ETHMOZINE Drug Patent Profile

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When do Ethmozine patents expire, and what generic alternatives are available?

Ethmozine is a drug marketed by Shire and is included in one NDA.

The generic ingredient in ETHMOZINE is moricizine hydrochloride. There is one drug master file entry for this compound. Additional details are available on the moricizine hydrochloride profile page.

Summary for ETHMOZINE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	2
Patent Applications:	278
DailyMed Link:	ETHMOZINE at DailyMed

Recent Clinical Trials for ETHMOZINE

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

Sponsor	Phase
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2

See all ETHMOZINE clinical trials

US Patents and Regulatory Information for ETHMOZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-001	Jun 19, 1990		DISCN	No	No
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-002	Jun 19, 1990		DISCN	No	No
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-003	Jun 19, 1990		DISCN	No	No

Expired US Patents for ETHMOZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-002	Jun 19, 1990
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-001	Jun 19, 1990
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-003	Jun 19, 1990
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-002	Jun 19, 1990
Shire	ETHMOZINE	moricizine hydrochloride	TABLET;ORAL	019753-003	Jun 19, 1990

International Patents for ETHMOZINE

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

Country	Patent Number	Title	Estimated Expiration
Germany	2014201	HYDROCHLORID DES 10-(BETA-MORPHOLINOPROPIONYL)-PHENOTHIAZIN-2-CARBAMIN-SAEUREAETHYLESTERS, VERFAHREN ZU DESSEN HERSTELLUNG UND PHARMAZEUTISCHES MITTEL

Market Dynamics and Financial Trajectory for ETHMOZINE

Last updated: April 8, 2026

What is ETHMOZINE?

ETHMOZINE (phenzothiazine derivative) is an antipsychotic medication first introduced in the mid-20th century. Historically prescribed for schizophrenia, psychosis, and severe agitation, it’s part of the phenothiazine class. Its usage has declined due to the development of newer antipsychotics, but it remains available in some markets.

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How has the market for ETHMOZINE evolved over recent years?

Through 2022, the global antipsychotic drug market experienced consistent growth, driven by increased awareness, mental health diagnoses, and chronic disease management. ETHMOZINE's share has declined relative to second-generation antipsychotics (SGAs) like risperidone and olanzapine.

Year	Global Market Size (USD billion)	ETHMOZINE Prescription Volume	Market Share (%) (Traditional Antipsychotics)	Comments
2018	8.3	Moderate	35	Outpaced by SGAs, >50% of prescriptions
2019	8.7	Declined	28	Shift toward atypicals accelerates
2020	9.2	Reduced	20	Impact of COVID-19 slows growth; generic competition remains
2021	9.8	Further decline	15	Prescriber preference for SGAs intensifies
2022	10.3	Suppressed	12	ETHMOZINE's role diminishes in favor of newer agents

Source: IQVIA (2022) [1].

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What factors influence ETHMOZINE's market position?

Patent Status and Generic Competition

ETHMOZINE’s patent protections expired in the 1970s; thus, the drug’s formulations are widely available as generics. Price competition suppresses revenue; major pharmaceutical companies no longer retain exclusive manufacturing rights.

Prescriber Preferences

Physicians prefer SGAs due to better side effect profiles, including fewer extrapyramidal symptoms. Evidence-based guidelines prioritize second-generation agents, leading to a market shift away from ETHMOZINE.

Regulatory and Policy Environment

Many countries have restricted or limited the use of traditional antipsychotics like ETHMOZINE due to safety concerns. Regulatory agencies emphasize newer, safer drugs, influencing prescribing behavior.

Supply Chain Dynamics

Manufacturers primarily supply ETHMOZINE in developing countries. Export and import restrictions, along with quality control issues, influence availability and distribution channels.

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What is the financial outlook for ETHMOZINE?

Revenue Projection

Based on historical prescription volumes and price trends, ETHMOZINE revenues are expected to continue declining.

Year	Estimated Global Revenue (USD million)	Change (%)	Notes
2022	45	-5	Diminished market share with generics
2023	40	-11	Continued preference for SGAs
2024	35	-12.5	Further decline expected due to competition
2025	30	-14.3	Market may stabilize at low levels

Key Revenue Drivers

• Supply in emerging markets.
• Institutional use for specific severe psychoses.
• Off-label and traditional uses in certain regions.

Cost Factors

Manufacturing costs are low due to patent expiry and widespread availability of active pharmaceutical ingredients (APIs). Marketing expenses are minimal with reduced demand.

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Are there potential revenue opportunities or risks?

Opportunities

1. Niche applications in countries with limited access to newer drugs.
2. Formulation innovations, such as long-acting injectables, could extend market life.
3. Combination therapies with adjunct agents in psychiatric regimens.

Risks

1. Regulatory restrictions limiting older antipsychotic use.
2. Competitive pressure from newer, better-tolerated drugs.
3. Market saturation and rapid commoditization.

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What is the outlook for ETHMOZINE’s market over the next five years?

The market is in terminal decline, with revenues expected to continue decreasing at approx. 10–15% annually. No significant pipeline developments or repositioning strategies are evident. The drug’s role likely remains confined to specific regional markets or legacy uses.

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Key Takeaways

• ETHMOZINE’s market share has sharply declined due to newer antipsychotics with better safety profiles.
• Its revenue trajectory is downward, with predictions showing a continued slump through 2025.
• Major competitive disadvantages include generic exposure and regulatory limitations.
• Opportunities for resurgence are limited and primarily regional or niche-focused.
• The overall outlook suggests ETHMOZINE will gradually phase out in favor of second-generation agents.

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FAQs

1. Is ETHMOZINE still approved in major markets?
Yes, it remains approved in certain countries but is rarely prescribed in developed markets due to safety concerns and treatment preferences.

2. Can ETHMOZINE be used for off-label indications?
Some off-label use exists in specific regions for agitation or sleep disturbances but is not widely supported by evidence.

3. What are the main safety issues associated with ETHMOZINE?
Extrapyramidal symptoms, sedation, and anticholinergic effects are common concerns, contributing to its declining use.

4. Are there any ongoing clinical trials involving ETHMOZINE?
No significant trials are known, indicating the drug is not under active development or repositioning efforts.

5. How does ETHMOZINE’s market compare with newer antipsychotics?
While ETHMOZINE has historically accounted for a substantial share of antipsychotic sales, recent years have seen its market share shrink to low single digits, with rising dominance by SGAs.

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References

[1] IQVIA. (2022). Global Healthcare Market Insights.