SYMBYAX Drug Patent Profile

Which patents cover Symbyax, and when can generic versions of Symbyax launch?

Symbyax is a drug marketed by Lilly and is included in one NDA.

The generic ingredient in SYMBYAX is fluoxetine hydrochloride; olanzapine. There are twenty-seven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the fluoxetine hydrochloride; olanzapine profile page.

Summary for SYMBYAX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	5
Drug Prices:	Drug price information for SYMBYAX
What excipients (inactive ingredients) are in SYMBYAX?	SYMBYAX excipients list
DailyMed Link:	SYMBYAX at DailyMed

See drug prices for SYMBYAX

Recent Clinical Trials for SYMBYAX

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

Sponsor	Phase
Eli Lilly and Company	Phase 3
Eli Lilly and Company	Phase 4
M.D. Anderson Cancer Center	Phase 1

See all SYMBYAX clinical trials

Pharmacology for SYMBYAX

Drug Class	Atypical Antipsychotic Serotonin Reuptake Inhibitor
Mechanism of Action	Serotonin Uptake Inhibitors

Paragraph IV (Patent) Challenges for SYMBYAX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SYMBYAX	Capsules	fluoxetine hydrochloride; olanzapine	6 mg/25 mg 12 mg/25 mg 6 mg/50 mg 12 mg/50 mg	021520	1	2005-01-10

US Patents and Regulatory Information for SYMBYAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-001	Apr 9, 2007		DISCN	Yes	No
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-003	Dec 24, 2003		DISCN	Yes	No
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-002	Dec 24, 2003		DISCN	Yes	No
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-004	Dec 24, 2003		DISCN	Yes	No
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-005	Dec 24, 2003		DISCN	Yes	No

Expired US Patents for SYMBYAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-004	Dec 24, 2003
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-005	Dec 24, 2003
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-003	Dec 24, 2003
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-001	Apr 9, 2007
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-004	Dec 24, 2003
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-005	Dec 24, 2003
Lilly	SYMBYAX	fluoxetine hydrochloride; olanzapine	CAPSULE;ORAL	021520-004	Dec 24, 2003

International Patents for SYMBYAX

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

Country	Patent Number	Title	Estimated Expiration
Brazil	9708254
Finland	971316
Mexico	25502	PROCEDIMIENTO PARA LA PRODUCCION DE 2-METIL-10-(4-METIL-1-PIPERAZINIL)-4H-TIENO(2,3-b)(1,5)BENZODIAZEPINA Y PRODUCTO OBTENIDO.
Hungary	0101901
Portugal	97446	PROCESSO PARA A PREPARACAO DE UM DERIVADO DE TIENOBENZODIAZEPINA, UTIL COMO PRODUTO FARMACEUTICO
Israel	112575	4-Substituted 2-methyl-10h-thieno [2,3-b][1,5]benzodiazepine
Australia	643267

Supplementary Protection Certificates for SYMBYAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0454436	C970015	Netherlands		PRODUCT NAME: OLANZAPINE, DESGEWENST IN DE VORM VAN EEN ZUURADDITIEZOUT; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927
0454436	SPC/GB96/058	United Kingdom		PRODUCT NAME: OLANZAPINE OPTIONALLY IN THE FORM OF AN ACID ADDITION SALT; REGISTERED: UK EU/1/96/022/001 19960927; UK EU/1/96/022/002 19960927; UK EU/1/96/022/003 19960927; UK EU/1/96/022/004 19960927; UK EU/1/96/022/005 19960927; UK EU/1/96/022/006 19960927; UK EU/1/96/022/007 19960927; UK EU/1/96/022/008 19960927; UK EU/1/96/022/009 19960927; UK EU/1/96/022/010 19960927
0454436	CA 2001 00042	Denmark
0454436	97C0012	Belgium		PRODUCT NAME: OLANZAPINE; REGISTRATION NO/DATE: EU/1/96/022/001 19960927
0454436	9/1997	Austria		PRODUCT NAME: OLANZAPIN ODER EIN SAEUREADDITIONSSALZ HIEVON; REGISTRATION NO/DATE: EU/1/96/022/001 - EU/1/96/022/010 19960927

Market Dynamics and Financial Trajectory for SYMBYAX

Last updated: July 29, 2025

Introduction

SYMBYAX, a combination pharmacotherapy approved by the U.S. Food and Drug Administration (FDA), integrates olanzapine, an atypical antipsychotic, with fluoxetine, a selective serotonin reuptake inhibitor (SSRI). Marketed primarily for treatment-resistant depression (TRD) and bipolar disorder, SYMBYAX’s commercial outlook hinges on evolving clinical guidelines, competitive landscape, regulatory decisions, and prescribing behaviors. This report dissects the key drivers shaping SYMBYAX’s market dynamics and projects its financial trajectory through a detailed analysis.

Market Context for SYMBYAX

Growth Drivers

The global antidepressant and antipsychotic markets exhibit sustained expansion, driven by rising prevalence of bipolar disorder and major depressive disorder (MDD). According to Fortune Business Insights, the global bipolar disorder market size was valued at USD 997 million in 2020 and is projected to reach USD 1.33 billion by 2028, growing at a CAGR of 4.2% [1].

SYMBYAX positions itself as a targeted therapy for treatment-resistant cases, an increasingly significant patient segment. The drug's unique combination therapy offers advantages over monotherapy, including improved symptom control, which aligns with clinical guidelines favoring multidrug regimens for complex psychiatric conditions.

Competitive Landscape

The therapeutic arena for bipolar disorder and TRD is densely populated with monotherapies and combination agents. Key competitors include:

• Abilify (aripiprazole): Approved as an adjunct for depression; widely prescribed for bipolar disorder.
• Quetiapine (Seroquel): Approved for bipolar depression; high prescription volume.
• Lurasidone (Latuda): Approved for bipolar disorder and schizophrenia.
• Olanzapine monotherapy: For bipolar episodes; related in mechanism to SYMBYAX’s olanzapine component.

While newer agents like brexpiprazole and lumateperone enter the market, SYMBYAX’s niche rests in its established efficacy in TRD and bipolar disorder.

Regulatory and Prescribing Trends

The FDA approved SYMBYAX in 2009, with subsequent label updates emphasizing its effectiveness in bipolar depression and TRD. Clinical guidelines increasingly endorse combination therapy in treatment-resistant cases, influencing prescriber comfort and adoption.

However, concerns over metabolic side effects associated with olanzapine, including weight gain and diabetes risk, impose caution among clinicians, potentially limiting widespread use. Furthermore, regulatory scrutiny on antipsychotic safety profiles necessitates that prescribing decisions balance efficacy with safety considerations.

Market Dynamics Influencing SYMBYAX

Pricing and Reimbursement Strategies

As secondary or adjunctive therapy, SYMBYAX commands premium pricing due to its clinical benefits. However, insurance reimbursement policies, cost-effectiveness assessments, and competitive pricing influence market penetration. The drug's formulary positioning within managed care plans directly impacts sales volume.

Patent and Market Exclusivity

While patent expiration can erode market share for branded drugs, SYMBYAX benefits from a robust patent portfolio that extends exclusivity until at least 2024. The potential for patent challenges or biosimilar entries could threaten future revenues.

Physician Adoption and Patient Compliance

Physician familiarity with SYMBYAX, supported by clinical trial data demonstrating efficacy, drives prescribing. Patient compliance is affected by tolerability and side effect profiles, especially metabolic adverse events linked to olanzapine. Ongoing post-market surveillance influences prescribing confidence.

Pipeline and Innovation

Emerging combination therapies and advancements in personalized psychiatry could threaten SYMBYAX’s market position. Conversely, development of next-generation formulations—such as long-acting injectables—may expand its reach.

Financial Trajectory Analysis

Historical Revenue Performance

From its launch, SYMBYAX accounted for approximately USD 400-500 million in annual U.S. sales, reflecting its acceptance among clinicians managing TRD and bipolar disorder [2]. Its revenue trajectory has shown moderate growth, buoyed by increased diagnoses and expanded indications.

Forecasted Revenue Trends

Projections from industry analysts estimate a compound annual growth rate (CAGR) of 3-5% over the next five years, conditioned on:

• Stable or increased market share due to continued clinical adoption.
• Expansion into international markets, especially in Europe and Asia, where bipolar disorder awareness rises.
• Line extensions or formulations, such as higher-dose options or long-acting injectables.

The impact of patent expiry by 2024 could lead to a revenue decline unless mitigated by pipeline innovations or label extensions.

Risks and Opportunities

• Risks: Safety concerns leading to reduced prescribing, patent cliffs, unmet competition, and regulatory restrictions.
• Opportunities: Launch of new formulations, expanding indications, and strategic partnerships to penetrate emerging markets.

Financial Outlook

Assuming successful market retention and moderate growth, SYMBYAX could generate cumulative revenues exceeding USD 2.5 billion over the next five years before patent expiration pressures take hold. Post-expiration, generic competition is likely to reduce revenue share significantly unless differentiated formulation or novel indications are introduced.

Conclusion

SYMBYAX’s market dynamics are shaped by its positioning in the psychiatric treatment landscape, clinical efficacy, safety profile, and competitive forces. Its financial trajectory reflects a mature drug with steady revenue streams, tempered by patent expiry risks and safety concerns. Strategic developments—such as new formulations, expanded indications, and international expansion—are pivotal to sustaining and enhancing its market performance.

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Key Takeaways

• Market Positioning: SYMBYAX benefits from its niche in treatment-resistant bipolar disorder and depression, with a steady market presence supported by clinical guidelines favoring combination therapies.

• Competitive Landscape: A highly competitive environment with numerous monotherapies and combination drugs necessitates innovation and differentiation for sustained growth.

• Financial Outlook: Moderate revenue growth projected through increased adoption and geographic expansion, with potential declines following patent expiry unless mitigated by pipeline developments.

• Regulatory and Safety Considerations: Ongoing safety monitoring and regulatory compliance are crucial, especially concerning metabolic adverse events linked to olanzapine.

• Strategic Opportunities: Development of alternative formulations, label expansions, and international marketing representations could enhance future revenue streams.

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FAQs

1. What factors influence the prescribing of SYMBYAX in clinical practice?
Prescriber adoption hinges on demonstrated efficacy, safety profile, patient response, safety concerns related to metabolic risks, and insurance reimbursement policies.

2. How does patent expiration impact SYMBYAX’s market potential?
Patent expiry around 2024 exposes SYMBYAX to generic competition, potentially reducing revenues significantly unless new formulations, indications, or brand protections are introduced.

3. Are there ongoing clinical trials that could expand SYMBYAX’s indications?
Current research focuses on optimizing formulations and assessing safety. No major pending indications have been confirmed, but ongoing studies on schizophrenia and other mood disorders may influence future labeling.

4. How does the safety profile of SYMBYAX compare with its competitors?
While effective, SYMBYAX shares safety concerns tied to olanzapine, notably weight gain and metabolic risks, which may influence prescribing decisions relative to other agents with favorable safety profiles.

5. What is the potential for international markets to contribute to SYMBYAX’s growth?
Growing awareness and diagnosis of bipolar disorder in emerging markets present opportunities, contingent on regulatory approvals, pricing strategies, and local healthcare infrastructure.

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Sources:

[1] Fortune Business Insights. (2022). Bipolar Disorder Market Size, Share & Industry Analysis.
[2] IQVIA. (2021). Pharmaceutical Market Data and Trends Report.