Ziprasidone mesylate - Generic Drug Details

What are the generic sources for ziprasidone mesylate and what is the scope of freedom to operate?

Ziprasidone mesylate is the generic ingredient in two branded drugs marketed by Viatris, Gland, MSN, and Steriscience, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Seven suppliers are listed for this compound.

Summary for ziprasidone mesylate

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	7
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	1
Patent Applications:	387
What excipients (inactive ingredients) are in ziprasidone mesylate?	ziprasidone mesylate excipients list
DailyMed Link:	ziprasidone mesylate at DailyMed

Recent Clinical Trials for ziprasidone mesylate

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

Sponsor	Phase
Yang Fude	Phase 4
Pfizer	Phase 4

See all ziprasidone mesylate clinical trials

Pharmacology for ziprasidone mesylate

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for ziprasidone mesylate

N05AE	Indole derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for ziprasidone mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viatris	GEODON	ziprasidone mesylate	POWDER;INTRAMUSCULAR	020919-001	Jun 21, 2002	AP	RX	Yes	Yes
Msn	ZIPRASIDONE MESYLATE	ziprasidone mesylate	POWDER;INTRAMUSCULAR	216091-001	Sep 15, 2022	AP	RX	No	No
Gland	ZIPRASIDONE MESYLATE	ziprasidone mesylate	POWDER;INTRAMUSCULAR	211908-001	Dec 26, 2019	AP	RX	No	No
Steriscience	ZIPRASIDONE MESYLATE	ziprasidone mesylate	POWDER;INTRAMUSCULAR	217595-001	Sep 3, 2025	AP	RX	No	No

Expired US Patents for ziprasidone mesylate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viatris	GEODON	ziprasidone mesylate	POWDER;INTRAMUSCULAR	020919-001	Jun 21, 2002
Viatris	GEODON	ziprasidone mesylate	POWDER;INTRAMUSCULAR	020919-001	Jun 21, 2002
Viatris	GEODON	ziprasidone mesylate	POWDER;INTRAMUSCULAR	020919-001	Jun 21, 2002
Viatris	GEODON	ziprasidone mesylate	POWDER;INTRAMUSCULAR	020919-001	Jun 21, 2002
Viatris	GEODON	ziprasidone mesylate	POWDER;INTRAMUSCULAR	020919-001	Jun 21, 2002
Viatris	GEODON	ziprasidone mesylate	POWDER;INTRAMUSCULAR	020919-001	Jun 21, 2002

Market Dynamics and Financial Trajectory for Ziprasidone Mesylate

Last updated: July 28, 2025

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Introduction

Ziprasidone mesylate, an atypical antipsychotic medication developed by Eli Lilly and Co., is primarily used to treat schizophrenia and bipolar disorder. Its market dynamics and financial trajectory are shaped by its clinical efficacy, competitive landscape, regulatory environment, and evolving healthcare needs. This analysis provides a comprehensive overview, emphasizing key drivers influencing its market performance and future prospects.

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Pharmacological Profile and Therapeutic Positioning

Ziprasidone operates as a dopamine D2 and serotonin 5-HT2A receptor antagonist, with additional activity at other serotonergic and adrenergic receptors. Its unique pharmacodynamic profile offers a favorable side-effect profile relative to first-generation antipsychotics, notably reduced extrapyramidal symptoms. It is administered orally and via intramuscular injections, catering to both chronic management and acute agitation in psychiatric settings.

Clinical trials demonstrate its efficacy in symptom control, with a tolerable safety profile that has positioned it as an alternative to other atypical antipsychotics like risperidone and olanzapine. However, its relatively strict dosing requirements and concerns about QTc prolongation have limited broader adoption.

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Market Landscape and Competitive Dynamics

Global Market Size and Growth

The global antipsychotic market, valued at approximately USD 12.5 billion in 2022, is projected to grow at a CAGR of around 3.8% through 2030, driven by rising prevalence of schizophrenia and bipolar disorder, expanding mental health awareness, and improvements in diagnosis and treatment access [1].

Key Competitors

Ziprasidone competes in a crowded market with notable players:

• Risperidone (Risperdal) by Janssen
• Olanzapine (Zyprexa) by Lilly
• quetiapine (Seroquel) by AstraZeneca
• Aripiprazole (Abilify) by Otsuka and Bristol-Myers Squibb
• Lurasidone (Latuda) by Lilly

While these agents share therapeutic indications, differences in side-effect profiles, dosing convenience, and patent status influence their market share. Ziprasidone's relative clinical niche is as an alternative for patients sensitive to metabolic side effects—although its QTc concern constrains its use in certain populations.

Formulation and Patent Status

Lilly's patent protection for ziprasidone expired in several key markets between 2017 and 2020, leading to increased generic penetration. The availability of cost-effective generic versions has pressured branded sales, especially in price-sensitive markets. However, authorized generics and improved formulations or combination therapies could mitigate revenue declines.

Regulatory Environment and Labeling

Initially approved by the FDA in 2001, ziprasidone's regulatory journey includes labels emphasizing QTc prolongation risk. Ongoing pharmacovigilance and updated warnings influence clinician prescribing habits. Regulations in emerging markets differ, often affecting drug accessibility and market growth potential.

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Market Drivers and Challenges

Drivers

• Rising Incidence of Psychotic Disorders: The increasing global prevalence of schizophrenia (approximately 20 million people worldwide) and bipolar disorder promotes steady demand.
• Growing Awareness and Diagnosis: Mental health awareness initiatives expand diagnosis rates, especially in developing regions.
• Advancements in Formulations: Innovative delivery methods and combination regimens may offer growth avenues.
• Shift Toward Personalized Psychiatry: Tailored treatments targeting individual patient profiles favor drugs with favorable safety profiles, favoring ziprasidone in select cases.

Challenges

• Generic Competition and Price Erosion: The expiration of patents led to commoditization, significantly impacting revenue streams.
• Safety Concerns: QTc prolongation risk restricts broader use, necessitating careful patient selection and limiting market expansion.
• Market Penetration Limitations: Clinicians often prefer agents with more established safety profiles or superior convenience, limiting ziprasidone's adoption.
• Regulatory Constraints: Variability across jurisdictions complicates global expansion efforts.

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Financial Trajectory and Revenue Outlook

Historical Revenue Performance

Pre-generic era, ziprasidone contributed significantly to Lilly's revenues within its psychiatric portfolio, peaking in the late 2000s. Post-patent expiry, sales declined precipitously, mirroring trends observed with other branded antipsychotics facing generic entry [2].

Recent Trends and Projections

• Generic Market Impact: The U.S. and European markets experienced an 80% decline in ziprasidone sales since 2017 due to generic competition [3].
• Emerging Market Potential: In regions with delayed patent protections and lower drug prices, ziprasidone maintains a niche customer base, possibly stabilizing revenues.
• Innovative Formulations and Indications: Limited pipeline development restricts revenue growth prospects. However, off-label uses or new formulations could resuscitate interest.

Future Revenue Scenarios

Forecasts suggest that unless new formulations, combination therapies, or indications are developed, ziprasidone's revenue contribution will remain marginal within Lilly's portfolio. Global pharmaceutical industry trends favor newer atypical agents with better safety profiles and dosing convenience, further challenging ziprasidone's market share.

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Regulatory and Market Opportunities

• Pharmacovigilance and Label Optimization: Enhanced safety monitoring could expand clinician confidence.
• Combination Formulations: Combining ziprasidone with medications addressing unmet needs, such as depressive symptoms in bipolar disorder, could open new avenues.
• Extended Indications: Exploring uses in treatment-resistant cases or other psychiatric conditions might revive market interest.
• Regional Expansion: Penetrating emerging markets with tailored pricing strategies could sustain revenues.

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Strategic Implications

The pharmaceutical industry is shifting focus toward drugs with improved safety and dosing convenience. Ziprasidone's future hinges on innovation—either through formulation advancements, new therapeutic indications, or repositioning. Patent expirations compel companies to adapt through lifecycle management strategies, including line extensions or combination therapies.

In the current landscape, investors and stakeholders should consider the drug’s limited growth prospects in mature markets but recognize potential in niche segments and emerging markets. Partnerships, licensing deals, or reformulation investments could alter its financial trajectory.

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Conclusion

Ziprasidone mesylate’s market dynamics reflect broader trends in the antipsychotic landscape: fierce generic competition, safety profile considerations, and shifting clinician preferences. Its revenue trajectory post-patent expiry underscores the importance of continued innovation and strategic repositioning. While current outlooks suggest limited growth, targeted regional expansion and formulation innovation may offer pathways to maintaining or modestly enhancing its market relevance.

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Key Takeaways

• The patent expiry significantly diminished ziprasidone’s revenue, with generic competition eroding market share.
• Safety concerns, particularly QTc prolongation, restrict its widespread use compared to competitors.
• The global rise in mental health awareness supports steady but limited demand in niche markets.
• Innovation, such as combination therapies or new formulations, is essential for future growth.
• Emerging markets present untapped potential due to delayed patent expirations and price sensitivities.

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FAQs

1. What factors primarily influence ziprasidone’s declining revenue post-patent expiry?
Generic competition, safety concerns (notably QTc prolongation), and clinician preferences for alternative agents have led to reduced prescriptions, significantly impacting sales.

2. Are there ongoing developments to improve ziprasidone’s safety profile?
Currently, no major reformulations are in advanced development; however, pharmacovigilance and regulatory updates aim to enhance safety monitoring, which may influence prescribing.

3. Can ziprasidone find a niche market despite stiff competition?
Yes. In populations sensitive to metabolic side effects or in regions with limited access to newer agents, ziprasidone may sustain modest demand.

4. What are potential future strategies for extending ziprasidone’s market life?
Strategies include developing combination formulations, pursuing new indications such as treatment-resistant psychiatric conditions, and expanding into emerging markets.

5. How does the current competitive landscape affect innovators developing new atypical antipsychotics?
The crowded market and safety concerns mean new entrants need to demonstrate superior efficacy, safety, or convenience to capture significant share, challenging the viability of older drugs like ziprasidone in future pipelines.

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References

[1] MarketWatch. (2023). Global Antipsychotics Market Size, Share & Trends Analysis Report.
[2] Eli Lilly and Co. Annual Reports. (2017-2022).
[3] IQVIA. (2022). Drug Sales Reports and Market Share Data.