LATUDA Drug Patent Profile

When do Latuda patents expire, and when can generic versions of Latuda launch?

Latuda is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in twenty-two countries.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the lurasidone hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Latuda

A generic version of LATUDA was approved as lurasidone hydrochloride by ACCORD HLTHCARE on January 3^rd, 2019.

Summary for LATUDA

International Patents:	44
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	104
Clinical Trials:	24
Patent Applications:	218
Drug Prices:	Drug price information for LATUDA
Drug Sales Revenues:	Drug sales revenues for LATUDA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LATUDA
What excipients (inactive ingredients) are in LATUDA?	LATUDA excipients list
DailyMed Link:	LATUDA at DailyMed

See drug prices for LATUDA

See drug sales revenues for LATUDA

Recent Clinical Trials for LATUDA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
New York State Psychiatric Institute	Phase 4
Columbia University	Phase 4
Astellas Pharma Global Development, Inc.	Phase 2

See all LATUDA clinical trials

Pharmacology for LATUDA

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for LATUDA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LATUDA	Tablets	lurasidone hydrochloride	20 mg, 40 mg, 60 mg, 80 mg, and 120 mg	200603	14	2014-10-28

US Patents and Regulatory Information for LATUDA

LATUDA is protected by seven US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No					Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	AB	RX	Yes	No					Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No					Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No

Expired US Patents for LATUDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-003	Dec 7, 2011

International Patents for LATUDA

See the table below for patents covering LATUDA around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	165359
Brazil	1100153
Canada	2046429	DERIVES D'IMIDE; PREPARATION ET UTILISATION (IMIDE DERIVATIVES, AND THEIR PRODUCTION AND USE)
Germany	69129282

Supplementary Protection Certificates for LATUDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1884242	92550	Luxembourg		PRODUCT NAME: LURASIDONE, FACULTATIVEMENT SOUS FORME DE SA BASE LIBRE OU DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES. FIRST REGISTRATION: 20140327
1884242	C300690	Netherlands		PRODUCT NAME: LURASIDON, OPTIONEEL IN DE VORM VAN ZIJN VRIJE BASE OF FARMACEUTISCH ACCEPTABELE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/14/913 20140321
1884242	CA 2014 00049	Denmark		PRODUCT NAME: LURASIDON, EVENTUELT I FORM AF DEN FRIE BASE ELLER FARMACEUTISK ACCEPTABLE SALTE DERAF, HERUNDER LURASIDONHYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140321
1884242	PA2014034	Lithuania		PRODUCT NAME: LURASIDONUM; REGISTRATION NO/DATE: EU/1/14/913 20140321

LATUDA (lurasidone) Market Dynamics and Financial Trajectory: Revenue Drivers, Exclusivity Timeline, Competitive Pressure, and Patent-to-Generic Transition Risk

Last updated: June 17, 2026

What is LATUDA’s current market footprint and who competes in schizophrenia and bipolar disorder?

LATUDA (lurasidone) is marketed for schizophrenia and bipolar depression (bipolar I disorder). Demand is driven by managed-care adoption, formulary positioning, and persistence, with competitive pressure concentrated in second-generation antipsychotics (SGAs) and bipolar-depression agents.

Demand drivers that move monthly prescriptions

• Formulary status in commercial plans and state Medicaid preferred drug lists
• Prior authorization outcomes and step-therapy patterns
• Patient tolerability and clinician adherence (metabolic and sedation profiles versus alternatives)
• Uptake channel: specialty pharmacy and wholesaler ordering cadence
• Generic substitution readiness once exclusivity ends

Competitive set (principal SGA and bipolar-depression alternatives)

Key alternatives for prescribers include:

• Other SGAs for schizophrenia: aripiprazole (including long-acting injectables), brexpiprazole, olanzapine, risperidone, quetiapine, ziprasidone
• Bipolar depression competitors: quetiapine, lurasidone competitors by class and payor placement (notably SGAs with bipolar indications)
• Adjacent mechanistic competitors: antidepressant or adjunct strategies for bipolar depression in combination patterns where permitted

How has LATUDA’s revenue trended, and what are the financial inflection points?

LATUDA’s financial trajectory has been shaped by (1) post-2016 growth to establish a bipolar-depression base, (2) incremental saturation as SGAs consolidated share, and (3) later-stage erosion risk tied to exclusivity and generic entry timing.

Revenue inflection structure

• Early scaling: bipolar depression indication expansion supported prescription lift as clinicians built switching and add-on habits.
• Mid-cycle maturity: as formularies tightened and step edits increased, growth shifted from net-new share to continuity and line-extension dynamics.
• Late-cycle headwinds: competitive intensity rose as other SGAs maintained preferred positioning and payors shifted to cost-controlled options.

Commercial exposure areas that typically decide profit

• Net price: discounts and rebate pressure as generic and lower-cost alternatives loom
• Mix shift: dose and formulation mix in response to tolerability and prescriber preference
• Service economics: patient support programs and specialty distribution costs
• Manufacturing and supply continuity: volume stability reduces fixed-cost drag

When does LATUDA lose exclusivity in the US, and what generic entry risks exist?

LATUDA’s US exclusivity profile depends on the Orange Book patent set and any non-patent exclusivities tied to the NDA (including potential data exclusivity and pediatric exclusivity). In practice, the generic timeline is determined by the last-expiring patent that is listed in the Orange Book and successfully blocks ANDA entry unless a Paragraph IV challenge clears the statutory stay landscape.

What patents control generic timing for LATUDA?

Generic entry risk is driven by:

• The expiration dates of composition-of-matter patents covering lurasidone
• The expiration dates of formulation and method-of-use patents, if they remain listed and are asserted or not waived
• Any exclusivity protections that add a “hard stop” beyond patent expiry

Paragraph IV challenge impact

If an ANDA filer files a Paragraph IV certification against one or more Orange Book-listed patents, the FDA approval and market launch are governed by:

• The 30-month litigation stay triggered by a timely lawsuit
• Settlement agreements that can shift the “at-risk” launch window
• Court rulings that narrow or invalidate specific claims

Biosimilar risk?

LATUDA is a small molecule (not biologic), so biosimilar risk is not applicable.

What does the Orange Book status of LATUDA show for patent coverage?

LATUDA is governed by Orange Book-listed NDA and patent families that typically include:

• Active ingredient (lurasidone) composition claims
• Salt form or polymorph-related claims if applicable to the marketed product
• Formulation claims tied to specific dose strengths, release characteristics, or manufacturing parameters
• Method-of-use claims linked to approved indications and dosing regimens

How to interpret the patent estate for generic blocking

For timing and litigation:

• Identify the “last relevant date” concept: the latest date that blocks ANDA marketing for each listed NDA
• Track which patents are asserted in litigation (if any) to determine practical blocking power
• Separate device-like manufacturing/process patents (if listed) from product claims that are more routinely challenged

Which LATUDA formulations and doses are protected, and how does that shape launch timing?

LATUDA’s market is built on multiple dose strengths used in schizophrenia and bipolar depression. Formulation and method-of-use coverage often varies by strength, and some exclusivity gaps can emerge when:

• Only specific dose strengths have distinct formulation patents
• Process improvements are patented separately from composition claims
• Method-of-use coverage is narrower than composition, allowing “carve-outs” if a generic can design around

Typical protected product claim types (what matters for launch)

• Composition-of-matter
• Formulation for oral administration
• Method-of-use for approved regimens
• Manufacturing process constraints that may affect feasibility or trigger infringement risk

What patent litigation and settlements could affect LATUDA generic launches?

LATUDA’s generic threat is a function of litigation and settlement outcomes. Where Paragraph IV challenges occur:

• The filing-to-stay period is often the earliest measurable timing inflection
• Settlements can cap generic launch dates below theoretical patent expiry
• Court rulings can either accelerate generic availability or narrow claim scope enough to enable design-around work

Litigation-driven launch scenarios

• Settlement allowing launch before full patent expiry (date-specific)
• Court invalidation or non-infringement of key claims (accelerated date)
• Partial settlements tied to specific patents, leaving other patents to control final exclusivity

How does LATUDA’s competitive landscape compare with quetiapine and other SGAs for bipolar depression?

For bipolar depression, clinical choices tend to track:

• Efficacy and patient response patterns
• Side-effect tolerability, especially weight gain and sedation burden
• Real-world adherence and discontinuation due to adverse events

Share dynamics in bipolar depression

When payors select preferred SGAs, LATUDA share typically depends on:

• Placement on formulary tiers
• Step edit requirements (trial of preferred agent before coverage)
• Prior authorization criteria (documentation of prior treatment, diagnosis confirmation)
• Copay assistance impact, including specialty pharmacy switching friction

What are the payor and distribution mechanics that drive LATUDA market performance?

LATUDA performance is highly sensitive to rebate and net pricing mechanics.

Managed care and specialty pharmacy dynamics

• Higher rebate intensity often correlates with preferred placement but compresses net margin
• Specialty distribution improves persistence but costs more than non-specialty pathways
• Prior authorization requirements reduce volume but can increase margins via controlled use

Wholesaler and channel inventory effects

• Ordering spikes around formulary events can create quarter-to-quarter revenue volatility
• Inventory digestion following generic entry risk can distort near-term reported sales

How strong is the LATUDA patent estate, and where are the weakening points?

Patent estate strength is a function of:

• Number of Orange Book-listed patents per NDA and per claim category
• Remaining time to expiry for the latest-expiring family
• Litigation posture and claim scope breadth
• Complexity that increases generic design-around costs

Weakening points investors and counsel monitor

• Narrow method-of-use claims that are easier to avoid
• Formulation patents that do not cover the final commercialized generic product design
• Settlement-driven earlier entry that effectively shifts the practical end of exclusivity

What generic entry scenarios could happen for LATUDA, and what is the revenue impact pathway?

Generic entry typically causes:

• Immediate pricing pressure upon launch
• Rapid share shift if the generic is placed as preferred and payer coverage is optimized
• Continued erosion if additional ANDA applicants launch or if multiple dosage strengths become available

At-risk revenue pathways

• Pre-entry: anticipation of launch can slow new patient starts depending on contracting and clinician behavior
• Launch quarter: net sales decline driven by conversion and rebate changes
• Post-launch: further declines if competing generics enter and if PBMs renegotiate tiers

Key product and financial KPIs to track for LATUDA

To model financial trajectory through the exclusivity window, track:

• Prescription volume (monthly Rx) and script mix by dose strength
• Net price, discount rate, and rebate intensity from payer contracting
• Specialty distribution share and inventory adjustments
• Formulary tier movement and prior authorization rule changes
• Generic launch watchlist based on ANDA Paragraph IV activity tied to Orange Book patents

Key Takeaways

• LATUDA’s market dynamics are controlled by managed-care formulary positioning, prior authorization behavior, and tolerability-based persistence in schizophrenia and bipolar depression.
• Financial trajectory is driven by maturity and net-price compression risk as lower-cost SGAs and future generics intensify cost pressure.
• Generic entry risk is determined by the latest-expiring Orange Book-listed patents and the Paragraph IV litigation or settlement path that governs practical launch timing.
• Formulation and method-of-use patent coverage can create strength pockets that affect whether generics can launch across all dose strengths simultaneously.

FAQs

1) What event most reliably predicts a LATUDA revenue downturn in the US market?
A change in formulary status that triggers stronger prior authorization or tier downgrades, often coupled with credible generic launch indicators tied to Orange Book patent challenges.

2) How do Paragraph IV filings usually shift the timeline for LATUDA generic competition?
They typically trigger an FDA approval-and-launch stay based on litigation timing, with settlement outcomes often moving the practical launch date.

3) Do dose strengths of LATUDA face different generic blocking risk?
Yes, because formulation and product-specific patents may vary by strength and covered composition or manufacturing parameters.

4) Does LATUDA face biosimilar-type competition?
No, LATUDA is a small molecule and does not have biosimilar competition.

5) Which commercial levers matter most to protect LATUDA net sales near exclusivity end?
Managed-care contracting strategy, rebate-to-tier alignment, prior authorization performance, and rapid conversion resistance via patient support and adherence programs.

References

1. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (n.d.). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
2. FDA. (n.d.). Patent and Exclusivity Information for Drugs. U.S. Food and Drug Administration. https://www.fda.gov/drugs/competition-generics/patent-and-exclusivity-information-drugs

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