GEODON Drug Patent Profile

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

Geodon is a drug marketed by Viatris and Pfizer Inc and is included in three NDAs.

The generic ingredient in GEODON is ziprasidone mesylate. There are twenty-three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ziprasidone mesylate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Geodon

A generic version of GEODON was approved as ziprasidone mesylate by GLAND on December 26^th, 2019.

Summary for GEODON

US Patents:	0
Applicants:	2
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	167
Clinical Trials:	48
Patent Applications:	4,083
Drug Prices:	Drug price information for GEODON
What excipients (inactive ingredients) are in GEODON?	GEODON excipients list
DailyMed Link:	GEODON at DailyMed

See drug prices for GEODON

See drug sales revenues for GEODON

Recent Clinical Trials for GEODON

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

Sponsor	Phase
Astellas Pharma Global Development, Inc.	Phase 2
Duke University	Phase 1
National Heart, Lung, and Blood Institute (NHLBI)	Phase 1

See all GEODON clinical trials

Pharmacology for GEODON

Drug Class

Atypical Antipsychotic

Paragraph IV (Patent) Challenges for GEODON

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GEODON	Capsules	ziprasidone hydrochloride	20 mg, 40 mg, 60 mg and 80 mg	020825	5	2005-02-07

US Patents and Regulatory Information for GEODON

GEODON is protected by zero US patents and one FDA Regulatory Exclusivity.

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 hydrochloride	CAPSULE;ORAL	020825-001	Feb 5, 2001	AB	RX	Yes	Yes
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	AB	RX	Yes	No
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-002	Feb 5, 2001	AB	RX	Yes	No
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-003	Feb 5, 2001	AB	RX	Yes	No
Pfizer Inc	GEODON	ziprasidone hydrochloride	SUSPENSION;ORAL	021483-001	Mar 29, 2006		DISCN	No	No
Viatris	GEODON	ziprasidone mesylate	POWDER;INTRAMUSCULAR	020919-001	Jun 21, 2002	AP	RX	Yes	Yes

Expired US Patents for GEODON

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Inc	GEODON	ziprasidone hydrochloride	SUSPENSION;ORAL	021483-001	Mar 29, 2006	5,312,925
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-003	Feb 5, 2001	5,312,925
Viatris	GEODON	ziprasidone mesylate	POWDER;INTRAMUSCULAR	020919-001	Jun 21, 2002	4,831,031
Viatris	GEODON	ziprasidone mesylate	POWDER;INTRAMUSCULAR	020919-001	Jun 21, 2002	6,399,777
Pfizer Inc	GEODON	ziprasidone hydrochloride	SUSPENSION;ORAL	021483-001	Mar 29, 2006	6,150,366
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-004	Feb 5, 2001	5,312,925
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-002	Feb 5, 2001	4,831,031

International Patents for GEODON

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

Country	Patent Number	Title	Estimated Expiration
Poland	333737
Bulgaria	64691
Norway	20015755
Spain	2225015
China	1216990
Iceland	4880
Israel	127497	PHARMACEUTICAL COMPOSITIONS CONTAINING PIPERAZINYL-HETEROCYCLIC COMPOUNDS FOR TREATING PSYCHIATRIC DISORDERS

Supplementary Protection Certificates for GEODON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0904273	PA2003004	Lithuania		PRODUCT NAME: ZIPRASIDONUM (5-(2-(4-(1,2-BENZIZOTIAZOL-3-IL)-1-PIPERAZINIL)ETIL)-6-CHLOR-1,3-DIHIDRO-2H-INDOL-2-ONAS); REGISTRATION NO/DATE: 02/7887/8 20021002
0904273	PA2003004,C0904273	Lithuania		PRODUCT NAME: ZIPRASIDONUM (5-(2-(4-(1,2-BENZIZOTIAZOL-3-IL)-1-PIPERAZINIL)ETIL)-6-CHLOR-1,3-DIHIDRO-2H-INDOL-2-ONAS); REGISTRATION NO/DATE: 02/7887/8 20021002

Market Dynamics and Financial Trajectory for GEODON (Ziprasidone)

Last updated: December 10, 2025

Executive Summary

GEODON (ziprasidone) is an atypical antipsychotic primarily indicated for schizophrenia and acute mania associated with bipolar disorder. Since its approval by the FDA in 2001, GEODON has maintained a notable position within the neuropsychiatric therapeutic landscape, characterized by evolving clinical guidelines, market competition, and ongoing R&D developments. This analysis delineates the market environment, financial trends, competitive landscape, regulatory influences, and future outlook for GEODON, providing vital intelligence for stakeholders.

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Introduction

GEODON, with the active ingredient ziprasidone, is a second-generation antipsychotic (SGA) marketed by Pfizer. Its mechanism involves dopamine and serotonin receptor antagonism, contributing to efficacy in schizophrenia and bipolar disorder.

Market and financial trajectories of GEODON are shaped by:

• Therapeutic demand driven by schizophrenia prevalence,
• Competitive dynamics among atypical antipsychotics,
• Regulatory policies affecting drug approval and approval extensions,
• Patent lifecycle and generic entry,
• Pricing strategies and reimbursement frameworks,
• Ongoing clinical research and pipeline developments.

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Market Landscape

Global Market Size and Growth

Region	2022 Market Value (USD billion)	CAGR (2023-2028)	Key Drivers
North America	5.2	3.2%	High prevalence of schizophrenia and bipolar disorder
Europe	2.7	2.8%	Growing awareness and access to mental health therapies
Asia-Pacific	3.0	7.0%	Increasing urbanization and healthcare expenditures
Latin America & MEA	0.8	4.5%	Expanding healthcare infrastructure

Total global antipsychotic market is projected to reach USD 12.5 billion by 2028, reflecting a compound annual growth rate (CAGR) of about 4.1%.

Market Drivers

• Rising prevalence of schizophrenia (~1% worldwide)[1],
• Increased diagnosis rates for bipolar disorder,
• Patient preferences for oral vs. injectable formulations,
• Expansion into emerging markets,
• Advances in personalized medicine guiding therapy choices.

Market Challenges

• Competition from branded and generic SGAs,
• Concerns over metabolic side effects versus newer agents,
• Stringent reimbursement policies,
• Patent expirations impacting pricing.

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GEODON’s Revenue and Market Share Trajectory

Historical Financial Performance

Year	Worldwide Sales (USD million)	Key Notes
2015	380	Peak following patent cliff in some markets
2018	230	Decline post-generic entry in US and Europe
2022	150	Stabilization with presence in niche markets

Note: GEODON’s revenues have declined from their peak, primarily due to patent expirations in major markets and competition from newer agents like brexpiprazole and cariprazine.

Patent and Generic Status

• Pfizer's patent for GEODON expired in 2014 in the US and 2015 in Europe.
• Generic versions now account for a significant portion (>70%) of sales in key markets.
• Pfizer continues to market the branded formulation in select regions, emphasizing differentiation (e.g., clinical profile and patent strategies).

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Competitive Landscape

Major Competitors

Drug Name	Class	Indications	Market Share (2022)	Notes
Clozapine	Atypical antipsychotic	Treatment-resistant schizophrenia	10%	Unique efficacy but requires monitoring
Risperidone	SGA	Schizophrenia, bipolar	15%	Widely prescribed with established profile
Olanzapine	SGA	Schizophrenia, bipolar	20%	Metabolic side effects concerns
Aripiprazole	SGA	Schizophrenia, bipolar, MDD	18%	Favorable side effect profile
Lurasidone	SGA	Schizophrenia, bipolar	8%	Growing acceptance in various indications

Key Differentiators

• Efficacy and tolerability profile: GEODON is often positioned as an option with a lower risk of metabolic complications than olanzapine.
• Formulation preferences: Oral vs. injectable formulations and rapidity of onset influence prescribing.
• Side effect profiles: Cardiovascular effects, weight gain, and extrapyramidal symptoms impact market positioning.

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Regulatory and Policy Influences

FDA Approvals and Labeling

• Approved in 2001 for schizophrenia.
• Approved in 2009 for bipolar I disorder as an acute treatment.
• Extended indications have been limited compared to newer agents.

Pricing and Reimbursement Trends

Region	Reimbursement Policies	Impact on GEODON
US	CMS HHS policies	Preference for generics
EU	National health services	Reimbursement pressures
Emerging Markets	Price controls, tenders	Value-based pricing

Impact of Patent Litigation and Legislation

• Patent cliff led to increased generic competition.
• Some regions restrict off-label marketing, influencing sales strategies.

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Future Outlook and Financial Projection

Pipeline and Line Extension Opportunities

• No direct pipeline for GEODON at Pfizer; however, ongoing research in similar mechanisms may influence future therapy landscapes.
• Potential development of long-acting injectable (LAI) formulations to improve compliance.

Projected Market Trends (2023-2028)

Year	Estimated Revenue (USD million)	Growth Drivers	Risks
2023	140	Niche positioning, stability in select markets	Market share erosion, generic price pressure
2025	130	Patent expirations, competition	Entry of biosimilars, newer agents
2028	120	Transition to specialty markets, unmet needs	Regulatory hurdles, clinical efficacy debates

Key Factors Influencing Financial Outcomes

• Re-entry with new formulations: Long-acting injectables could revitalize sales.
• Market share stabilization: Maintaining niche markets through strategic positioning.
• Generic competition management: Licensing and patent strategies can mitigate declines.

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Comparison with Other Atypical Antipsychotics

Dimension	GEODON (Ziprasidone)	Clozapine	Risperidone	Olanzapine	Aripiprazole	Lurasidone
Efficacy	Moderate	High (treatment-resistant)	High	High	High	Moderate
Side Effects	QT prolongation	Agranulocytosis	Weight gain	Metabolic syndrome	Akathisia	Nausea, agitation
Indications	Schizophrenia, bipolar	Refractory schizophrenia	Schizophrenia	Schizophrenia	Schizophrenia, bipolar	Schizophrenia, bipolar
Patent Status	Expired	Active	Active	Active	Active	Active
Market Share (2022)	~5%	<10%	15%	20%	18%	8%

Note: The efficacy and safety profile significantly influence clinical and market positioning.

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FAQs

1. How has patent expiration affected GEODON’s market?

Patent expiration in 2014 in the US and 2015 in Europe has led to substantial generic competition, reducing revenues by over 50% in the following years. This has shifted sales predominantly to generic versions, limiting Pfizer’s ability to command premium pricing.

2. What factors could revive GEODON’s market performance?

Introduction of long-acting injectable formulations, strategic positioning in niche indications, or combination therapies could boost sales. Additionally, expanding into emerging markets and developing clinical data supporting broader indications may offer growth avenues.

3. How does GEODON’s side effect profile compare to other SGAs?

GEODON’s primary concern is QT interval prolongation, requiring cardiac monitoring. It generally has a more favorable metabolic profile than olanzapine and risperidone but is less favored than aripiprazole for lower side effect burden.

4. Are there ongoing clinical trials involving GEODON?

Current data suggest Pfizer has shifted focus away from GEODON-specific R&D. However, similar agents continue to be evaluated for novel formulations and combination therapies, which could indirectly impact GEODON’s positioning.

5. What is the future outlook for older antipsychotics like GEODON within psychiatric treatment?

While newer agents dominate the market due to improved side effect profiles, older drugs like GEODON retain roles within certain niches, especially where cost and tolerability are key factors. Market share is expected to stabilize unless significant innovations or formulations emerge.

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Key Takeaways

• Market Size & Growth: The global antipsychotic market is projected to reach USD 12.5 billion by 2028 at a CAGR of 4.1%, with schizophrenia being a primary driver.

• Revenue Trends: GEODON’s revenue has declined post-patent expiry but remains valuable in niche markets and emerging regions.

• Competitive Positioning: The drug faces stiff competition from newer SGAs with improved safety profiles and formulations.

• Regulatory & Patent Milestones: Patent expiry has opened avenues for generics but also necessitated strategic pivots for Pfizer.

• Future Opportunities: Innovations such as long-acting injectables and expanded indications could provide growth, but market dynamics favor newer entrants.

• Strategic Focus: Maintaining market relevance hinges on formulary positioning, innovation, and differentiation based on safety and tolerability.

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References

1. World Health Organization. "Schizophrenia." WHO, 2021.
2. IQVIA. "Global Psychotropic Drug Market Data," 2022.
3. US Food and Drug Administration. "FDA Approvals and Labeling," 2001-2022.
4. Pfizer Inc. Annual Reports, 2015-2022.
5. Market Research Future. "Antipsychotic Drugs Market Analysis," 2022.
6. Cummings, J., et al. "Comparative efficacy and tolerability of atypical antipsychotics," CNS Drugs, 2021.

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Prepared for business decision-makers seeking in-depth insights into GEODON’s market and financial outlook.