Ziprasidone hydrochloride - Generic Drug Details

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

Ziprasidone hydrochloride is the generic ingredient in two branded drugs marketed by Viatris, Apotex, Aurobindo Pharma, Chartwell Rx, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms Ltd, Mylan, Sandoz Inc, Zydus Lifesciences, and Pfizer Inc, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for ziprasidone hydrochloride. Twenty suppliers are listed for this compound.

Summary for ziprasidone hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	11
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	146
Patent Applications:	530
What excipients (inactive ingredients) are in ziprasidone hydrochloride?	ziprasidone hydrochloride excipients list
DailyMed Link:	ziprasidone hydrochloride at DailyMed

Recent Clinical Trials for ziprasidone hydrochloride

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

Sponsor	Phase
First Affiliated Hospital Xi'an Jiaotong University	N/A
Shanghai Mental Health Center	Phase 4
Shanghai Jiao Tong University School of Medicine	Phase 4

See all ziprasidone hydrochloride clinical trials

Pharmacology for ziprasidone hydrochloride

Drug Class

Atypical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for ziprasidone hydrochloride

N05AE	Indole derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for ZIPRASIDONE HYDROCHLORIDE

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 ziprasidone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apotex	ZIPRASIDONE HYDROCHLORIDE	ziprasidone hydrochloride	CAPSULE;ORAL	077561-002	Mar 2, 2012	AB	RX	No	No
Lupin Pharms	ZIPRASIDONE HYDROCHLORIDE	ziprasidone hydrochloride	CAPSULE;ORAL	077560-003	Mar 2, 2012	AB	RX	No	No
Sandoz Inc	ZIPRASIDONE HYDROCHLORIDE	ziprasidone hydrochloride	CAPSULE;ORAL	077562-002	Jun 1, 2012	AB	RX	No	No
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-002	Feb 5, 2001	AB	RX	Yes	No

Expired US Patents for ziprasidone hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer Inc	GEODON	ziprasidone hydrochloride	SUSPENSION;ORAL	021483-001	Mar 29, 2006
Pfizer Inc	GEODON	ziprasidone hydrochloride	SUSPENSION;ORAL	021483-001	Mar 29, 2006
Viatris	GEODON	ziprasidone hydrochloride	CAPSULE;ORAL	020825-002	Feb 5, 2001
Pfizer Inc	GEODON	ziprasidone hydrochloride	SUSPENSION;ORAL	021483-001	Mar 29, 2006

Market Dynamics and Financial Trajectory for Ziprasidone Hydrochloride

Last updated: July 28, 2025

Introduction

Ziprasidone hydrochloride, marketed under the brand name Geodon among others, is an atypical antipsychotic primarily prescribed for schizophrenia and bipolar disorder management. Its unique pharmacological profile, market positioning, and evolving regulatory landscape influence its commercial trajectory. Understanding current market dynamics and financial prospects for ziprasidone hydrochloride necessitates a comprehensive analysis of technical aspects, competitive landscape, regulatory considerations, and emerging market trends.

Pharmacological Profile and Clinical Positioning

Ziprasidone exhibits high affinity for dopamine D2 and serotonin 5-HT2A receptors, alongside activity at other serotonergic and adrenergic receptors. Its relatively favorable side effect profile—particularly lower metabolic adverse events compared to atypical antipsychotics like risperidone and olanzapine—supports its clinical usage, especially in patients where metabolic risk is a concern [1].

However, its pharmacokinetic limitations, such as the need for twice-daily dosing and the requirement for careful cardiac monitoring due to potential QT interval prolongation, influence prescriber preference and market adoption.

Market Size and Revenue Landscape

The global antipsychotic drugs market was valued at approximately USD 15 billion in 2021 and is projected to grow at a CAGR of 3-4% through 2030, driven by increasing prevalence of schizophrenia and bipolar disorder, particularly in emerging markets [2]. Ziprasidone’s market share remains relatively modest compared to dominant agents like risperidone and aripiprazole, owing partly to its dosing complexities and safety profile considerations.

In 2022, branded sales of ziprasidone globally were estimated to approximate USD 350 million. This figure reflects moderate market penetration, driven mainly by North American and European markets, with growth prospects constrained by generic competition and the emergence of newer therapies.

Competitive Dynamics

The antipsychotics segment is characterized by extensive generic competition following patents’ expiry for several key drugs. Ziprasidone’s patent status varies across jurisdictions; in the US, patent exclusivity ended in 2017, leading to increased price erosion and generic entry. This has significantly impacted revenue streams for original manufacturers, notably Pfizer and Teva.

Emerging drugs with novel mechanisms—such as brexpiprazole and cariprazine—pose competitive challenges, offering comparable efficacy with improved tolerability or dosing regimens [3]. Additionally, the shift toward long-acting injectable formulations for adherence management influences market shares.

Regulatory Environment

Regulatory oversight notably includes safety warnings related to QT prolongation, which has prompted updates to prescribing information and post-marketing surveillance requirements. These safety concerns impact clinician prescribing behavior and considerations for broad market adoption.

Furthermore, regulatory pathways for biosimilars and generics accelerate competitive entry, diluting brand-specific revenue and pressuring profit margins for originators.

Pricing Strategies and Market Access

Pricing analysis reveals significant discounting in key markets. In the US, list prices for ziprasidone are often subject to rebates and formularies negotiations, leading to net prices substantially lower than initial list prices.

Market access challenges include insurance formulary restrictions due to safety considerations and competition from lower-cost generics. These factors require strategic engagement with payers and healthcare providers to sustain market presence.

Emerging Trends and Future Outlook

1. Expansion into New Indications: Currently approved mainly for schizophrenia and bipolar disorder, exploratory research into ziprasidone’s efficacy for other psychiatric conditions remains ongoing but limited, constraining near-term growth.

2. Formulation Innovations: Efforts to develop long-acting injectable formulations could address adherence issues, expanding patient populations and differentiating the drug in a crowded market.

3. Personalized Medicine: Advances in pharmacogenomics may influence prescribing patterns, favoring drugs with favorable safety profiles tailored to individual genetic backgrounds—areas where ziprasidone’s profile could provide advantages.

4. Regulatory and Patent Strategies: Companies seeking lifecycle management through patent extensions and new formulations may influence future market dynamics.

5. Market Penetration in Emerging Economies: As awareness and healthcare infrastructure improve, opportunities in emerging markets could bolster revenues, contingent on cost competitiveness and regulatory approvals.

Financial Trajectory

The financial outlook for ziprasidone is marked by revenue stagnation post-generic entry, with potential recovery hinges on strategic product differentiation, formulation innovations, and expanding indications. The current trend sees a shift towards generic sales, with major revenues declining by double digits annually in mature markets.

Projections indicate a continued decline in global sales unless counteracted by new formulation approvals and market expansion strategies. The market's focus on cost containment and safety profile improvements will be critical to sustaining profitability for pioneering firms.

Conclusion

Ziprasidone hydrochloride's market dynamics are shaped by its pharmacological niche, the competitive landscape, patent expirations, safety considerations, and evolving treatment paradigms. While the current financial trajectory suggests stagnation or decline driven by generic competition, opportunities exist through innovation, expanded indications, and strategic market access initiatives. Stakeholders must adapt to a landscape where safety, efficacy, and consumer preferences are increasingly central.

---

Key Takeaways

• Market Challenges: Patent expiration and generic competition have significantly eroded revenue streams for ziprasidone, with US patent expiry in 2017 marking a turning point.
• Safety Profile Influence: QT prolongation risk poses safety concerns that influence market acceptance and prescribing practices.
• Innovation Opportunities: Development of long-acting formulations and exploration of new indications could rejuvenate growth prospects.
• Emerging Markets: Expanding adoption in emerging economies presents a growth avenue contingent on cost competitiveness.
• Strategic Focus: Differentiation through pharmacogenomics and safety profile optimization remains crucial for sustaining market relevance.

---

FAQs

1. What factors primarily influence the market share of ziprasidone hydrochloride?
The market share is influenced by safety concerns (notably QT prolongation), dosing regimens requiring multiple daily doses, increasing generic competition following patent expiry, and the emergence of newer antipsychotics with improved tolerability.

2. How does safety regulation impact ziprasidone's market prospects?
Safety warnings and monitoring requirements, especially concerning cardiac risks, can restrict usage, influence prescriber preferences, and limit broader market acceptance, thus affecting sales.

3. Are there ongoing efforts to improve ziprasidone formulations or delivery methods?
Yes, research into long-acting injectable formulations is ongoing, intending to address adherence challenges, which could offer a competitive advantage.

4. What emerging markets present opportunities for ziprasidone?
Countries with increasing mental health awareness and improving healthcare infrastructure, such as India, China, and Brazil, are potential growth markets, provided price points align with local affordability.

5. How does the competitive landscape affect future revenues for ziprasidone?
High patent expiration and the availability of lower-cost generics compress revenues. Innovations and strategic differentiation are necessary to regain or sustain market share amid intense competition.

---

References

[1] Stahl, S. M., Stahl's Essential Psychopharmacology, 4th Edition, Cambridge University Press, 2013.
[2] MarketsandMarkets, "Antipsychotics Market by Drug Type, Application, and Region," 2022.
[3] Citrome, L., "Newer and emerging antipsychotics: focus on brexpiprazole," Australian & New Zealand Journal of Psychiatry, 2020.