Haloperidol lactate - Generic Drug Details

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

Haloperidol lactate is the generic ingredient in four branded drugs marketed by Ortho Mcneil, Alpharma, Lannett Co Inc, Morton Grove, Pharm Assoc, Rubicon, SCS, Teva, Teva Pharms, Hikma, Janssen Pharms, Abraxis Pharm, Baxter Hlthcare Corp, Epic Pharma Llc, Fosun Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Marsam Pharms Llc, Mylan Labs Ltd, Sagent Pharms, Smith And Nephew, Solopak, Teva Pharms Usa, Watson Labs, and Actavis Mid Atlantic, and is included in thirty-four NDAs. Additional information is available in the individual branded drug profile pages.

Thirteen suppliers are listed for this compound.

Summary for haloperidol lactate

US Patents:	0
Tradenames:	4
Applicants:	25
NDAs:	34
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	5
Patent Applications:	297
What excipients (inactive ingredients) are in haloperidol lactate?	haloperidol lactate excipients list
DailyMed Link:	haloperidol lactate at DailyMed

See drug sales revenues for haloperidol lactate

Recent Clinical Trials for haloperidol lactate

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

Sponsor	Phase
Christian Hassager	Phase 3
Services Institute of Medical Sciences, Pakistan	Phase 1
University Hospital, Basel, Switzerland	Phase 4

See all haloperidol lactate clinical trials

Pharmacology for haloperidol lactate

Drug Class

Typical Antipsychotic

Anatomical Therapeutic Chemical (ATC) Classes for haloperidol lactate

N05AD	Butyrophenone derivatives
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for haloperidol lactate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Epic Pharma Llc	HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	204849-001	Sep 6, 2017		DISCN	No	No
Baxter Hlthcare Corp	HALOPERIDOL	haloperidol lactate	INJECTABLE;INJECTION	076828-001	Aug 25, 2004		DISCN	No	No
Morton Grove	HALOPERIDOL	haloperidol lactate	CONCENTRATE;ORAL	070710-001	Mar 7, 1986		DISCN	No	No

Expired US Patents for haloperidol lactate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ortho Mcneil	HALDOL	haloperidol lactate	CONCENTRATE;ORAL	015922-001	Approved Prior to Jan 1, 1982	3,438,991
Janssen Pharms	HALDOL	haloperidol lactate	INJECTABLE;INJECTION	015923-001	Approved Prior to Jan 1, 1982	3,438,991

Haloperidol lactate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Haloperidol Lactate

Introduction

Haloperidol lactate, a high-potency first-generation antipsychotic, is one of the most frequently used antipsychotic medications worldwide. This article delves into the market dynamics and financial trajectory of haloperidol lactate, exploring its indications, market competition, pricing, and the financial implications of its development and sales.

Indications and Uses

Haloperidol lactate is indicated for the treatment of various psychotic disorders, including schizophrenia, acute psychosis, and Tourette syndrome. It is also used off-label for managing chorea associated with Huntington's disease and treating intractable hiccups[4].

Market Competition

The market for haloperidol lactate is characterized by multiple manufacturers, which can impact pricing and availability. Companies such as Janssen, Fresenius Kabi, Mylan Institutional, Patriot Pharmaceuticals, Sagent, and West-Ward produce haloperidol lactate injections, each with different formulations and packaging[1].

Product Availability

Despite the presence of multiple manufacturers, there have been instances of drug shortages. For example, Sagent discontinued haloperidol 5 mg/mL 10 mL vials but planned to relaunch the product. Teva is not currently marketing haloperidol lactate, while other companies like West-Ward and Fresenius Kabi continue to have the product available[1].

Pricing and Cost Considerations

The pricing of haloperidol lactate can vary based on the manufacturer, formulation, and region. Generally, generic versions of the drug tend to be more affordable compared to branded versions like Janssen's Haldol.

Cost of Production

The cost of producing haloperidol lactate is influenced by several factors, including raw material costs, manufacturing processes, and regulatory compliance. The overall cost of bringing a new drug to market, including haloperidol lactate, can be estimated to be around $1 billion for a new chemical entity (NCE), with significant portions of this cost attributed to failures and the elimination of unsuccessful compounds[3].

Financial Trajectory

Development Costs

The development of haloperidol lactate, like other pharmaceuticals, involves substantial investment in research, clinical trials, and regulatory approvals. The high attrition rates in drug development, particularly due to safety issues and lack of efficacy, add to the financial burden. Only about 20 new drugs are approved annually, down from 40 or 50 a decade ago, despite increased R&D investment[3].

Revenue and Profitability

Successful drugs like haloperidol lactate can generate significant revenue. However, the financial success of a drug is heavily influenced by its timing to market, competition, and patent life. A delay of six months in bringing a product to market can result in missing out on one-third of the potential profit over the product’s lifetime[3].

Market Share and Competition

Haloperidol lactate competes in a crowded market with other antipsychotic medications. The first-to-market advantage and the ability to capture market share quickly are crucial. Companies that are first to market often dictate the market price and capture a larger share of the market, which can significantly impact profitability[3].

Regulatory Environment

The regulatory environment plays a critical role in the financial trajectory of haloperidol lactate. Regulatory bodies demand more data on efficacy and side effects, which can increase development costs and time. However, successful navigation of these regulatory hurdles can lead to significant financial rewards[3].

Side Effects and Safety Profile

The safety profile of haloperidol lactate, including its side effects such as elevated prolactin levels, liver effects, and dermatologic reactions, can impact its market dynamics. Adverse effects can lead to reduced usage and increased regulatory scrutiny, affecting sales and profitability[2].

Patient and Market Demand

The demand for haloperidol lactate is driven by the prevalence of psychotic disorders and the need for effective treatments. The drug's efficacy in managing symptoms of schizophrenia and other conditions ensures a steady demand, which is a positive factor in its financial trajectory.

Generic vs. Branded Market

The availability of generic versions of haloperidol lactate can reduce the market share of branded products. Generic drugs are often cheaper, making them more accessible to a wider patient population. This competition can impact the pricing and profitability of branded versions[1].

International Market

Haloperidol lactate is used globally, and its market dynamics can vary significantly across different regions. Regulatory approvals, pricing regulations, and local competition all play a role in determining the drug's financial performance in international markets.

Conclusion

Haloperidol lactate operates within a complex market influenced by multiple factors including competition, regulatory environment, and patient demand. While it is a highly effective and widely used antipsychotic, its financial trajectory is shaped by the costs of development, regulatory approvals, and market competition.

Key Takeaways

• Market Competition: Multiple manufacturers produce haloperidol lactate, affecting pricing and availability.
• Pricing and Cost: Generic versions are generally more affordable; development costs are high due to regulatory and safety requirements.
• Financial Trajectory: Timely market entry and capturing market share are crucial for profitability; regulatory environment and safety profile impact financial success.
• Demand and Usage: Steady demand driven by the prevalence of psychotic disorders.
• Generic vs. Branded: Generic versions reduce the market share of branded products.

FAQs

Q: What are the primary indications for haloperidol lactate?

A: Haloperidol lactate is primarily indicated for the treatment of schizophrenia, acute psychosis, Tourette syndrome, and other severe behavioral states[4].

Q: How does the regulatory environment impact the financial trajectory of haloperidol lactate?

A: The regulatory environment demands more data on efficacy and side effects, increasing development costs and time. However, successful navigation of these regulations can lead to significant financial rewards[3].

Q: What are the main side effects of haloperidol lactate?

A: Side effects include elevated prolactin levels, liver effects, dermatologic reactions, and various other systemic effects[2].

Q: How does the availability of generic versions affect the market for haloperidol lactate?

A: Generic versions reduce the market share of branded products by offering cheaper alternatives, making the drug more accessible to a wider patient population[1].

Q: What is the estimated cost of bringing a new drug like haloperidol lactate to market?

A: The estimated cost is around $1 billion for a new chemical entity (NCE), with significant portions attributed to failures and the elimination of unsuccessful compounds[3].

Sources

1. ASHP: Drug Shortage Detail: Haloperidol Lactate Injection.
2. FDA: HALDOL (haloperidol) Label.
3. Informa Healthcare: Pharmaceutical Preformulation and Formulation.
4. DrugBank: Haloperidol: Uses, Interactions, Mechanism of Action.
5. NCBI: Haloperidol - Drugs and Lactation Database (LactMed®).