LOXITANE C Drug Patent Profile

Which patents cover Loxitane C, and what generic alternatives are available?

Loxitane C is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in LOXITANE C 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 C

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	13
Clinical Trials:	1
Patent Applications:	388
DailyMed Link:	LOXITANE C at DailyMed

Recent Clinical Trials for LOXITANE C

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

Sponsor	Phase
Mylan Pharmaceuticals	Phase 1

See all LOXITANE C clinical trials

US Patents and Regulatory Information for LOXITANE C

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 C	loxapine hydrochloride	CONCENTRATE;ORAL	017658-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for LOXITANE C

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	LOXITANE C	loxapine hydrochloride	CONCENTRATE;ORAL	017658-001	Approved Prior to Jan 1, 1982	3,546,226
Teva Branded Pharm	LOXITANE C	loxapine hydrochloride	CONCENTRATE;ORAL	017658-001	Approved Prior to Jan 1, 1982	4,049,809

International Patents for LOXITANE C

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

Country	Patent Number	Title	Estimated Expiration
Switzerland	436297	Verfahren zur Herstellung 11-basisch substituierter Dibenz(b, f)-(1,4)oxazepine
Brazil	6457122
Austria	292707
Switzerland	481940	Verfahren zur Herstellung basisch substituierter Heterocyclen
Belgium	712114

Supplementary Protection Certificates for LOXITANE C

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	C300609	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	300609	Netherlands		PRODUCT NAME: LOXAPINE; REGISTRATION NO/DATE: EU/1/13/823/001-002 20130220

LOXITANE C Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LOXITANE C (Loxapine)

Overview of LOXITANE C

LOXITANE C, also known as Loxapine, is a dibenzoxazepine compound used primarily in the treatment of schizophrenia and agitation associated with psychotic disorders. It is a dopamine antagonist and a serotonin 5-HT2 blocker, belonging to a subclass of tricyclic antipsychotic agents[4].

Historical Approval and Usage

Loxapine was first approved for marketing in the European Union in the 1970s and has since been approved in various regions including the US and Canada. It is available in multiple formulations such as oral capsules, oral concentrate, and intramuscular injections[1][2].

Indications and Usage

LOXITANE C is indicated for the treatment of schizophrenia, with efficacy established in clinical studies involving both newly hospitalized and chronically hospitalized patients. It is also used for the rapid control of agitation in adult patients with schizophrenia or bipolar disorder[1][2].

Market Position

Competitive Landscape

The antipsychotic market is highly competitive, with several other drugs such as olanzapine, quetiapine, risperidone, and ziprasidone. However, Loxapine's unique pharmacological profile, which includes its antagonism of dopamine D2 receptors and serotonin 5-HT2A receptors, as well as its anti-cholinergic, anti-histaminergic, and anti-alpha-adrenergic properties, sets it apart from other antipsychotics[1][4].

Market Share

While specific market share data for LOXITANE C is not readily available, it is known that the drug has a niche position in the antipsychotic market. Its use is often reserved for patients who do not respond well to other antipsychotic medications or who require rapid control of agitation.

Financial Trajectory

Pricing and Cost

The pricing of LOXITANE C varies by formulation and region. For example, in the US, the cost of Loxapine capsules can range from approximately $1.58 per 5 mg capsule to $4.04 per 50 mg capsule. Generic versions, such as those from Apotex Corporation and Dominion Pharmacal, are also available at lower prices, further influencing the financial dynamics[4].

Revenue Trends

The revenue generated by LOXITANE C is influenced by several factors, including prescription rates, competition from other antipsychotics, and the availability of generic versions. While the drug has been on the market for several decades, its revenue has likely been impacted by the introduction of newer antipsychotic medications.

Impact of Generic Competition

The availability of generic versions of Loxapine has significantly impacted its financial trajectory. Generic competition has led to a reduction in prices, making the drug more accessible but also reducing the revenue for the original manufacturer. This is evident from the pricing data, where generic versions are often 50% or more cheaper than the branded versions[4].

Regulatory and Safety Considerations

Safety Profile

LOXITANE C has a complex safety profile, with several significant adverse effects. These include increased mortality in elderly patients with dementia-related psychosis, hematologic effects such as agranulocytosis and leukopenia, cardiovascular effects, and anticholinergic effects. These safety concerns can impact prescribing rates and, consequently, the financial performance of the drug[2].

Regulatory Approvals and Updates

The drug has undergone various regulatory reviews and updates. For instance, the stability data and manufacturing process for ADASUVE, an inhalable form of Loxapine, have been extensively validated to ensure compliance with proposed release specifications[1].

Market Growth and Projections

Current Market Size

The current market size for antipsychotic medications is substantial, driven by the prevalence of schizophrenia and other psychotic disorders. However, the specific market size for LOXITANE C is smaller compared to more widely prescribed antipsychotics.

Future Projections

The future growth of LOXITANE C is likely to be modest, influenced by the ongoing competition from newer antipsychotic medications and the continued availability of generic versions. Any significant growth would likely come from niche applications or new indications that could be approved through further clinical trials.

Key Takeaways

• Unique Pharmacological Profile: LOXITANE C's distinct mechanism of action sets it apart in the antipsychotic market.
• Competitive Landscape: The drug faces competition from a range of other antipsychotics, including newer medications.
• Pricing and Cost: The availability of generic versions has reduced the cost and impacted revenue.
• Safety Profile: Significant adverse effects influence prescribing rates and financial performance.
• Regulatory Considerations: Ongoing regulatory reviews and stability data validation are crucial for market presence.

FAQs

What is LOXITANE C used for?

LOXITANE C is used for the treatment of schizophrenia and the rapid control of agitation in adult patients with schizophrenia or bipolar disorder.

What are the common side effects of LOXITANE C?

Common side effects include anticholinergic effects, cardiovascular effects, hematologic effects such as agranulocytosis and leukopenia, and increased mortality in elderly patients with dementia-related psychosis.

Is LOXITANE C available in generic form?

Yes, LOXITANE C is available in generic form, which has significantly reduced its cost and impacted its revenue.

How does LOXITANE C compare to other antipsychotics?

LOXITANE C has a unique pharmacological profile, including dopamine D2 receptor and serotonin 5-HT2A receptor antagonism, setting it apart from other antipsychotics.

What are the regulatory considerations for LOXITANE C?

The drug has undergone extensive regulatory reviews, including stability data validation and manufacturing process approvals, to ensure compliance with proposed release specifications.

Sources

1. European Medicines Agency: Adasuve, INN-loxapine - European Medicines Agency.
2. FDA: Loxapine Succinate USP Capsules LOXITANE - accessdata.fda.gov.
3. Google Patents: EP2665478A1 - Treatment of cognitive dysfunction in schizophrenia.
4. DrugBank: Loxapine: Uses, Interactions, Mechanism of Action | DrugBank Online.