Loxapine - Generic Drug Details

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

Loxapine is the generic ingredient in five branded drugs marketed by Alexza Pharms, Teva Branded Pharm, Actavis Labs Ut Inc, Elite Labs Inc, Lannett Co Inc, Rising, and Watson Labs, and is included in eleven NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Loxapine has twenty-one patent family members in six countries.

There are eight drug master file entries for loxapine. One supplier is listed for this compound.

Summary for loxapine

International Patents:	21
US Patents:	1
Tradenames:	5
Applicants:	7
NDAs:	11
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	25
Patent Applications:	6,704
Drug Prices:	Drug price trends for loxapine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for loxapine
What excipients (inactive ingredients) are in loxapine?	loxapine excipients list
DailyMed Link:	loxapine at DailyMed

See drug prices for loxapine

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for loxapine

Constraining patent/regulatory exclusivity:

8,387,612

Dosage:

POWDER;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for loxapine

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	Phase 3
Lariboisière-Saint Louis clinical research unit	Phase 3
Lee's Pharmaceutical Limited	Phase 3

See all loxapine clinical trials

Medical Subject Heading (MeSH) Categories for loxapine

Antipsychotic Agents

Dopamine Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for loxapine

N05AH	Diazepines, oxazepines, thiazepines and oxepines
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for loxapine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Rising	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076762-001	Nov 1, 2004		DISCN	No	No
Elite Labs Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076868-001	Aug 4, 2005	AB	RX	No	No
Watson Labs	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	072206-001	Jun 15, 1988	AB	RX	No	Yes
Elite Labs Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	076868-003	Aug 4, 2005	AB	RX	No	No
Lannett Co Inc	LOXAPINE SUCCINATE	loxapine succinate	CAPSULE;ORAL	090695-004	Sep 26, 2011	AB	RX	No	No

Expired US Patents for loxapine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	8,074,644
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	7,585,493
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	7,078,020
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	9,439,907
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	7,090,830
Alexza Pharms	ADASUVE	loxapine	POWDER;INHALATION	022549-001	Dec 21, 2012	6,716,416

EU/EMA Drug Approvals for loxapine

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Ferrer Internacional S.A.	Adasuve	loxapine	EMEA/H/C/002400 Adasuve is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder. Patients should receive regular treatment immediately after control of acute agitation symptoms.	Authorised	no	no	no	2013-02-20

International Patents for loxapine

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2004104490
European Patent Office	1625336	UTILISATION D'UNE COUCHE DE COMBUSTIBLE SOLIDE, PROCÉDÉ POUR FABRIQUER UNE TELLE COUCHE ET UNITÉ DE CHAUFFAGE CORRESPONDANTE (USE OF A LAYER OF SOLID FUEL, METHOD FOR PRODUCING SUCH A LAYER AND ASSOCIATED HEATING UNIT)
Canada	2526470	UNITE DE CHAUFFAGE AUTONOME ALLUMEE PAR PERCUSSION OU ALLUMEE ELECTRIQUEMENT ET UNITE DE DISTRIBUTION DE MEDICAMENTS FAISANT APPEL A CETTE DERNIERE (PERCUSSIVELY IGNITED OR ELECTRICALLY IGNITED SELF-CONTAINED HEATING UNIT AND DRUG-SUPPLY UNIT EMPLOYING SAME)
Japan	2007516015
Canada	2526478	PROCEDE DE REGULATION THERMIQUE UNIFORME D'UN SUBSTRAT ; UNITE DE CHAUFFAGE INTEGREE ET UNITE D'ADMINISTRATION DE MEDICAMENTS RECOURANT A CE PROCEDE (METHODS OF CONTROLLING UNIFORMITY OF SUBSTRATE TEMPERATURE AND SELF-CONTAINED HEATING UNIT AND DRUG-SUPPLY UNIT EMPLOYING SAME)
European Patent Office	1625335	UNITE DE CHAUFFAGE AUTONOME A ALLUMAGE OPTIQUE , ET UNITE D'ADMINISTRATION DE MEDICAMENT UTILISANT CETTE UNITE DE CHAUFFAGE (OPTICALLY IGNITED SELF-CONTAINED HEATING UNIT AND DRUG-SUPPLY UNIT EMPLOYING SAME)

Supplementary Protection Certificates for loxapine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1389098	SPC/GB13/055	United Kingdom		PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220
1389098	300609	Netherlands		PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220
1389098	2013C/054	Belgium		PRODUCT NAME: LOXAPINE; AUTHORISATION NUMBER AND DATE: EU/1/13/823/001 20130225
1389098	C300609	Netherlands		PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220

Market Dynamics and Financial Trajectory for Loxapine

Introduction

Loxapine, an antipsychotic medication, is used primarily to treat schizophrenia and other psychotic disorders. Understanding the market dynamics and financial trajectory of loxapine is crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Size and Growth

The global loxapine market is anticipated to grow at a compound annual growth rate (CAGR) of 3 to 5 percent from 2024 to 2031. The market size is estimated to reach a significant valuation by 2031, with the base year for calculations being 2023[4].

Segmentation

The loxapine market is segmented based on several key factors:

By Type

Loxapine is available in various forms, including powder and tablets. These forms cater to different patient needs and preferences, influencing market dynamics. The powder form is often used for patients who have difficulty swallowing tablets, while tablets are more commonly prescribed due to their ease of administration[4].

By Application

The primary applications of loxapine include hospitals and drug stores. Hospitals are a significant segment due to the need for controlled administration and monitoring of patients, especially those with severe psychiatric conditions. Drug stores also play a crucial role as they provide easy access to the medication for outpatient treatment[4].

By Geography

The market is geographically segmented into North America, Europe, Asia-Pacific, South America, and the Middle East & Africa. Each region has its own set of market drivers, restraints, and opportunities. For instance, the Asia-Pacific region is expected to show significant growth due to increasing healthcare expenditure and a large patient population[1][4].

Market Drivers

Several factors drive the growth of the loxapine market:

Increasing Prevalence of Psychiatric Disorders

The rising prevalence of schizophrenia and other psychotic disorders is a key driver. As the global population grows and mental health awareness increases, the demand for effective antipsychotic medications like loxapine is expected to rise[1].

Advancements in Healthcare Infrastructure

Improvements in healthcare infrastructure, particularly in developing regions, enhance the accessibility and affordability of psychiatric treatments. This expansion of healthcare services drives the demand for loxapine and other antipsychotic medications[1].

Government Initiatives and Funding

Government initiatives aimed at improving mental health services and increasing funding for psychiatric care also contribute to market growth. These initiatives often include programs for early diagnosis and treatment, which can increase the use of loxapine[3].

Market Restraints

Despite the growth drivers, there are several restraints that affect the loxapine market:

Side Effects and Safety Concerns

Loxapine is associated with several side effects, including extrapyramidal symptoms, dry mouth, and increased risk of infections due to lowered white blood cell counts. These side effects can limit its use and impact market growth[2].

Regulatory Challenges

Stringent regulatory requirements and the need for continuous monitoring of drug safety can pose challenges for manufacturers. Compliance with these regulations can be costly and time-consuming, affecting the market's financial trajectory[1].

Competition from Alternative Treatments

The presence of other antipsychotic medications and emerging therapies can compete with loxapine for market share. This competition may lead to pricing pressures and reduced market size for loxapine[4].

Financial Trajectory

The financial trajectory of the loxapine market is influenced by several factors:

Revenue Forecast

The global loxapine market is expected to generate significant revenue from 2024 to 2031, driven by the increasing demand for antipsychotic medications. The revenue growth is projected to be steady, with a CAGR of 3 to 5 percent[4].

Key Players and Market Share

Major pharmaceutical companies such as Watson Laboratories, Teva, Mylan Pharmaceuticals, and others play a significant role in the loxapine market. These companies invest heavily in research and development, marketing, and distribution, which affects the market's financial dynamics[4].

Regional Market Performance

The performance of the loxapine market varies by region. North America and Europe are mature markets with established healthcare systems, while the Asia-Pacific region is expected to show rapid growth due to its large population and increasing healthcare expenditure[1][4].

Technological and Therapeutic Trends

Delayed-Onset Hypothesis

Research on antipsychotic medications, including loxapine, suggests a delayed-onset hypothesis, where significant clinical improvement may take weeks to achieve. This understanding can influence treatment protocols and patient expectations, impacting market dynamics[5].

Patient Compliance and Monitoring

Advancements in patient compliance and monitoring technologies can improve the efficacy of loxapine treatment. Digital health solutions and telemedicine platforms are becoming more prevalent, enhancing the management of psychiatric disorders and potentially increasing the market size for loxapine[1].

Competitive Analysis

The loxapine market is competitive, with several key players vying for market share. Companies are focusing on improving their product offerings, expanding their distribution networks, and engaging in strategic partnerships to stay competitive.

SWOT Analysis

• Strengths: Established brand presence, extensive distribution networks, and ongoing research and development.
• Weaknesses: Side effects and safety concerns, regulatory challenges, and competition from alternative treatments.
• Opportunities: Growing demand for antipsychotic medications, advancements in healthcare infrastructure, and government initiatives.
• Threats: Pricing pressures, stringent regulatory requirements, and the emergence of new therapies[1].

Consumer Behavior Analysis

Consumer behavior plays a crucial role in the loxapine market. Patients and healthcare providers are increasingly seeking medications with fewer side effects and better efficacy. This shift in consumer behavior can influence the market's financial trajectory and drive innovation in antipsychotic treatments.

Patient Preferences

Patients prefer medications that are easy to administer and have minimal side effects. The availability of loxapine in both powder and tablet forms caters to these preferences, enhancing patient compliance and satisfaction[2].

Healthcare Provider Influence

Healthcare providers play a significant role in prescribing medications. Their preferences and recommendations can significantly impact the market share of loxapine. Continuous education and awareness campaigns about the benefits and risks of loxapine are essential for maintaining a strong market presence[1].

COVID-19 Impact

The COVID-19 pandemic has had a mixed impact on the loxapine market. On one hand, the pandemic has highlighted the importance of mental health services, potentially increasing the demand for antipsychotic medications. On the other hand, disruptions in supply chains and healthcare services have posed challenges for the market[1].

Key Takeaways

• The global loxapine market is expected to grow at a CAGR of 3 to 5 percent from 2024 to 2031.
• The market is segmented by type (powder, tablet), application (hospital, drug store), and geography.
• Increasing prevalence of psychiatric disorders, advancements in healthcare infrastructure, and government initiatives drive market growth.
• Side effects, regulatory challenges, and competition from alternative treatments are key restraints.
• The financial trajectory is influenced by revenue forecasts, key players, and regional market performance.

FAQs

What is the primary use of loxapine?

Loxapine is primarily used to treat schizophrenia and other psychotic disorders.

What are the common side effects of loxapine?

Common side effects include extrapyramidal symptoms, dry mouth, and increased risk of infections due to lowered white blood cell counts[2].

Which regions are expected to show significant growth in the loxapine market?

The Asia-Pacific region is expected to show rapid growth due to its large population and increasing healthcare expenditure[1][4].

How does the delayed-onset hypothesis affect the use of loxapine?

The delayed-onset hypothesis suggests that significant clinical improvement from loxapine may take weeks to achieve, influencing treatment protocols and patient expectations[5].

What are the key drivers of the loxapine market?

Key drivers include the increasing prevalence of psychiatric disorders, advancements in healthcare infrastructure, and government initiatives aimed at improving mental health services[1].

Sources

1. Cognitive Market Research: Global Loxapine Market Report 2024 Edition.
2. Mayo Clinic: Loxapine (oral route).
3. Interact for Health: FINAL REPORT Evaluation of Healthcare Costs and Utilization.
4. Market Research Intellect: Global Loxapine Market Size And Forecast.
5. JAMA Network: Delayed-Onset Hypothesis of Antipsychotic Action.