Haloperidol - Generic Drug Details

What are the generic drug sources for haloperidol and what is the scope of freedom to operate?

Haloperidol is the generic ingredient in six branded drugs marketed by Ortho Mcneil, Ortho Mcneil Pharm, Actavis Group, Aiping Pharm Inc, Appco, Aurobindo Pharma Ltd, Chartwell Rx, Creekwood Pharms, Duramed Pharms Barr, Innogenix, Lederle, Mankind Pharma, MSN, Mylan, Par Pharm, Purepac Pharm, Quantum Pharmics, Royce Labs, SCS, Strides Pharma Intl, Watson Labs, Zydus Pharms Usa, Janssen Pharms, Caplin, Fresenius Kabi Usa, Gland, Hikma, Hospira, Meitheal, Mylan Labs Ltd, Sandoz, Somerset Theraps Llc, Teva Pharms Usa, Zydus Pharms, Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon Research, Teva, Teva Pharms, Abraxis Pharm, Baxter Hlthcare Corp, Epic Pharma Llc, Fosun Pharma, Gland Pharma Ltd, Marsam Pharms Llc, Sagent Pharms, Smith And Nephew, Solopak, and Actavis Mid Atlantic, and is included in one hundred and fourteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for haloperidol

US Patents:	0
Tradenames:	6
Applicants:	51
NDAs:	114
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	236
Patent Applications:	6,790
Drug Prices:	Drug price trends for haloperidol
What excipients (inactive ingredients) are in haloperidol?	haloperidol excipients list
DailyMed Link:	haloperidol at DailyMed

See drug prices for haloperidol

See drug sales revenues for haloperidol

Recent Clinical Trials for haloperidol

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

Sponsor	Phase
Montefiore Medical Center	PHASE4
University Hospital, Strasbourg, France	PHASE2
Mercy Bon Secours Saint Vincent Medical Center	PHASE3

See all haloperidol clinical trials

Pharmacology for haloperidol

Drug Class

Typical Antipsychotic

Medical Subject Heading (MeSH) Categories for haloperidol

Anti-Dyskinesia Agents

Antiemetics

Antipsychotic Agents

Dopamine Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for haloperidol

N05AD	Butyrophenone derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for haloperidol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa	HALOPERIDOL DECANOATE	haloperidol decanoate	INJECTABLE;INJECTION	075393-002	May 11, 1999		DISCN	No	No
Royce Labs	HALOPERIDOL	haloperidol	TABLET;ORAL	072121-001	Dec 24, 1987		DISCN	No	No
Creekwood Pharms	HALOPERIDOL	haloperidol	TABLET;ORAL	218162-004	Dec 18, 2025	AB	RX	No	No

Expired US Patents for haloperidol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-001	Approved Prior to Jan 1, 1982	3,438,991
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-006	Feb 2, 1982	3,438,991
Ortho Mcneil	HALDOL	haloperidol	TABLET;ORAL	015921-002	Approved Prior to Jan 1, 1982	3,438,991

Market Dynamics and Financial Trajectory for Haloperidol

Last updated: February 19, 2026

What are the current market factors influencing haloperidol?

Haloperidol remains a heavily used antipsychotic medication, primarily for schizophrenia, acute psychosis, and Tourette syndrome management. The drug's market is shaped by several key factors:

• Patent Status: Generic versions dominate, leading to pricing pressures. No recent patent protections are active since the original patent expired in the 1980s.
• Manufacturing & Supply: Multiple pharmaceutical companies produce haloperidol, ensuring supply stability but also intense price competition.
• Regulatory Environment: Approvals are well established globally, with no significant barriers to generic manufacturing.
• Demand Drivers: Rising prevalence of schizophrenia and neuropsychiatric conditions, especially in aging populations, sustains consistent demand.
• Reimbursement & Pricing: Insurance coverage varies across regions but generally favors cost-effective generics, affecting profitability.

How does the competitive landscape impact haloperidol’s market share?

The global antipsychotics market includes both atypical and typical antipsychotics. Haloperidol, classified as a typical antipsychotic, faces competition from:

• Atypical Antipsychotics: Drugs like risperidone, olanzapine, and quetiapine, which offer improved side-effect profiles.
• Market Share: Despite the competition, haloperidol maintains a significant portion of the market due to cost advantages and clinical familiarity.
• Pricing Trends: Generic versions are priced lower than newer atypicals, limiting revenue potential for individual manufacturers.

What are the recent financial trends for haloperidol manufacturers?

Data analysis suggests:

Year	Revenue from Haloperidol (Est.)	Major Manufacturers	Notes
2018	~$500 million	Multiple Generics	Dominant source of income, competitive pricing
2020	~$480 million	Multiple Generics	Slight decline due to market saturation
2022	~$470 million	Multiple Generics	Slight downward trend continues

Profit margins are slim due to high competition and low drug prices. Companies mainly generate revenue via volume rather than premium pricing.

What are the future growth prospects?

• Market Penetration: Expected to remain stable or marginally decline due to the shift toward atypical antipsychotics.
• Therapeutic Alternatives: Increasing adoption of newer drugs with better side-effect profiles may reduce demand.
• Regulatory Changes: Tightened regulations on off-label use or new safety warnings could impact supply and sales.
• Global Expansion: Emerging markets present growth opportunities, as access to affordable antipsychotics remains a priority.

How do patent expirations influence the financial trajectory?

The original patent for haloperidol expired decades ago, leading to the proliferation of generics. This has diminished potential revenue streams, although volume-based sales sustain manufacturers' profits. No new formulations or patents are likely in the foreseeable future.

What are the risks affecting the market trajectory?

• Market Saturation: High availability of generics constrains profit margins.
• Regulatory Risks: Changes in approval standards or safety regulations could lead to market withdrawals.
• Therapeutic Shift: Preference for atypical antipsychotics impacts demand.
• Pricing Pressure: Increasing healthcare cost containment measures put further downward pressure on prices.

Key Takeaways

• Haloperidol’s global market remains sizable but is declining in value, primarily due to the rise of atypical antipsychotics and generic competition.
• Revenue streams are volume-driven with slim margins given competitive pricing.
• Future growth depends on geographic expansion, regulatory stability, and investment in formulations with improved safety profiles.
• Market risks include regulatory changes, therapeutic preferences, and consolidation among generic manufacturers.

FAQs

1. How does haloperidol’s patent status affect its market?
Since patents expired decades ago, generic manufacturers produce it widely, leading to low prices and intense competition.

2. Are clinical safety issues impacting market demand?
Yes, concerns over extrapyramidal side effects and tardive dyskinesia have led some prescribers to prefer atypical antipsychotics, impacting overall demand.

3. What regions offer the most growth potential?
Emerging markets in Asia and Latin America represent opportunities due to increased access to affordable medications.

4. Are new formulations in development?
No significant new formulations or patents are in the pipeline; focus remains on existing generics.

5. How does the shift to atypical antipsychotics influence future revenue?
It undermines the long-term revenue of haloperidol, as clinicians prefer newer drugs with fewer side effects, decreasing market share.

---

References

[1] European Medicines Agency. (2021). Historical review of haloperidol.
[2] IQVIA. (2022). Global antipsychotics market analysis.
[3] U.S. Food and Drug Administration. (2020). Generic drug approvals.
[4] World Health Organization. (2021). Global overview of schizophrenia treatments.
[5] Pharma Intelligence. (2022). Market trends for antipsychotics.