LOXITANE Drug Patent Profile

Which patents cover Loxitane, and when can generic versions of Loxitane launch?

Loxitane is a drug marketed by Teva Branded Pharm and Actavis Labs Ut Inc and is included in three NDAs.

The generic ingredient in LOXITANE is loxapine hydrochloride. There are eight drug master file entries for this compound. Additional details are available on the loxapine hydrochloride profile page.

Summary for LOXITANE

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	51
Clinical Trials:	1
Patent Applications:	5,094
DailyMed Link:	LOXITANE at DailyMed

Recent Clinical Trials for LOXITANE

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1

See all LOXITANE clinical trials

US Patents and Regulatory Information for LOXITANE

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	017525-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva Branded Pharm	LOXITANE	loxapine succinate	TABLET;ORAL	017525-008	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-004	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva Branded Pharm	LOXITANE C	loxapine hydrochloride	CONCENTRATE;ORAL	017658-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-003	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Teva Branded Pharm	LOXITANE	loxapine succinate	TABLET;ORAL	017525-007	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for LOXITANE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-001	Approved Prior to Jan 1, 1982
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-004	Approved Prior to Jan 1, 1982
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-002	Approved Prior to Jan 1, 1982
Teva Branded Pharm	LOXITANE	loxapine succinate	CAPSULE;ORAL	017525-003	Approved Prior to Jan 1, 1982

International Patents for LOXITANE

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

Country	Patent Number	Title	Estimated Expiration
Austria	292717
Belgium	712114
Switzerland	450426	Verfahren zur Herstellung 11-basisch substituierter Dibenz(b,f)(1,4)oxazepine
Switzerland	485765	Verfahren zur Herstellung basisch substituierter Heterocyclen
Brazil	6457122
Switzerland	485752	Verfahren zur Herstellung basisch substituierter Heterocyclen
Switzerland	485749	Verfahren zur Herstellung basisch substituierter Heterocyclen

Supplementary Protection Certificates for LOXITANE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1389098	SPC/GB13/055	United Kingdom		PRODUCT NAME: LOXAPINE; REGISTERED: UK EU/1/13/823/001 20130220; UK EU/1/13/823/002 20130220

LOXITANE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Loxitane (Loxapine)

Introduction to Loxitane

Loxitane, also known by its generic name loxapine, is an antipsychotic medication used primarily to treat schizophrenia and other psychotic disorders. It belongs to the class of first-generation antipsychotics.

Market Overview of Antipsychotic Drugs

The global antipsychotic drugs market is expected to grow at a CAGR of around 2.5% from 2017 to 2025, reaching approximately $14.91 billion by 2025[1].

Growing Incidence of Mental Health Disorders

The increasing incidence of mental health disorders such as schizophrenia, bipolar disorders, and dementia drives the demand for antipsychotic drugs. This trend is a significant factor in the growth of the market.

Technological Innovations

Recent technological developments in antipsychotic drugs, including the introduction of new formulations and delivery methods, have improved the efficacy and patient compliance of these medications. For example, the development of injectable forms like Loxapac (loxapine intramuscular injection) has enhanced treatment options for patients with schizophrenia[4].

Market Segmentation

By Application

Loxitane is primarily used for treating schizophrenia but can also be prescribed for other conditions such as bipolar disorders and severe depression.

• Schizophrenia: This is the primary indication for Loxitane, and it remains a significant segment within the antipsychotic market.
• Other Applications: While less common, Loxitane may be used off-label for other psychiatric conditions, contributing to its market presence.

By Class Type

Loxitane falls under the category of first-generation antipsychotics.

• First Generation: This class includes other drugs like Haldo (Haloperidol), Trilafon (Perphenazine), and Thorazine (Chlorpromazine HCl). First-generation antipsychotics are known for their efficacy but also for their side effects, which can impact market dynamics[1].

Financial Trajectory

Revenue and Growth

The antipsychotic drugs market, which includes Loxitane, is expected to see steady growth driven by increasing demand and technological advancements. However, the specific financial trajectory of Loxitane can be influenced by several factors:

• Competition: The presence of second and third-generation antipsychotics, which often have fewer side effects, can impact the market share of first-generation drugs like Loxitane.
• Patent Expiries: The loss of patent exclusivity for branded antipsychotic drugs can lead to increased competition from generics, affecting revenue. For instance, the patent expiry of drugs like Zyprexa (Olanzapine) and Seroquel (Quetiapine) has led to significant changes in market dynamics[3].

Pricing and Spending Trends

• Price Increases: Protected brand price increases have contributed significantly to the growth in spending on antipsychotic drugs. However, these increases are often offset by rebates and discounts, which can affect the net price growth[3].
• Generic Competition: The availability of generic versions of antipsychotic drugs can reduce spending on branded products like Loxitane. For example, the generic version of loxapine can offer a cost-effective alternative, impacting the financial performance of the branded product.

Supply Chain and Manufacturing

• Shortages: Manufacturing disruptions can lead to shortages, as seen with Loxapac (loxapine intramuscular injection) in Canada, which is expected to end by September 2024. Such shortages can temporarily affect revenue and market availability[4].

Key Players and Market Activities

Major pharmaceutical companies such as Bristol-Myers Squibb Company, Pfizer, Inc., Glaxo SmithKline, Plc, and Eli Lilly & Co. are key players in the antipsychotic drugs market. These companies invest heavily in research and development, marketing, and distribution, which can influence the market dynamics of specific drugs like Loxitane[1].

Regional Market Analysis

The antipsychotic drugs market is analyzed on a global as well as regional level. Different regions have varying demand patterns and regulatory environments that can impact the sales and revenue of Loxitane.

Challenges and Opportunities

Challenges

• Side Effects: First-generation antipsychotics like Loxitane are known for their side effects, which can lead to patient non-compliance and reduced market share.
• Generic Competition: The availability of generic alternatives can reduce the market share and revenue of branded products.

Opportunities

• Technological Innovations: Improvements in drug formulations and delivery methods can enhance patient compliance and treatment outcomes.
• Growing Demand: The increasing incidence of mental health disorders presents a growing market opportunity for antipsychotic drugs.

Regulatory Environment

Regulatory changes and approvals can significantly impact the market dynamics of antipsychotic drugs. For instance, the approval of new formulations or the extension of patent exclusivity can affect the financial trajectory of Loxitane.

Conclusion

The market dynamics and financial trajectory of Loxitane are influenced by a combination of factors including the growing incidence of mental health disorders, technological innovations, competition from newer generations of antipsychotics, and regulatory environments. While Loxitane remains a significant player in the antipsychotic market, its financial performance is subject to various challenges and opportunities.

Key Takeaways

• Growing Demand: Increasing incidence of mental health disorders drives the demand for antipsychotic drugs.
• Technological Innovations: New formulations and delivery methods enhance treatment options and patient compliance.
• Competition: Second and third-generation antipsychotics and generic alternatives impact the market share of first-generation drugs like Loxitane.
• Regulatory Environment: Changes in regulations and approvals can significantly affect the market dynamics.
• Supply Chain: Manufacturing disruptions and shortages can temporarily impact revenue and market availability.

FAQs

Q: What is Loxitane primarily used for?

A: Loxitane is primarily used to treat schizophrenia and other psychotic disorders.

Q: How does the global antipsychotic drugs market expect to grow?

A: The global antipsychotic drugs market is expected to grow at a CAGR of around 2.5% from 2017 to 2025, reaching approximately $14.91 billion by 2025.

Q: What are the main challenges faced by Loxitane in the market?

A: The main challenges include side effects, competition from newer generations of antipsychotics, and generic competition.

Q: How do technological innovations impact Loxitane?

A: Technological innovations, such as new formulations and delivery methods, can enhance patient compliance and treatment outcomes for Loxitane.

Q: What is the current status of Loxapac (loxapine intramuscular injection) in Canada?

A: There is a reported shortage of Loxapac in Canada due to a manufacturing disruption, which is expected to end by September 2024[4].

Sources

1. Research and Markets, "Global Antipsychotic Drugs Market Analysis & Trends - Industry Forecast to 2025"[1].
2. L'OCCITANE Group, "Annual Report - L'OCCITANE Group"[2].
3. IMS Institute for Healthcare Informatics, "Medicines Use and Spending Shifts"[3].
4. Health Canada, "Shortage of Loxapac (loxapine) intramuscular 50 mg/mL injection in Canada"[4].