US Patent 9,815,827: Lurasidone Low-Weight-Gain Treatment Claims, Expiration and Generic Risk

US Patent No. 9,815,827 protects specific methods of administering lurasidone, marketed as Latuda, to treat schizophrenia or manic depressive psychosis while avoiding clinically significant weight gain. The patent does not claim lurasidone as a chemical compound. It claims patient-treatment protocols involving oral, once-daily administration of 20 to 120 mg, selected dosage strengths, monotherapy, a six-week treatment period, tablet formulations, and clinical outcomes.

The patent’s commercial importance is narrower than the underlying lurasidone compound estate but broader than a conventional dosage patent because independent claims combine the drug, dose range, treatment indication and weight-related outcome. The principal validity and enforcement risks concern the meaning of “clinically significant weight gain,” whether the claimed result is inherent in administering lurasidone, and whether the claims are sufficiently supported by the specification and clinical data.

What drug and treatment does US 9,815,827 cover?

US 9,815,827 covers lurasidone, specifically the lurasidone free base or a pharmaceutically acceptable salt, principally the hydrochloride salt used in Latuda tablets.

The chemical name in the claims is a stereochemically defined form of lurasidone:

Patent subject	Covered substance
Active ingredient	Lurasidone
Common product	Latuda
Principal salt	Lurasidone hydrochloride
Dosage form	Oral pharmaceutical composition, including tablets
Dose range	20 to 120 mg per day
Administration	Once daily in many dependent claims
Indications	Schizophrenia and manic depressive psychosis
Claimed benefit	No clinically significant weight gain, or no weight gain

FDA approved Latuda for schizophrenia in adults in 2010 and later expanded the label to include bipolar depression associated with bipolar I disorder. The patent uses the older expression “manic depressive psychosis,” while the modern regulatory terminology is generally bipolar depression or bipolar I disorder.[1]

What are the independent claims in US 9,815,827?

The patent has four principal independent claim groups.

Independent claim	Core subject matter	Key limitations
Claim 1	Schizophrenia treatment	Oral lurasidone, 20-120 mg/day, without clinically significant weight gain
Claim 8	Manic depressive psychosis treatment	Oral lurasidone, 20-120 mg/day, without clinically significant weight gain
Claim 25	Antipsychotic treatment	Once-daily oral lurasidone, 20-120 mg, without clinically significant weight gain
Claim 40	Pharmaceutical composition treatment	Once-daily composition containing 20-120 mg lurasidone as sole active ingredient
Claim 56	Broader no-weight-gain treatment	Once-daily composition containing 20-120 mg lurasidone as sole active ingredient, without weight gain

Claims 1, 8 and 25 are method claims directed to administration of lurasidone. Claim 40 is a method claim that adds a pharmaceutical composition and sole-active-ingredient limitation. Claim 56 is similar but replaces “without a clinically significant weight gain” with “without a weight gain,” which is potentially broader in literal scope but may create greater enablement, definiteness and proof issues.

How broad is the claim scope?

The practical claim scope is defined by five recurring elements:

Lurasidone or a pharmaceutically acceptable salt.
Oral administration.
A 20 to 120 mg daily dose.
Treatment of schizophrenia, manic depressive psychosis or an antipsychotic-treated patient.
A specified weight-related outcome.

The claims do not cover every use of lurasidone. They do not expressly cover:

doses below 20 mg or above 120 mg;
nonoral delivery systems;
treatment of an indication outside the claimed disease categories;
combination therapy where the relevant claim requires sole active ingredient or no concurrent antipsychotic;
administration schedules outside the claimed once-daily limitations;
lurasidone formulations that do not produce the claimed clinical result.

Claims 1 and 8 require only 20 to 120 mg/day and do not require once-daily administration. Claims 7 and 19 through 24 narrow the regimen to specified once-daily doses or dose ranges. Claims 25 and 40 expressly require once-daily administration. Claims 40 through 55 also require the composition to contain lurasidone as the sole active ingredient.

The coverage is therefore strongest against a generic product that reproduces the Latuda label, supplies 20 mg, 40 mg, 60 mg, 80 mg or 120 mg tablets, and promotes the product for schizophrenia or bipolar depression.

Which dosage strengths are protected?

The dependent claims identify the commercial dose strengths used in lurasidone labeling:

Dose	Relevant claim coverage
20 mg	Claims 13, 19, 34, 51 and 67
40 mg	Claims 7, 14, 20, 35, 52, 68 and 69
60 mg	Claims 15, 21, 36, 53, 70 and 71
80 mg	Claims 16, 22, 37, 54 and 72
120 mg	Claims 17, 23, 38, 55, 74 and 75
20, 40, 60, 80 or 120 mg	Claims 18, 24, 39, 50 and 66

The claims cover both a continuous range of 20 to 120 mg and the five specified commercial strengths. A generic sponsor could not necessarily avoid the claims by selecting one of the listed strengths, because the patent expressly claims each of them.

What formulations are protected by US 9,815,827?

The formulation coverage is limited but commercially relevant.

Claims 40 through 55 require:

a pharmaceutical composition;
20 to 120 mg of lurasidone or its salt;
oral, once-daily administration;
lurasidone as the sole active ingredient;
in some dependent claims, a tablet;
in several claims, lurasidone hydrochloride.

The claims do not recite excipients, dissolution specifications, particle size, polymorph characteristics, coating systems or manufacturing steps. They are therefore not conventional formulation-composition claims. They are treatment claims that use a pharmaceutical composition as an administration vehicle.

A tablet containing lurasidone hydrochloride as the only active ingredient is the clearest commercial embodiment. A capsule or another oral dosage form could fall within claims 40 or 56 if the remaining limitations are met, even though claims 42 and 58 specifically identify a tablet.

What does “clinically significant weight gain” mean?

The phrase is central to infringement and validity analysis. The claim text supplied does not define a numerical threshold for “clinically significant weight gain.” The claims also do not identify a particular statistical test, patient population, baseline body weight, observation period, comparator or percentage change.

The specification and prosecution history would control how a court construes the phrase. The six-week limitation appears in claims 3, 10, 27, 43 and 59. It may provide an objective time point, but it does not itself establish the amount of weight gain that is clinically significant.

This creates several litigation issues:

A generic label may not expressly promise absence of clinically significant weight gain.
Infringement may depend on clinical evidence rather than label language alone.
A patentee may argue that the claimed result is inherent when the approved regimen is administered.
An accused manufacturer may argue that “clinically significant” is indefinite or that the result is not reliably achieved across the full dose range.
Claim 56’s “without a weight gain” language could be challenged as requiring an absolute absence of weight increase, a difficult clinical standard.

Claims that require only administration “such that” the patient does not experience the result may also create proof problems. The claim language focuses on the treatment outcome, not merely the physician’s intent.

Does the patent cover monotherapy?

Yes. Several claims expressly narrow the treatment to monotherapy or sole-active-ingredient use.

Claims 4, 12, 32 and 33 require treatment without concurrently administering another antipsychotic medication. Claims 40 through 55 require lurasidone as the sole active ingredient in the pharmaceutical composition. Claims 56 through 75 use the same sole-active-ingredient structure.

The monotherapy limitations are narrower than the independent claims. A lurasidone product used with another antipsychotic could remain within claims 1, 8 or 25 if the other limitations are satisfied, but it would fall outside claims that expressly prohibit concurrent antipsychotic therapy.

What does the BPRS limitation add?

Claim 6 requires a patient with a Brief Psychiatric Rating Scale score of at least 42 and a significant reduction from baseline.

This limitation narrows claim 1 to a defined severity population and a measured treatment response. The BPRS element can strengthen the argument that the claim is tied to a clinically tested population, but it also makes infringement more difficult to establish because a generic manufacturer ordinarily does not control the prescribing physician’s baseline BPRS score or later clinical measurement.

The claim may have limited practical value against an ANDA applicant unless the proposed labeling, clinical study design or instructions direct use in patients meeting the BPRS limitation.

When does US 9,815,827 expire?

Public patent records identify US 9,815,827 as a Sunovion Pharmaceuticals patent issued on November 14, 2017. The patent is associated with an earlier lurasidone development and patent family focused on treatment methods and weight-related outcomes.[2]

The commonly reported expiration date for US 9,815,827 is June 5, 2026, subject to the controlling USPTO term calculation, any patent-term adjustment, and any terminal-disclaimer restrictions. A patent-term calculation should be confirmed against the USPTO Patent Center record and the current FDA Orange Book listing before use in a filing, launch or freedom-to-operate decision.[2,3]

The patent’s effective commercial life is separate from the basic lurasidone compound patent. Generic lurasidone entered the US market before the reported 2026 expiration through settlements or authorized-entry arrangements involving the relevant patent estate. An expiration date therefore does not by itself establish the actual generic launch date.

What is the Orange Book status of US 9,815,827?

US 9,815,827 has been associated with the FDA Orange Book patent listings for Latuda, a lurasidone hydrochloride product approved by the FDA. Its listing is a method-of-use listing rather than a listing for the lurasidone molecule itself.[3]

An Orange Book listing can require an ANDA applicant to make a certification under 21 U.S.C. § 355(j)(2)(A)(vii), including:

Paragraph I, if no relevant patent information is listed;
Paragraph II, if the patent has expired;
Paragraph III, if the applicant will wait until expiration;
Paragraph IV, if the applicant contends that the patent is invalid, unenforceable or will not be infringed.

A Paragraph IV notice can trigger a 45-day period for the patent holder to file suit. Timely litigation can produce a statutory 30-month stay of ANDA approval, subject to the Hatch-Waxman framework and court rulings concerning the listed patent and the applicant’s proposed use.

Which companies challenged the lurasidone patent estate?

Lurasidone faced extensive ANDA activity after the core product and formulation exclusivities approached expiration. Public litigation records identify challenges by multiple generic manufacturers, including major ANDA applicants and regional manufacturers. The relevant disputes involved several lurasidone patents, not only US 9,815,827.

The principal challenger categories included:

large Indian generic manufacturers;
US generic subsidiaries;
specialty generic companies;
vertically integrated manufacturers with lurasidone API capability.

The litigation record must be reviewed patent by patent. A settlement involving the lurasidone compound patent does not necessarily resolve US 9,815,827, and a settlement involving one ANDA applicant does not establish the rights of other applicants.

What litigation risks apply to the patent?

Infringement risk

A generic product presents the highest risk when its proposed label:

identifies schizophrenia or bipolar depression;
uses lurasidone hydrochloride;
includes 20, 40, 60, 80 or 120 mg strengths;
directs once-daily oral administration;
uses lurasidone as the only active ingredient;
describes a relatively low metabolic or weight-gain profile.

A “skinny label” could remove a patented indication or omit weight-related promotional language. That strategy may reduce induced-infringement risk, but it does not automatically eliminate liability if the remaining label, product design or physician conduct supports an infringement theory.

Validity risk

The most important validity challenges are likely to involve:

anticipation by earlier lurasidone clinical studies;
obviousness based on known lurasidone dosing and known metabolic tolerability;
lack of written description for the broad weight-outcome limitation;
enablement across the full 20 to 120 mg range and multiple indications;
indefiniteness of “clinically significant weight gain”;
obviousness-type double patenting in relation to related lurasidone patents.

The patentee’s strongest response would be that the claimed low-weight-gain outcome was clinically demonstrated at the claimed doses and that the prior art did not reasonably predict the result across the claimed patient populations.

Enforcement risk

The patent claims treatment outcomes rather than a distinctive chemical or manufacturing feature. That makes direct product testing less useful. Enforcement may depend on:

the generic label;
prescribing instructions;
promotional materials;
clinical trial protocols;
pharmacovigilance or risk-management documents;
evidence regarding the expected result of the proposed regimen.

A generic sponsor can also argue that a physician’s treatment decision and a patient’s actual weight outcome are separate from the manufacturer’s conduct.

Is there biosimilar risk?

No. Lurasidone is a small-molecule drug, not a biologic. The relevant competitors use the ANDA pathway for generic approval, not the biosimilar pathway under the Public Health Service Act.

The competitive threat is therefore conventional generic entry. Generic applicants may challenge listed patents, design a noninfringing label, obtain a settlement license, or enter after patent expiration. Manufacturing complexity is lower than for a biologic, although lurasidone stereochemistry, salt form, impurity control and formulation performance remain relevant technical issues.

How strong is the patent estate for lurasidone?

The lurasidone estate has multiple layers:

Estate layer	Function
Compound patents	Protect lurasidone chemical subject matter
Salt and solid-state patents	Protect hydrochloride, polymorph or solid forms where applicable
Formulation patents	Protect dosage-form or release characteristics
Method-of-use patents	Protect schizophrenia, bipolar and weight-related treatment protocols
Dose patents	Protect specific strengths or dosing schedules
Regulatory exclusivity	Delays or limits ANDA approval independently of patent rights

US 9,815,827 is best characterized as a method-of-use and dose/outcome patent. It is less robust against a generic that removes the relevant use from its label than a compound patent would be. It is more commercially relevant where the generic label tracks the full Latuda prescribing information.

What is the generic launch and revenue exposure?

Lurasidone generic entry began before the commonly reported June 2026 expiration date for US 9,815,827. The timing reflects settlement and authorized-entry arrangements across the broader lurasidone patent estate.

For the branded product, the major revenue exposure arose from the loss of US exclusivity for Latuda, which had been a significant commercial product for Sunovion and its parent, Sumitomo Pharma. Once multiple ANDA-approved products entered, price erosion and volume migration reduced the value of method-of-use patents as standalone commercial barriers.

The patent remains relevant to litigation and settlement economics, but it is unlikely to restore broad market exclusivity after authorized generic entry. Its principal value is defensive: preserving leverage over labels, entry dates and settlement terms.

Are there public licensing deals for US 9,815,827?

Public information supports Sunovion’s ownership and commercialization role for lurasidone in the United States. Publicly disclosed generic settlements may grant individual ANDA applicants defined entry rights, but those agreements are not necessarily public in full and should not be treated as broad licenses to all market participants.

No conclusion that a particular company has a license to US 9,815,827 should be drawn solely from a generic launch. The relevant settlement, consent judgment or license agreement must identify the patent and authorized entry date.

Key Takeaways

US 9,815,827 is a lurasidone treatment patent, not a compound patent.
Its core limitation is oral administration of 20 to 120 mg/day while avoiding clinically significant weight gain.
Claims cover schizophrenia, manic depressive psychosis, once-daily dosing, monotherapy, tablet compositions and commercial strengths from 20 mg through 120 mg.
The patent’s reported expiration is June 5, 2026, subject to USPTO term records and any applicable disclaimer or adjustment.
The phrase “clinically significant weight gain” is the central claim-construction and proof issue.
The patent is relevant to Orange Book and Paragraph IV analysis but does not alone determine the full lurasidone exclusivity period.
Lurasidone faces generic, not biosimilar, competition.
Generic entry before the reported patent expiration indicates that settlement or authorized-entry arrangements reduced the patent’s practical blocking power.

FAQs

Can a generic lurasidone product infringe US 9,815,827 without mentioning weight gain?

Yes. Infringement may be alleged if the proposed label and expected use satisfy the claim limitations even without an express weight-gain statement. The patentee would need to establish the applicable inducement or direct-infringement theory.

Does a 20 mg lurasidone tablet fall within the patent?

Yes. Multiple dependent claims expressly cover 20 mg once-daily administration and compositions containing 20 mg of lurasidone hydrochloride.

Does the patent cover lurasidone used with another antipsychotic?

Some independent claims may reach such treatment, but claims requiring no concurrent antipsychotic or sole active ingredient would not apply if another antipsychotic is administered.

Can a generic avoid the patent by using a capsule instead of a tablet?

Possibly for claims expressly requiring a tablet, but not necessarily for broader composition claims that do not include the tablet limitation. The remaining dose, route, indication and weight-outcome limitations would still matter.

Is “without weight gain” broader than “without clinically significant weight gain”?

Literally, “without weight gain” appears narrower as an outcome requirement because it requires no weight increase at all. It may be broader in practical dispute scope because the claim does not qualify the amount of weight change as clinically significant. Its enforceability depends on claim construction and the patent’s disclosure.

References

U.S. Food and Drug Administration. (2010). FDA approves Latuda for the treatment of schizophrenia. FDA Drug Safety and Approval Materials.
United States Patent and Trademark Office. (2017). U.S. Patent No. 9,815,827, Methods of treating schizophrenia. USPTO Patent Center and Patent Examination Data System.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. FDA Center for Drug Evaluation and Research.
U.S. Food and Drug Administration. (2024). Approved drug product label: Latuda (lurasidone hydrochloride) tablets. FDA Drugs@FDA.
Food, Drug, and Cosmetic Act, 21 U.S.C. § 355(j) (2024).

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	431147	⤷ Start Trial
Australia	2003257589	⤷ Start Trial
Germany	60327634	⤷ Start Trial
European Patent Office	1535616	⤷ Start Trial
European Patent Office	1944030	⤷ Start Trial
European Patent Office	2295061	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 9,815,827

Summary for Patent: 9,815,827