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
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
Columbia University	Phase 4
New York State Psychiatric Institute	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	8,883,794*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	AB	RX	Yes	No	9,259,423*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No	8,729,085*PED				Y
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	AB	RX	Yes	No	9,827,242
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-003	Dec 7, 2011	AB	RX	Yes	No	9,827,242
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	AB	RX	Yes	No	8,883,794*PED				Y

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	200603-003	Dec 7, 2011	9,815,827
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-005	Jul 12, 2013	9,815,827
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010	9,815,827
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-002	Oct 28, 2010	9,815,827
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-004	Apr 26, 2012	9,815,827

International Patents for LATUDA

When does loss-of-exclusivity occur for LATUDA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	I359020
Greece	3026697
Spain	2326078
Spain	2378990
World Intellectual Property Organization (WIPO)	2006126681
Japan	5855670

Supplementary Protection Certificates for LATUDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1884242	251 5024-2014	Slovakia		PRODUCT NAME: LURASIDON; REGISTRATION NO/DATE: EU/14/913/001 - EU/14/913/021 20140327
1884242	CR 2014 00049	Denmark		PRODUCT NAME: LURASIDON HYDROCHLORID; REG. NO/DATE: EU/1/14/913/001-021 20140327
1884242	132014902294693	Italy		PRODUCT NAME: LURASIDONE, OPZIONALMENTE IN FORMA DI BASE LIBERA O DI SUOI SALI FARMACEUTICAMENTE ACCETTABILI(LATUDA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/913, 20140321
1884242	C 2014 038	Romania		PRODUCT NAME: LURASIDONA, OPTIONAL SUB FORMA BAZEI EI LIBERE SAU CA SARURIACCEPTABILE FARMACEUTIC ALREA (EEA): EU/1/14/913; DATE OF FIRST AUTHORISATION IN EEA: 20140321 E ACESTEIA, IN SPECIAL CLORHIDRAT DE LURASIDONA -C28H36N4O2S; NATIONAL AUTHORISATION NUMBER: EU/1/14/913; DATE OF NATIONAL AUTHORISATION: 20140321; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC A
1884242	C20140030 00118	Estonia		PRODUCT NAME: LURASIDOON;REG NO/DATE: K(2014)2046 (LOPLIK) 27.03.2014
1884242	SPC/GB14/063	United Kingdom		PRODUCT NAME: LURASIDONE HYDROCHLORIDE; REGISTERED: UK EU/1/14/913/001 20140327; UK EU/1/14/913/002 20140327; UK EU/1/14/913/003 20140327; UK EU/1/14/913/004 20140327; UK EU/1/14/913/005 20140327; UK EU/1/14/913/006 20140327; UK EU/1/14/913/007 20140327; UK EU/1/14/913/008 20140327; UK EU/1/14/913/009 20140327; UK EU/1/14/913/010 20140327; UK EU/1/14/913/011 20140327; UK EU/1/14/913/012 20140327; UK EU/1/14/913/013 20140327; UK EU/1/14/913/014 20140327; UK EU/1/14/913/015 20140327; UK EU/1/14/913/016 20140327; UK EU/1/14/913/017 20140327; UK EU/1/14/913/018 20140327; UK EU/1/14/913/019 20140327; UK EU/1/14/913/020 20140327; UK EU/1/14/913/021 20140327

Latuda (lurasidone): Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

What is Latuda’s market position across major geographies and channels?

Latuda (lurasidone) operates in a branded, mid-to-high priced, mono-therapeutic market segment within psychiatry, competing primarily against other branded atypical antipsychotics and branded long-acting injectables used for schizophrenia and bipolar-spectrum indications.

Core commercial footprint

• Indications (commercial base):
  • Schizophrenia (adult; and in practice includes studied adolescent populations)
  • Bipolar depression (bipolar I, depressive episodes)
• Competitive set (commercial substitute classes):
  • Oral atypical antipsychotics used for schizophrenia and bipolar disorders (e.g., aripiprazole products, olanzapine-based regimens)
  • Other bipolar-depression agents (including antidepressant-class and atypical antipsychotic competitors used for depressive episodes)
  • Long-acting injectables for schizophrenia adherence and relapse prevention (class competition for persistence and payer preference)

Channel structure

• US commercial model: largely managed care driven, with payer step edits and prior authorization risk controls that typically concentrate uptake in formularies with preferred tiers.
• International model: branded penetration is more sensitive to national reimbursement rules and generic entry timing by market.

How have key pricing and reimbursement forces shaped revenue outcomes?

Latuda’s financial trajectory has been driven by a combination of (1) branded pricing and (2) payer restrictiveness around schizophrenia and bipolar depression dosing. The net effect is that sales growth or stabilization has depended less on headline list price and more on formulary access and adherence.

Primary demand drivers

• Formulary placement and prior authorization outcomes
  • Commercial uptake is tightly linked to whether plans cover lurasidone without excessive utilization management.
• Dose optimization and tolerability
  • In payer-covered populations, uptake tracks real-world adherence and discontinuation patterns, which are influenced by adverse-event incidence and symptom control.
• Switching dynamics
  • Patients and prescribers switch within antipsychotic classes based on efficacy-per-side-effect profiles and convenience (oral vs injectable; once-daily options where applicable).

Primary headwinds

• Branded-to-generic pressure risk
  • Latuda’s branded economics weaken as generics or authorized generics enter major markets, compressing net pricing and forcing volume migration.
• Bipolar depression is a contested niche
  • Payers treat bipolar depression as a budget-sensitive segment, often requiring step therapy among covered alternatives.

What are the financial trajectory markers from disclosed results?

Latuda’s financial performance is reported historically via drug-level net sales disclosures by the manufacturer in periodic filings. For business planning, the most decision-relevant markers are:

• Net sales trend direction (growth vs contraction)
• Country and segment mix shifts
• Any changes in gross-to-net driven by rebates, discounts, and payer mix

Drug-level topline trend

• Latuda is carried in investor reporting as a branded psychiatric asset; its sales performance has historically shown:
  • Initial growth phase driven by schizophrenia adoption and subsequent bipolar-depression expansion
  • Later stabilization and then contraction risk when payer restrictiveness increased and competition intensified
  • Ongoing headwinds from generic competition risk as market exclusivity ended or eroded, depending on geography and timeline

Ongoing effect of exclusivity and patent stack

Latuda’s ability to hold premium pricing depends on its remaining regulatory and patent exclusivity in each market. When exclusivity erodes, net price typically falls faster than volume rebounds, resulting in net sales decline even if prescriptions persist at some level.

How do patent and litigation dynamics impact expected revenue life?

Latuda’s patent position and exclusivity posture govern the timetable for generic entry. These dynamics directly affect:

• Expected peak sales and post-peak erosion speed
• Time-to-generic substitution at formulary level
• Potential for authorized generics or settlement-driven launch timing

Why this matters for valuation and R&D

• Expected revenue life compresses when patent protection weakens.
• Switching of payer contracts accelerates generic uptake.
• Manufacturer incentive to defend indication breadth declines as exclusivity narrows.

What competitive moves determine Latuda’s share trajectory?

Latuda’s share outcome is largely a function of competitive portfolio breadth in psychiatry and managed care coverage design.

Competitive coverage mechanics

• Plans often design formularies around:
  • Preferred tier access for a limited subset of atypicals
  • Step edits for bipolar depression
  • Limits tied to age and diagnosis confirmation
• In practice, Latuda’s performance depends on whether it lands in preferred access categories versus “restricted” categories requiring prior authorization.

Substitution risk

• Generic atypicals reduce the premium value of brands.
• If a competing brand achieves better payer access, prescribers shift, especially for bipolar depression where symptom control and tolerability profiles guide selection.

What is the most important market dynamic for Latuda’s financial trajectory: formulation or indication growth?

Latuda’s commercial trajectory has been shaped more by indication uptake and payer coverage than by meaningful formulation step-changes. The bipolar depression segment and schizophrenia segment have different payer dynamics:

• Schizophrenia has sustained demand but is more sensitive to long-acting competitors and generic substitution.
• Bipolar depression is smaller but more strategically targeted by payers and competitor programs.

How does the business impact of generic entry translate into revenue erosion?

Generic competition tends to produce:

• Rapid loss of net pricing (rebates and discounts intensify to defend contracts)
• Lower paid share as prescribers switch to low-cost options
• Possible “residual share” persistence in patients with established tolerability, but not enough to offset pricing loss

Erosion pattern businesses typically model

• Pre-launch: managed care tightens criteria for brand, increasing friction.
• Launch year: net sales often decline steeply as formularies switch.
• Post-launch: volume stabilizes at a reduced base while pricing falls further, driving continued decline.

What does the pathway of lurasidone development suggest about long-run commercial sustainability?

The long-run sustainability for Latuda depends on whether the company can:

• Defend key indications through evidence generation and payer negotiations
• Extend market exclusivity with patent filings and life-cycle strategies
• Maintain tolerability-driven persistence despite competitive substitutes

Key Takeaways

• Latuda’s market dynamics are governed by managed care access for schizophrenia and bipolar depression, with prior authorization and tier placement determining paid share.
• Financial trajectory has followed the typical branded psychiatry pattern: growth during access expansion, then stabilization under competitive pressure, followed by downside risk tied to exclusivity erosion and generic substitution.
• Patent and exclusivity timing in each geography is the key determinant of revenue life and the speed of net sales compression.
• Competitive response is channel-driven: preferred formulary access and step-therapy design determine whether Latuda sustains prescriptions or loses share to lower-cost alternatives.
• Generic entry modeling is central to business planning because net pricing typically falls faster than volume can stabilize.

FAQs

1) What indications drive Latuda’s commercial performance?

Latuda is driven primarily by schizophrenia and bipolar depression (bipolar I depressive episodes), with commercial uptake dependent on payer coverage and utilization management.

2) What type of competition most affects Latuda?

Competition comes from oral atypical antipsychotics and long-acting injectables in schizophrenia, plus branded and generic alternatives used for bipolar depression.

3) How do payers influence Latuda’s revenue trajectory?

Payers influence paid share through formulary tier placement, prior authorization, and step edits, which affect how quickly prescribers can initiate therapy.

4) What is the dominant financial risk for Latuda?

The dominant risk is exclusivity erosion leading to generic substitution, which compresses net pricing and accelerates net sales decline.

5) What sustains Latuda after competitive pressure?

Residual share persistence can occur when patients tolerate lurasidone well and remain on therapy, but this typically cannot fully offset pricing loss after generic entry.

References

[1] AbbVie Inc. and its affiliates. SEC filings (Form 10-K, Form 10-Q) and investor disclosures for pharmaceutical net sales by product.
[2] U.S. Food and Drug Administration. Drug approvals and labeling information for Latuda (lurasidone).
[3] GlobalData / EvaluatePharma style market reporting compendia. Branded psychiatry market dynamics and competitor landscapes for antipsychotic and bipolar-depression products.