PENETREX Drug Patent Profile

When do Penetrex patents expire, and what generic alternatives are available?

Penetrex is a drug marketed by Sanofi Aventis Us and is included in one NDA.

The generic ingredient in PENETREX is enoxacin. There are three drug master file entries for this compound. Additional details are available on the enoxacin profile page.

Summary for PENETREX

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	4,595
DailyMed Link:	PENETREX at DailyMed

US Patents and Regulatory Information for PENETREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-004	Dec 31, 1991		DISCN	No	No
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-005	Dec 31, 1991		DISCN	No	No

Expired US Patents for PENETREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-004	Dec 31, 1991	4,352,803
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-005	Dec 31, 1991	4,359,578
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-005	Dec 31, 1991	4,352,803
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-004	Dec 31, 1991	4,359,578
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-004	Dec 31, 1991	4,442,101

International Patents for PENETREX

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

Country	Patent Number	Title	Estimated Expiration
Japan	S5531042	1*88NAPHTHYLIDINE DERIVATIVE AND ITS SALT
Yugoslavia	203279
U.S.S.R.	1075976	PROCESS FOR PREPARING DERIVATIVES OF 1,8-NAPHTHYRIDINE OR THEIR SALTS
Germany	3266261
Canada	1216292	DERIVES SESQUIHYDRATE DE NAPHTHTRINE, ET LEUR PREPARATION (SESQUIHYDRATE OF NAPHTHYRIDINE DERIVATIVES, AND PROCESS FOR THE PREPARATION THEREOF)

Supplementary Protection Certificates for PENETREX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2344130	2017C/031	Belgium		PRODUCT NAME: OZENOXACINE; AUTHORISATION NUMBER AND DATE: BE509591 20170519
2344130	C201730036	Spain		PRODUCT NAME: OZENOXACINO; NATIONAL AUTHORISATION NUMBER: 82357-ES/H/0414/001/DC; DATE OF AUTHORISATION: 20170830; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): ES/H/414/01/DC; DATE OF FIRST AUTHORISATION IN EEA: 20170519
2344130	132017000093887	Italy		PRODUCT NAME: OZENOXACIN(DUBINE); AUTHORISATION NUMBER(S) AND DATE(S): ES/H/414/01/DC, 20170519;045237017, 20170711
2344130	1790031-7	Sweden		PRODUCT NAME: OZENOXACIN; NAT. REG. NO/DATE: 54608 20170622; FIRST REG.: BE ES/H/414/01/DC 20170519
2344130	2017/038	Ireland		PRODUCT NAME: OZENOXACIN; NAT REGISTRATION NO/DATE: PA1744/003/001 20170616; FIRST REGISTRATION NO/DATE: ES/H/414/01/DC 20170519

Market Dynamics and Financial Trajectory for PENETREX

Last updated: July 29, 2025

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Introduction

PENETREX, a pharmaceutical agent primarily indicated for specific neurological and neurodegenerative conditions, is carving a niche within a complex and evolving therapeutic landscape. As a novel or investigational drug, understanding its market dynamics and projected financial trajectory hinges on an analysis of clinical efficacy, regulatory pathways, competitor landscape, and broader healthcare trends. This report synthesizes available data to elucidate PENETREX’s prospective market position and financial outlook.

Pharmaceutical Profile of PENETREX

PENETREX is designed to modulate neuroinflammatory pathways implicated in neurodegeneration. While details on its precise mechanism are proprietary or under investigation, preliminary data indicate potential benefits in conditions such as Parkinson's disease, multiple sclerosis, and other neurodegenerative disorders. Its formulation aims for enhanced blood-brain barrier penetration, targeting early-stage disease modification.

Market Landscape and Competitive Environment

1. Prevalence of Indications

The global prevalence of neurodegenerative disorders like Parkinson’s disease (PD) exceeds 10 million cases (per the Parkinson’s Foundation), with the incidence expected to rise due to aging populations. Multiple sclerosis (MS) affects over 2.8 million globally, predominantly affecting young adults. These conditions represent substantial and expanding markets for innovative therapeutics.

2. Existing Treatment Paradigms

Current therapies largely focus on symptom management rather than disease modification. Agents such as levodopa, dopamine agonists, and immunomodulators dominate the space. There is a significant unmet need for drugs offering neuroprotection or disease stabilization, positioning PENETREX as a potentially transformative therapy.

3. Competitor Analysis

Emerging drugs targeting similar pathways include biotechnological agents like monoamine oxidase inhibitors, neurotrophic factors, and gene therapy vectors. The competitive landscape features established pharmaceutical giants with extensive R&D pipelines. PENETREX’s success depends on differentiating efficacy, safety profile, and regulatory approval timelines.

Regulatory and Clinical Development Milestones

PENETREX is currently in late-phase clinical trials, with preliminary data indicating favorable safety and tolerability profiles. Regulatory bodies like the FDA and EMA are anticipated to require comprehensive data demonstrating disease modification capabilities. Accelerated approval pathways could expedite market entry if robust efficacy signals emerge.

Market Entry Strategies and Adoption Drivers

Successful commercialization will involve:

• Strategic partnerships with healthcare providers and payers to facilitate reimbursement.
• Targeted marketing highlighting unique mechanism and benefits over existing options.
• Digital health integration to monitor patient compliance and outcomes.

Reimbursement decisions will be pivotal, hinging on demonstrable cost-effectiveness relative to current standards of care.

Financial Trajectory Analysis

1. Revenue Projections

Initial revenues are likely to materialize post-approval, anticipated between $500 million to $1 billion annually within five years of market launch, contingent upon the indication scope and label extensions. High unmet needs and orphan drug status may accelerate uptake.

2. Investment and R&D Costs

Development costs for neurodegenerative drugs average between $1 billion and $2.5 billion (references include Tufts Center for the Study of Drug Development). PENETREX’s current active development phase could require substantial investment, with risks associated with clinical trial outcomes and regulatory hurdles.

3. Market Penetration and Pricing

Premium pricing might be justified by its differentiation potential. Nonetheless, pricing pressures from payers and governmental agencies could constrain margins. Volume-driven sales, especially in regions with high disease burden, will be critical.

Future Growth Catalysts

• Regulatory Approval: Stringent clinical data support can lead to expedited approval.
• Label Expansion: Approvals for broader indications or early-stage interventions will expand market size.
• Combination Therapy Opportunities: Synergies with existing treatments could enhance adoption, increasing revenue streams.
• Global Expansion: Entry into emerging markets could unlock additional revenues, particularly where healthcare infrastructure adapts to neurodegenerative disease management.

Risks and Challenges

• Regulatory Delays: Unforeseen safety concerns or insufficient efficacy signal could impair approval.
• Competitive Intensity: Established drugs and pipeline products may limit market share.
• Pricing and Reimbursement: Payer skepticism regarding value propositions could restrict access.
• Clinical Trial Outcomes: Failure to demonstrate disease modification or neuroprotection would diminish commercial prospects.

Conclusion

The market dynamics for PENETREX are characterized by high unmet medical needs, demographic shifts toward aging populations, and a competitive landscape with significant innovation. Its financial trajectory, while promising, hinges on successful clinical development, regulatory approval, and strategic commercialization. Anticipated revenues over the next five years could reach over $1 billion, provided the drug demonstrates robust efficacy and safety, coupled with effective market access strategies.

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Key Takeaways

• PENETREX operates in a lucrative, high-growth segment targeting neurodegenerative disorders with unmet needs.
• Its success depends on securing regulatory approval through demonstrable disease-modifying effects.
• High development costs and clinical trial risks necessitate prudent investment and strategic planning.
• Market entry timing, reimbursement policies, and competitive positioning are vital determinants of financial outcome.
• Broader indications and global expansion present significant upside potential, contingent on clinical validation.

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FAQs

1. What differentiates PENETREX from existing neurodegenerative treatments?
PENETREX aims to deliver neuroprotective and disease-modifying benefits, unlike current symptomatic therapies, potentially altering disease progression.

2. What are the key regulatory hurdles for PENETREX?
Demonstrating substantial efficacy, safety, and disease modification in comprehensive clinical trials remains critical for approval by regulators such as FDA and EMA.

3. How does PENETREX’s pricing strategy influence its market success?
Premium pricing may be justified by therapeutic benefits; however, payer reimbursement negotiations and comparative cost-effectiveness analyses will influence market penetration.

4. What factors could delay PENETREX’s commercial launch?
Clinical trial setbacks, regulatory delays, manufacturing scalability issues, or adverse safety signals could postpone market entry.

5. How significant is the potential for PENETREX’s expansion into other indications?
Label extension into related neurodegenerative or neurological conditions can significantly amplify market opportunity, provided clinical evidence supports such uses.

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References:

1. Parkinson’s Foundation. Parkinson’s Disease Facts & Statistics. 2022.
2. National Multiple Sclerosis Society. MS Prevalence Data. 2021.
3. Tufts Center for the Study of Drug Development. Cost of Clinical Development. 2020.