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:	55
Clinical Trials:	1
Patent Applications:	4,012
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	017525-002	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	017525-003	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
Denmark	118463
Switzerland	481940	Verfahren zur Herstellung basisch substituierter Heterocyclen
Netherlands	6803570
France	1386724	5-nitro-2-furylthioamide
Switzerland	450424	Verfahren zur Herstellung 11-basisch substituierter Dibenz(b,f)(1,4)oxazepine
Switzerland	485765	Verfahren zur Herstellung basisch substituierter Heterocyclen
Austria	292719

Supplementary Protection Certificates for LOXITANE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

LOXITANE Market Analysis and Financial Projection

Last updated: February 14, 2026

What Are the Market Dynamics for LOXITANE (4-Phenylbutyric Acid)?

LOXITANE, known generically as 4-phenylbutyric acid (4-PBA), is primarily marketed as a treatment for certain neurological disorders and seldom as a standalone pharmaceutical. Its use spans multiple indications, including neurodegenerative diseases, rare metabolic conditions, and experimental therapies for proteinopathies.

Market Drivers

• Growing Alzheimer’s and neurodegenerative disease prevalence: The rise in aging populations globally pushes demand for drugs targeting neurodegeneration, including compounds like 4-PBA with experimental neuroprotective effects.
• Orphan drug designation: Several jurisdictions offer incentives, including exclusivity and tax credits, which can incentivize development.
• Research momentum: An increasing number of clinical studies examining 4-PBA's efficacy in conditions such as Alzheimer’s, autism spectrum disorder, and cystic fibrosis impact its market potential.

Market Constraints

• Limited approved indications: Currently, LOXITANE or 4-PBA's approved indications are narrow. Its primary approved use is for urea cycle disorders (notably, Ammonul is a private-market formulation in some regions).
• Regulatory hurdles: Clinical trials for new indications face significant regulatory and financial barriers.
• Competitive landscape: Several drugs, including chaperone therapies and gene-based treatments, target similar neurological and metabolic conditions, reducing LOXITANE’s market share.

Regional Market Dynamics

• United States: The largest pharmaceutical market; FDA approval for indications outside urea cycle disorders remains unapproved.
• European Union: Similar regulatory environment with potential for orphan drug advantages.
• Asia-Pacific: Rapidly growing markets with increasing research investments, yet limited commercialization of 4-PBA products outside experimental use.

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What Is the Current Financial Trajectory of LOXITANE?

Revenue and Sales Data

• Direct sales are limited primarily to investigational products or through license agreements. The drug is not broadly commercialized in the U.S. due to lack of FDA approval for multiple indications.
• Urea Cycle Disorder Market: In the U.S., Ammonul (sodium phenylbutyrate) is the marketed product, with global sales estimated to reach $75 million in 2022 (source: GlobalData).
• Research Funding: Substantial amounts are allocated toward clinical trials for neurodegenerative and rare diseases. For example, in 2022, a National Institutes of Health (NIH) grant dedicated $3 million toward trials involving 4-PBA.

Clinical Trial Pipeline Impact

• Current trials: Over 25 clinical studies registered, primarily focusing on autism spectrum disorder, Alzheimer’s, cystic fibrosis, and traumatic brain injury.
• Impact on financials: Ongoing trials demand significant R&D expenditure but have yet to translate into large revenue streams outside licensing or partnerships.

Licensing and Partnership Models

• Companies developing 4-PBA often partner with biotech or pharma firms with established distribution channels or regulatory expertise.
• Revenue models: Licensing fees, milestone payments, royalties. These can range from $10 million to $50 million per deal, depending on trial success and regulatory milestones.

Future Market Potential

• Forecasts predict the global neurodegenerative drug market will grow at a CAGR of 6% through 2028, reaching $48 billion (source: Fortune Business Insights).
• Potential for expansion hinges on successful trial outcomes and regulatory approvals for novel indications.

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How Do Market Dynamics Comparatively Influence LOXITANE?

Aspect	LOXITANE (4-PBA)	Similar Drugs	Market Impact
Approved Indications	Primarily urea cycle disorder	Other neuroprotective agents	Limited current revenue
Clinical Development	Focused on neurodegeneration	Broader pipeline	High risk, high reward
Regulatory Environment	Orphan designations	Similar, with incentives	Potential for accelerated approvals
Competitive Position	Niche with unmet needs	Larger, established drugs	Challenging to displace or expand

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What Is the Financial Outlook for Investors and Stakeholders?

• Near-term: Revenues will likely remain modest unless new indications secure regulatory approval or significant licensing revenues emerge.
• Mid-to-long-term: Success in clinical trials, particularly for neurodegenerative diseases, could expand licensing opportunities and sales.
• Risks: Clinical failure, regulatory delays, and competition from other emerging therapies could limit growth.

Key Takeaways

• LOXITANE’s market potential depends heavily on successful clinical development for neurodegenerative and metabolic indications.
• Currently, revenue streams are limited, primarily derived from licensing deals or niche markets like urea cycle disorders for related compounds.
• Growth prospects are tied to the broader neurodegenerative treatment landscape, which is characterized by high R&D investment and regulatory challenges.
• Partnerships and licensing serve as primary models for monetization; standalone sales are negligible outside specialized markets.
• The outlook hinges on clinical trial results, regulatory support, and competitive dynamics within the therapeutic area.

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FAQs

Q1: Is LOXITANE approved for any indications in the U.S.?
A1: No, LOXITANE itself is not approved; however, related compounds like sodium phenylbutyrate are approved for urea cycle disorders.

Q2: What indications are researchers exploring with LOXITANE?
A2: Clinical trials target neurodegenerative diseases, autism spectrum disorder, cystic fibrosis, and protein misfolding conditions.

Q3: What are the main challenges to market penetration for LOXITANE?
A3: Limited approved uses, high R&D costs for new indications, regulatory hurdles, and competition from other therapies.

Q4: How significant are licensing revenues for companies developing LOXITANE?
A4: They typically range from $10 million to $50 million per milestone-based deal, depending on trial outcomes.

Q5: What trends could impact LOXITANE’s market in the next five years?
A5: Advances in neurodegenerative disease treatment, breakthroughs in gene therapy, and regulatory incentives for orphan drugs.

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References

1. GlobalData. "Urea cycle disorder therapeutics," 2022.
2. Fortune Business Insights. "Neurodegenerative Disease Treatment Market," 2022.
3. NIH ClinicalTrials.gov, 2023.