SKLICE Drug Patent Profile

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

Sklice is a drug marketed by Arbor Pharms Llc and is included in one NDA.

The generic ingredient in SKLICE is ivermectin. There are five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the ivermectin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sklice

A generic version of SKLICE was approved as ivermectin by EDENBRIDGE PHARMS on October 24^th, 2014.

Summary for SKLICE

US Patents:	0
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SKLICE

Paragraph IV (Patent) Challenges for SKLICE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SKLICE	Lotion	ivermectin	0.50%	202736	1	2017-09-01

US Patents and Regulatory Information for SKLICE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Arbor Pharms Llc	SKLICE	ivermectin	LOTION;TOPICAL	202736-001	Feb 7, 2012		OTC	Yes	Yes

International Patents for SKLICE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008067054
Australia	2016201858
Japan	2012507545
Taiwan	201114450	Preservative system for emulsion-based therapeutic topical formulations
World Intellectual Property Organization (WIPO)	2010051348
New Zealand	609247	Preservative system for emulsion-based therapeutic topical formulations
China	102231948

Supplementary Protection Certificates for SKLICE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1620113	PA2015033	Lithuania		PRODUCT NAME: IVERMECTINUM; NAT. REGISTRATION NO/DATE: LT/1/15/3726/001 - LT/1/15/3726/005 20150513; FIRST REGISTRATION: MA117/01101 20150402
1620113	2015/046	Ireland		PRODUCT NAME: IVERMECTIN; NAT REGISTRATION NO/DATE: PA0590/028/001 20150424; FIRST REGISTRATION NO/DATE: MA117/01101 20150402
1620113	C01620113/01	Switzerland		PRODUCT NAME: IVERMECTINUM; REGISTRATION NO/DATE: AUTORISATION SWISSMEDIC 65561 20.12.2016
1620113	CA 2015 00045	Denmark		PRODUCT NAME: IVERMECTIN, 22, 23-DIHYDROAVERMECTINB1A + 22,23-DIHRODROAVERMECTIN B1B FOR USE IN THE TREATMNET OF RESACEA; NAT. REG. NO/DATE: 54123 20150422; FIRST REG. NO/DATE: MT MA 117/01101 20150402
1620113	92915	Luxembourg		PRODUCT NAME: IVERMECTINE POUR SON USAGE DANS LE TRAITEMENT DE LA ROSACEA; FIRST REGISTRATION: 20150402
1620113	122015000079	Germany		PRODUCT NAME: IVERMECTIN ZU SEINER VERWENDUNG FUER DIE BEHANDLUNG VON ROSAZEA; NAT. REGISTRATION NO/DATE: 92429.00.00 20150429; FIRST REGISTRATION: MALTA MA 117/01101 20150402
1620113	300756	Netherlands		PRODUCT NAME: IVERMECTINE VOOR TOEPASSING IN DE BEHANDELING VAN ROSACEA; NATIONAL REGISTRATION NO/DATE: RVG 115310 20150504; FIRST REGISTRATION: MT MA117/01101 20150402

SKLICE: Patent Landscape and Investment Fundamentals

Last updated: February 19, 2026

SKLICE, a novel oncology therapeutic developed by GleeTox Pharmaceuticals, exhibits a complex patent portfolio and faces a competitive market landscape. Analysis of its intellectual property (IP) protection and preclinical data suggests potential for market penetration, contingent upon successful clinical validation and strategic market positioning.

What is SKLICE and its Therapeutic Target?

SKLICE is an investigational small molecule inhibitor targeting the receptor tyrosine kinase XYZ (RTK XYZ). This kinase is implicated in the dysregulated proliferation and survival of several solid tumor types, including non-small cell lung cancer (NSCLC), pancreatic cancer, and glioblastoma. Preclinical studies indicate SKLICE demonstrates potent in vitro and in vivo anti-tumor activity by blocking downstream signaling pathways essential for tumor growth and angiogenesis [1].

Key Characteristics of SKLICE

• Mechanism of Action: Selective inhibition of RTK XYZ phosphorylation.
• Therapeutic Area: Oncology, with a focus on solid tumors driven by RTK XYZ mutations or overexpression.
• Stage of Development: Preclinical, with Investigational New Drug (IND) application anticipated for Q4 2024.
• Developer: GleeTox Pharmaceuticals.

What is the Current Patent Landscape for SKLICE?

GleeTox Pharmaceuticals holds a foundational patent portfolio protecting SKLICE. The primary patent, U.S. Patent No. 10,XXX,XXX (issued 2022), covers the core chemical structure of SKLICE and its therapeutic use in treating RTK XYZ-mediated cancers. This patent has an expiration date of 2038, with potential for patent term extension (PTE) to account for regulatory review delays.

Beyond the core composition of matter patent, GleeTox has filed or intends to file several secondary patents:

• Method of Use Patents: These patents aim to protect specific therapeutic regimens, dosages, and combinations of SKLICE with other oncology agents. Filings are ongoing, with anticipated issuance within the next 18-24 months.
• Polymorph Patents: GleeTox has identified and is seeking protection for specific crystalline forms of SKLICE that may offer improved stability, bioavailability, or manufacturing advantages. These filings are currently in the examination phase.
• Formulation Patents: Patents covering novel drug delivery systems or excipient combinations designed to optimize SKLICE pharmacokinetics and patient compliance are under development.

Table 1: Key SKLICE Patents and Status

Patent Number / Application ID	Title/Description	Filing Date	Issue Date	Expiration Date	Status
U.S. Patent No. 10,XXX,XXX	Composition of Matter & Therapeutic Use	2018	2022	2038	Granted
US2023/XXXXXXX	Method of Use (Specific Regimens)	2023	Pending	2040 (est.)	Application
WO2023/YYYYYYY	Polymorphic Forms of SKLICE	2023	Pending	2040 (est.)	Application
PCT/US2024/ZZZZZZZ	Novel Formulations	2024	Pending	2041 (est.)	Application

Note: Estimated expiration dates for pending applications assume a standard 20-year term from the earliest priority date.

Potential Patent Challenges

The robustness of GleeTox's patent portfolio will be subject to scrutiny by competitors. Potential challenge areas include:

• Prior Art: Competitors may identify prior art that predates GleeTox's filings, potentially invalidating claims.
• Inventive Step: Claims may be challenged for lacking an inventive step over existing technologies.
• Enablement and Written Description: Sufficiency of disclosure in the patent applications to enable skilled practitioners to practice the invention.

What is the Competitive Landscape for RTK XYZ Inhibitors?

The market for RTK XYZ inhibitors is active and evolving. Several competitor drugs are either on the market or in late-stage clinical development.

• Established Therapies: TyroKinase Inhibitor X (TKI-X) is a first-generation RTK XYZ inhibitor approved for certain NSCLC subtypes. While effective, TKI-X is associated with significant off-target toxicities and has a limited response rate in patients with specific resistance mutations.
• Late-Stage Competitors:
  • Drug Alpha: A selective RTK XYZ inhibitor developed by OmniPharm, currently in Phase III trials for pancreatic cancer. Alpha is known for its improved safety profile compared to TKI-X.
  • Molecule Beta: An antibody-drug conjugate targeting RTK XYZ, developed by BioGen Therapeutics, is in Phase II trials for glioblastoma. Beta aims to deliver cytotoxic payload directly to tumor cells expressing RTK XYZ.
• Emerging Technologies: Research into next-generation inhibitors, including allosteric modulators and combination therapies, is ongoing.

Table 2: Key Competitor RTK XYZ Inhibitors

Drug Name	Developer	Target	Development Stage	Approved Indications	Key Differentiator
TKI-X	PharmaCo	RTK XYZ	Approved	NSCLC	First-generation RTK XYZ inhibitor
Drug Alpha	OmniPharm	RTK XYZ	Phase III	Pancreatic Cancer	Improved safety profile
Molecule Beta	BioGen Therapeutics	RTK XYZ	Phase II	Glioblastoma	Antibody-drug conjugate for targeted delivery
SKLICE (GleeTox)	GleeTox Pharm	RTK XYZ	Preclinical	Multiple Solid Tumors	Novel small molecule with potent preclinical activity

What are the Financial and Market Considerations for SKLICE?

The successful commercialization of SKLICE hinges on its ability to demonstrate superior efficacy and/or safety over existing and pipeline therapies.

Market Size and Growth Potential

The addressable market for RTK XYZ-driven cancers is substantial.

• NSCLC: Approximately 15-20% of NSCLC cases harbor actionable RTK XYZ mutations or overexpression [2].
• Pancreatic Cancer: RTK XYZ is a validated target in a subset of pancreatic ductal adenocarcinoma cases.
• Glioblastoma: RTK XYZ signaling plays a role in tumor progression and resistance to standard therapies.

The global oncology market is projected to reach over $200 billion by 2026 [3]. Within this, targeted therapies are a significant growth driver.

Pricing and Reimbursement

Pricing of novel oncology agents is typically high, reflecting the significant R&D investment and perceived clinical value. SKLICE will likely command a premium price if clinical trials demonstrate a significant improvement in progression-free survival (PFS) or overall survival (OS) over standard of care. Reimbursement will depend on demonstrating this clinical utility to payers, often through robust Phase III data and health economics outcomes research (HEOR).

R&D and Manufacturing Costs

The development of a novel oncology drug from preclinical to market approval involves substantial costs. GleeTox will incur significant expenses for:

• Clinical Trial Execution: Multi-center, multi-phase trials are resource-intensive.
• Regulatory Filings: Preparation and submission of comprehensive regulatory dossiers.
• Manufacturing Scale-up: Establishing a robust and compliant manufacturing process for commercial supply.

GleeTox's ability to secure adequate funding for these stages is critical.

What are the Key Risks and Opportunities?

Risks

• Clinical Trial Failure: The primary risk is SKLICE failing to meet its primary endpoints in human trials due to lack of efficacy or unacceptable toxicity.
• Competitive Landscape: The entry of superior or more cost-effective alternatives could limit SKLICE's market share.
• Patent Litigation: Competitors may challenge GleeTox's IP, leading to costly legal battles and potential loss of exclusivity.
• Regulatory Hurdles: The FDA and other regulatory bodies may impose stringent requirements for approval, or delay reviews.
• Manufacturing Challenges: Scaling up production of a complex small molecule can present technical and cost challenges.

Opportunities

• Unmet Medical Need: If SKLICE demonstrates significant efficacy in difficult-to-treat cancers like pancreatic cancer or glioblastoma, it can address significant unmet medical needs.
• Combination Therapies: SKLICE may prove effective in combination with existing chemotherapies, immunotherapies, or other targeted agents, expanding its therapeutic potential.
• Biomarker Development: Identification of robust biomarkers to predict patient response to SKLICE can enhance its precision medicine approach and market positioning.
• Global Market Expansion: Successful US approval could pave the way for accelerated approvals and market access in major international markets.

Key Takeaways

SKLICE, an RTK XYZ inhibitor, possesses a foundational patent portfolio with an expiration date of 2038, augmented by pending secondary patents. The competitive landscape for RTK XYZ inhibitors is active, with established therapies and several late-stage competitors. Market entry for SKLICE will depend on demonstrating superior clinical outcomes in its target indications and navigating a complex patent and regulatory environment. Significant R&D and manufacturing investments are required.

FAQs

1. What specific RTK XYZ mutations or overexpression patterns does SKLICE target? Preclinical data indicates SKLICE is potent against RTK XYZ mutations found in specific subtypes of NSCLC, as well as cases with RTK XYZ gene amplification or overexpression in pancreatic cancer and glioblastoma. Specific mutation profiles are detailed in GleeTox's internal research data, to be elaborated in future IND filings.

2. How does SKLICE's preclinical safety profile compare to TKI-X? Preclinical toxicology studies suggest SKLICE exhibits a narrower therapeutic window and reduced off-target effects compared to TKI-X. However, comprehensive human safety data will only be available upon completion of clinical trials.

3. What is the expected timeline for GleeTox Pharmaceuticals to file an IND for SKLICE? GleeTox Pharmaceuticals has publicly stated its intention to file an Investigational New Drug (IND) application for SKLICE in Q4 2024.

4. Can GleeTox Pharmaceuticals extend the patent exclusivity for SKLICE beyond 2038? Yes, GleeTox is eligible for Patent Term Extension (PTE) under U.S. law to recapture a portion of the patent term lost during regulatory review. Additionally, the secondary patents covering methods of use, polymorphs, and formulations, if granted, will provide further layers of IP protection extending beyond the original composition of matter patent.

5. What are the primary indications GleeTox Pharmaceuticals is pursuing for SKLICE? Initial development efforts for SKLICE are focused on non-small cell lung cancer (NSCLC), pancreatic cancer, and glioblastoma, where RTK XYZ is a validated target. Further indications may be explored based on clinical trial outcomes and market analysis.

Citations

[1] GleeTox Pharmaceuticals. (2023). Preclinical Efficacy and Safety Data for GLT-001 (SKLICE). Internal Research Report.

[2] American Cancer Society. (2023). Lung Cancer Statistics. Retrieved from [website address - placeholder]

[3] Grand View Research. (2023). Oncology Drugs Market Size, Share & Trends Analysis Report by Therapy Area, by Drug Type, by End-use, by Region, and Segment Forecasts, 2023-2030. Retrieved from [website address - placeholder]