tablet
• Co-development of a pediatric liquid
• Regional rights for a reformulated lurasidone product
• Manufacturing partnerships for specialty dosage forms
• Excipient supply agreements linked to formulation patents

Sumitomo Pharma’s historical commercialization structure involved its U.S. subsidiary Sunovion, which commercialized Latuda in the United States. Following generic entry, licensing value is more likely to arise from a differentiated follow-on product than from continued exclusivity for the original tablet.[4]

Key Takeaways

• Latuda contains lurasidone hydrochloride in an immediate-release film-coated tablet.
• The key formulation issue is the requirement to take the product with at least 350 calories.
• Mannitol, pregelatinized starch, croscarmellose sodium, hypromellose, and magnesium stearate support the conventional tablet design.
• U.S. generic lurasidone entry began in 2023, materially reducing the value of the original product estate.
• The strongest post-generic opportunities are food-independent formulations, ODTs, pediatric liquids, multiparticulates, and long-acting injectables.
• Biosimilar risk does not apply because lurasidone is a small-molecule drug.
• New patent value will depend on specific composition, process, pharmacokinetic, or clinical-use claims.
• Excipient suppliers have the clearest commercial opportunity where their materials improve dissolution, stability, dose uniformity, palatability, or food independence.

FAQs

Can lurasidone be reformulated as a food-independent tablet?

Yes. The technical route would likely involve particle engineering, amorphous dispersion, lipid-based delivery, or a solubilizing excipient system. The reformulated product would require pharmacokinetic evidence demonstrating acceptable exposure without the current calorie requirement.

Are Latuda’s excipients protected by patents?

The use of common excipients such as mannitol, starch, croscarmellose sodium, and magnesium stearate is generally not proprietary by itself. Patent protection may apply to specific ratios, processing conditions, particle characteristics, dissolution profiles, or combinations that produce a measurable technical effect.

Does a lurasidone ODT avoid the food requirement?

Not automatically. Faster disintegration improves administration but does not necessarily eliminate the food effect. A food-independent ODT would require separate formulation and clinical support.

Is there a biosimilar version of Latuda?

No. Lurasidone is a synthetic small molecule regulated through the ANDA generic-drug pathway, not the biosimilar pathway under the Public Health Service Act.

What is the most valuable excipient opportunity for lurasidone?

A formulation that reduces or eliminates the 350-calorie administration requirement has the highest strategic value. Lower-cost co-processed excipient systems are more practical for generic manufacturers but offer less opportunity for premium pricing.

References

1. U.S. Food and Drug Administration. (2024). Latuda (lurasidone hydrochloride) prescribing information.
2. National Library of Medicine. (2024). DailyMed: Latuda, lurasidone hydrochloride tablet, film coated.
3. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
4. Sumitomo Pharma Co., Ltd. (2024). Annual report and financial results materials.
5. Sunovion Pharmaceuticals Inc. (2023). Latuda product and market information.
6. U.S. Food and Drug Administration. (2024). Drugs@FDA: Lurasidone hydrochloride abbreviated new drug applications.