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 PHARMA LTD 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:	81
Clinical Trials:	48
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

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

International Patents for GEODON

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

Country	Patent Number	Title	Estimated Expiration
Germany	69727218
Estonia	200100633
Japan	3441676
New Zealand	508303	Mesylate trihydrate salt of 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)-ethyl)-6-chloro-1,3-dihydro-2(1H)-indol-2-one (ziprasidone) useful as a dopamine D2 antagonist

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

GEODON Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GEODON (Ziprasidone)

Introduction to GEODON (Ziprasidone)

GEODON, known generically as ziprasidone, is an atypical antipsychotic medication used primarily for the treatment of schizophrenia and acute mania or mixed states associated with bipolar disorder. Its immediate release intramuscular injection form is also approved for acute agitation in people with schizophrenia[3].

Market Drivers

Growing Emphasis on Personalized Medicine

The ziprasidone market is significantly driven by the growing emphasis on personalized medicine. Healthcare providers are increasingly tailoring treatment plans to individual patients, which includes psychiatric conditions such as schizophrenia and bipolar disorder. This trend aligns well with ziprasidone's flexible treatment options, available in both oral and injectable forms[1].

Changes in Mental Health Care Delivery

The shift towards deinstitutionalization and community-based mental health care has increased the demand for outpatient treatments. Ziprasidone's availability in various forms supports this trend, making it a preferred choice for patients receiving care outside traditional inpatient settings[1].

Advancements in Research and Treatment

Ongoing research into the neurological underpinnings of mental illnesses has led to better understanding and more targeted treatments. This has further bolstered the market for ziprasidone, as it is part of the newer generation of antipsychotic medications that aim to reduce side effects and improve patient quality of life[1].

Expanding Geriatric Population and Healthcare Investments

The growing geriatric population, which often requires mental health support, and increasing healthcare investments are additional drivers. These factors contribute to better access to healthcare facilities and a greater acceptance of mental health treatments, reducing stigma and increasing demand for antipsychotic drugs like ziprasidone[4].

Market Restraints

Competition from Alternative Antipsychotics

The market for ziprasidone faces significant competition from other antipsychotic medications that may have better efficacy profiles. This competition can impact the sales and market share of ziprasidone, as healthcare providers and patients may opt for alternative treatments[4].

Stringent Regulatory Requirements and High R&D Costs

Stringent regulatory requirements and the high cost of research and development (R&D) pose challenges to the market. These factors can affect the pricing strategy and the overall profitability of ziprasidone, making it essential for companies to invest strategically in R&D and regulatory compliance[4].

Global Disparity in Mental Health Infrastructure

The global disparity in mental health treatment infrastructure affects the distribution and sales of ziprasidone. In regions with underdeveloped healthcare systems, access to such medications can be limited, hindering market growth[4].

Market Opportunities

Innovative Formulations and Delivery Systems

There is a significant opportunity in developing extended-release formulations of ziprasidone, which can cater to patients seeking reduced dosing frequency. Additionally, integrating ziprasidone delivery with telemedicine services through partnerships with digital health companies can enhance patient engagement and treatment adherence[4].

Educational Campaigns and Strategic Partnerships

Innovative marketing campaigns to educate psychiatrists and healthcare providers about the benefits of ziprasidone can increase its adoption. Strategic partnerships with research institutions to explore novel treatment pathways and drug delivery systems can also create new growth avenues[4].

Financial Trajectory

Revenue Projections and Market Size

The ziprasidone market was valued at a significant amount in 2017 and is projected to grow substantially by 2025. This growth is driven by the increasing demand for mental health treatments and the expanding healthcare infrastructure[3].

Cost and Revenue Analysis

Setting up a ziprasidone manufacturing plant involves detailed project economics, including capital investments, operating expenses, income projections, and financial analysis. The report on setting up a ziprasidone manufacturing plant provides insights into capital expenditure (CapEx), operating expenditure (OpEx), taxation, depreciation, liquidity analysis, profitability analysis, payback period, and net present value (NPV)[1].

Profitability and ROI

The profitability of ziprasidone is influenced by various factors, including the cost of raw materials, utility requirements, and regulatory compliance. Companies in this market need to balance these costs with the revenue generated to achieve a favorable return on investment (ROI) and NPV. The market's competitive nature necessitates continuous innovation and strategic investments to maintain profitability[1].

Key Players and Market Competition

List of Key Players

The ziprasidone market is competitive and includes key players such as Pfizer Inc., Sandoz AG, Lupin Pharmaceuticals, Inc., Mylan Pharmaceuticals, Apotex, Dr. Reddy's Laboratories Ltd., Wockhardt, and Aurobindo Pharma USA. These companies focus on differentiation through product efficacy and brand reputation to maintain their market share[3].

Porter’s Five Forces Analysis

The Porter’s Five Forces analysis helps in understanding the competitive position of businesses in the ziprasidone market. This model identifies the strength of the current competitive position and potential repositioning opportunities. It highlights the power dynamics, including the threat of new entrants, the bargaining power of suppliers and buyers, the threat of substitute products, and the intensity of competitive rivalry[4].

Regulatory and Approval Processes

Regulatory Procedures and Approvals

Setting up a ziprasidone manufacturing plant requires navigating through detailed regulatory procedures and obtaining necessary approvals. The report on setting up a ziprasidone manufacturing plant provides a comprehensive list of certifications required and financial assistance available, which is crucial for compliance and operational efficiency[1].

Conclusion

The market dynamics for GEODON (ziprasidone) are shaped by several key factors, including the growing emphasis on personalized medicine, changes in mental health care delivery, advancements in research, and ongoing efforts to enhance treatment efficacy and patient quality of life. While the market faces challenges such as competition and regulatory hurdles, there are significant opportunities for growth through innovative formulations, strategic partnerships, and educational campaigns.

Key Takeaways

• Growing Demand: The demand for ziprasidone is driven by the increasing need for mental health treatments and the shift towards community-based care.
• Innovation: Developing extended-release formulations and integrating with telemedicine services can enhance market growth.
• Competition: The market is competitive, with several key players focusing on product efficacy and brand reputation.
• Regulatory Compliance: Navigating regulatory procedures and obtaining necessary approvals are crucial for manufacturing and distribution.
• Financial Performance: The financial trajectory of ziprasidone involves careful management of costs and revenues to achieve favorable ROI and NPV.

Frequently Asked Questions (FAQs)

1. What is GEODON (ziprasidone) used for?

GEODON (ziprasidone) is used for the treatment of schizophrenia and acute mania or mixed states associated with bipolar disorder. It is also approved for acute agitation in people with schizophrenia.

2. What are the key drivers of the ziprasidone market?

The key drivers include the growing emphasis on personalized medicine, changes in mental health care delivery, advancements in research, and increasing healthcare investments.

3. Who are the major players in the ziprasidone market?

Major players include Pfizer Inc., Sandoz AG, Lupin Pharmaceuticals, Inc., Mylan Pharmaceuticals, Apotex, Dr. Reddy's Laboratories Ltd., Wockhardt, and Aurobindo Pharma USA.

4. What are the main challenges facing the ziprasidone market?

The main challenges include competition from alternative antipsychotics, stringent regulatory requirements, high R&D costs, and global disparities in mental health infrastructure.

5. How can companies in the ziprasidone market enhance their growth?

Companies can enhance their growth by developing innovative formulations, integrating with telemedicine services, and engaging in educational campaigns to increase adoption. Strategic partnerships with research institutions and focus on patient-centric care models are also crucial.

Cited Sources:

1. IMARC Group. Ziprasidone (Geodon) Manufacturing Plant Project Report 2024: Industry Trends, Plant Setup, Machinery, Raw Materials, Investment Opportunities, Cost and Revenue.
2. The GEO Group. The GEO Group Reports Fourth Quarter and Full Year 2023 Results.
3. OpenPR. Ziprasidone Market Fabulous Opportunities, Complete Analysis of Current Industry Trends.
4. 360iResearch. Ziprasidone Drugs Market Size & Share 2025-2030.