LURASIDONE HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for lurasidone hydrochloride and what is the scope of freedom to operate?

Lurasidone hydrochloride is the generic ingredient in two branded drugs marketed by Sunovion Pharms Inc, Accord Hlthcare, Alembic, Alkem Labs Ltd, Amneal Pharms Co, Annora Pharma, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Heritage Pharma Avet, Invagen Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, MSN, Sun Pharm, Teva Pharms Usa, Torrent, Watson Labs Teva, and Zydus Pharms, and is included in twenty NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lurasidone hydrochloride has forty-four patent family members in twenty-two countries.

There are twenty-six drug master file entries for lurasidone hydrochloride. Twenty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LURASIDONE HYDROCHLORIDE

International Patents:	44
US Patents:	6
Tradenames:	2
Applicants:	20
NDAs:	20
Drug Master File Entries:	26
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	56
Clinical Trials:	81
Patent Applications:	311
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LURASIDONE HYDROCHLORIDE
What excipients (inactive ingredients) are in LURASIDONE HYDROCHLORIDE?	LURASIDONE HYDROCHLORIDE excipients list
DailyMed Link:	LURASIDONE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for LURASIDONE HYDROCHLORIDE

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

Sponsor	Phase
University Health Network, Toronto	PHASE1
Centre for Addiction and Mental Health	PHASE1
Patient-Centered Outcomes Research Institute	PHASE4

See all LURASIDONE HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for LURASIDONE HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
		60MG	TABLET;ORAL
		40MG	TABLET;ORAL
		20MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LURASIDONE HYDROCHLORIDE

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for LURASIDONE HYDROCHLORIDE

Adrenergic alpha-2 Receptor Antagonists

Antipsychotic Agents

Dopamine D2 Receptor Antagonists

Serotonin 5-HT2 Receptor Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for LURASIDONE HYDROCHLORIDE

N05AE	Indole derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for LURASIDONE HYDROCHLORIDE

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 LURASIDONE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	213248-004	May 13, 2021	AB	RX	No	No
Aurobindo Pharma Ltd	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208045-005	Mar 10, 2023	AB	RX	No	No
Sunovion Pharms Inc	LATUDA	lurasidone hydrochloride	TABLET;ORAL	200603-001	Oct 28, 2010	AB	RX	Yes	Yes	8,729,085*PED				Y
Msn	LURASIDONE HYDROCHLORIDE	lurasidone hydrochloride	TABLET;ORAL	208037-002	Sep 9, 2022	AB	RX	No	No

Expired US Patents for LURASIDONE HYDROCHLORIDE

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

International Patents for LURASIDONE HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Poland	1884242
World Intellectual Property Organization (WIPO)	2012063513
European Patent Office	1884242	COMPOSITION PHARMACEUTIQUE COMPRENANT LE LURASIDONE (PHARMACEUTICAL COMPOSITION COMPRISING LURASIDONE)
Luxembourg	92550

Supplementary Protection Certificates for LURASIDONE HYDROCHLORIDE

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

Lurasidone Hydrochloride: Market Dynamics and Financial Trajectory

Last updated: April 23, 2026

What is lurasidone hydrochloride’s market position in psychiatry?

Lurasidone (marketed in the US as Latuda by Sunovion) is an atypical antipsychotic with a differentiated label focus on schizophrenia and bipolar depression. Its commercial trajectory is driven by (1) US brand lifecycle management, (2) payer coverage and step-therapy controls in schizophrenia and bipolar depression, and (3) competitive pressure from other SGAs plus long-acting injectables where clinically appropriate.

From a demand standpoint, lurasidone’s opportunity has remained anchored to patients treated for schizophrenia and for bipolar depression. From a supply standpoint, its market has continued to face incremental generic pressure as regulatory exclusivities unwind, with biosimilar-like substitution economics not applying (it is a small molecule).

How has demand evolved across key indications?

Across major markets, lurasidone demand is shaped by two pools:

• Schizophrenia (core base): steady maintenance demand with refill cadence and controlled physician switching because clinical response and tolerability are central.
• Bipolar depression (higher payer scrutiny): more utilization management (prior authorization, diagnosis confirmation, and formulary tiering) than schizophrenia, with revenue sensitivity to payer policy shifts.

While the exact indication mix varies by geography and payer, the financial outcome is typically a function of:

• formulary access (preferred vs non-preferred tier),
• prior authorization and step-edit burden,
• and relative net pricing after rebates.

What market dynamics have most affected unit economics and net sales?

Net sales trajectories for lurasidone generally reflect the interaction of three forces:

1) Formulary access and rebate pressure

After early adoption, SGAs face growing rebate and contracting pressure. Lurasidone’s pricing power depends on plan tiering and the ability to defend it clinically. As formularies refresh, utilization shifts toward preferred SGAs and, in some segments, toward LAIs.

2) Competitive intensity within atypical antipsychotics

Lurasidone competes against a broad set of SGAs and related products used for schizophrenia and bipolar mood disorders. Competition impacts:

• share-of-therapy,
• average selling price (net of rebates),
• and willingness-to-switch among payers and prescribers when efficacy is judged similar and side-effect profiles overlap.

3) Convenience and adherence dynamics

Oral antipsychotics face adherence variability; where LAIs are covered and aligned to patient needs, they can reduce share for oral products. This effect tends to intensify in maintenance populations.

How has the financial trajectory looked through major lifecycle phases?

Lurasidone has followed a common branded antipsychotic lifecycle pattern:

Phase A: Growth and label expansion (brand ramp)

• Early commercial gains were driven by US brand uptake and payer adoption.
• Bipolar depression uptake tends to lag schizophrenia because diagnosis workflows require additional documentation and payers apply stronger controls.

Phase B: Maturation (stable revenue with payer tightening)

• As the market matured, revenue became more sensitive to rebate rate changes and formulary status.
• Contracting and utilization management drove volatility even when underlying patient counts held up.

Phase C: Late brand lifecycle (generic and policy pressure)

• Once generic risk increased globally, net pricing typically compressed as wholesalers, payers, and some prescribers anticipated supply and price shifts.
• Competitive action and payer contract redesign then become dominant drivers of revenue.

What role do exclusivity and generic entry risks play in the trajectory?

Lurasidone’s risk profile is determined by:

• Patent term and exclusivity cliffs
• Regulatory approvals and potential ANDA launches
• Manufacturing capacity and market readiness

Generic competition for small molecules typically compresses price quickly after launch. The financial trajectory around the cliff is usually characterized by:

• accelerated net price erosion,
• loss of formulary preference,
• and volume declines where substitution is permitted.

What has the supply and regulatory environment implied for forecasting?

For small-molecule generics, forecasting depends on whether ANDA approvals translate into actual market launches and how payers react. Key indicators that usually precede financial impact include:

• ANDA milestones and approvals,
• patent litigation outcomes affecting “launch at risk,”
• and payer step-edit changes triggered by anticipated competition.

What are the actionable financial drivers for investors and commercial planners?

The lurasidone financial outlook can be operationalized into four controllable and trackable drivers:

1. Net price (after rebates)
   • Trend is the primary proxy for competitive contracting pressure.
2. Formulary tiering
   • Preferred tier retention protects volume; downgrade signals margin contraction and volume loss.
3. Prior authorization burden
   • Increased utilization management reduces eligible uptake, especially in bipolar depression.
4. Switching environment
   • Evaluate therapeutic alternatives favored by payer panels and health plans, including LAI substitution patterns.

How does the market compare versus major SGA peers on commercialization dynamics?

While exact performance by brand requires company-level reporting, the structural pattern is consistent across SGAs:

• Schizophrenia: more stable demand but increasingly rebate-driven.
• Bipolar depression: more payer-managed; label differentiation matters but net revenue is more sensitive to policy changes.
• Maintenance populations: oral brands face share erosion where LAIs gain coverage and clinical momentum.

Lurasidone’s commercial “shape” tends to mirror that of brands with meaningful differentiation but subject to steady competitive substitution over time.

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Key datapoints and timeline anchors

The following anchors frame the commercialization lifecycle and the patent and regulatory environment that govern the financial trajectory. (These anchors are used as reference points for investment-grade timing analysis.)

Category	What to monitor	Why it matters for financial trajectory
US brand lifecycle	Patent term and exclusivity end dates; litigation outcomes	Determines whether and when generic pricing pressure begins
ANDA activity	Approval/launch indications; “at risk” behavior	Impacts the speed and magnitude of net sales erosion
US payer behavior	Step edit and prior authorization changes by major PBMs	Determines share-of-therapy and eligible patient capture
Indication mix	Relative share of schizophrenia vs bipolar depression	Bipolar depression is typically more utilization managed

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Key Takeaways

• Lurasidone’s revenue trajectory is governed by payer access, rebate intensity, and competitive substitution within schizophrenia and bipolar depression.
• The bipolar depression indication is structurally more exposed to prior authorization and step-edit tightening, making net sales more policy-sensitive than schizophrenia.
• Financial compression risk increases when generic launch probability rises, typically producing rapid net price and volume deterioration for small-molecule oral brands.
• For forecasting and investment decisions, the most decision-relevant signals are net price trend, formulary tier status, ANDA launch timing, and payer policy changes rather than raw prescriptions alone.

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FAQs

1. Which indication most drives payer scrutiny for lurasidone?
   Bipolar depression, because diagnosis confirmation and utilization management requirements tend to be stricter than for schizophrenia.

2. What is the main lever behind net sales performance for lurasidone?
   Net price after rebates, closely tied to formulary tiering and contract terms.

3. How does generic entry typically affect lurasidone revenue?
   For oral small molecules, generic launch usually triggers a fast compression in net pricing and formulary preference, followed by volume erosion.

4. What competition dynamics matter most for lurasidone?
   Competitive SGA contracting and, in maintenance settings, substitution toward long-acting injectables where coverage supports it.

5. What timing signals best indicate an inflection point for the financial trajectory?
   ANDA approval and launch activity, patent litigation milestones, and payer prior authorization policy changes that occur ahead of or alongside expected generic availability.

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References

[1] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] FDA. Drug Approval Reports and Drug Labels (LURASIDONE HYDROCHLORIDE product labeling). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] Sunovion. Latuda (lurasidone) US prescribing information. https://www.latuda.com/