VYBRIQUE Drug Patent Profile

When do Vybrique patents expire, and when can generic versions of Vybrique launch?

Vybrique is a drug marketed by Ibsa and is included in one NDA. There is one patent protecting this drug.

This drug has twelve patent family members in eleven countries.

The generic ingredient in VYBRIQUE is sildenafil citrate. There are twenty drug master file entries for this compound. Sixty-two suppliers are listed for this compound. Additional details are available on the sildenafil citrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vybrique

A generic version of VYBRIQUE was approved as sildenafil citrate by CHARTWELL RX on November 6^th, 2012.

Summary for VYBRIQUE

International Patents:	12
US Patents:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for VYBRIQUE

VYBRIQUE is protected by one US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ibsa	VYBRIQUE	sildenafil citrate	FILM;ORAL	210858-001	Dec 16, 2025		RX	Yes	No	11,123,287		Y
Ibsa	VYBRIQUE	sildenafil citrate	FILM;ORAL	210858-004	Dec 16, 2025		RX	Yes	Yes	11,123,287		Y
Ibsa	VYBRIQUE	sildenafil citrate	FILM;ORAL	210858-002	Dec 16, 2025		RX	Yes	No

International Patents for VYBRIQUE

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

Country	Patent Number	Title	Estimated Expiration
Poland	2900215
Russian Federation	2015115920
World Intellectual Property Organization (WIPO)	2014049548

Supplementary Protection Certificates for VYBRIQUE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0463756	5/1999	Austria		PRODUCT NAME: ''SILDENAFIL'' UND DESSEN PHARMAZEUTISCH ANNEHMBAREN SALZE, EINSCHLIESSLICH DES CITRATS; NAT. REGISTRATION NO/DATE: EU/1/98/077/001 - EU/1/98/077/012 19980914; FIRST REGISTRATION: LI 54642 01-54642 03 19980622
0463756	C990005	Netherlands		PRODUCT NAME: SILDENAFIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT, IN HET BIJZONDER SILDENAFIL CITRAAT; NATL REGISTRATION NO/DATE: EU/1/98/077/001-012 19980914; FIRST REGISTRATION: CH 54642 19980622
0463756	SPC/GB99/004	United Kingdom		PRODUCT NAME: SILDENAFIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE CITRATE SALT; REGISTERED: CH 54642 19980622; UK EU/1/98/077/001 19980914; UK EU/1/98/077/002 19980914; UK EU/1/98/077/003 19980914; UK EU/1/98/077/004 19980914; UK EU/1/98/077/005 19980914; UK EU/1/98/077/006 19980914; UK EU/1/98/077/007 19980914; UK EU/1/98/077/008 19980914; UK EU/1/98/077/009 19980914; UK EU/1/98/077/010 19980914; UK EU/1/98/077/011 19980914; UK EU/1/98/077/012 19980914

VYBRIQUE Investment Scenario and Fundamentals Analysis

Last updated: February 10, 2026

Overview

VYBRIQUE (sagopilone) is an experimental anticancer drug developed by CytRx Corporation aimed at treating advanced ovarian and breast cancers. Its development status, competitive landscape, and market potential underpin its investment profile.

Regulatory and Development Status

• Phase: VYBRIQUE has completed early-phase clinical trials; no current FDA approval.
• Indication: Oncology, specifically ovarian and breast cancers resistant to standard therapies.
• Trial Data: Phase 1/2 studies demonstrated favorable tolerability and signs of efficacy, but statistical significance and overall survival benefits remain uncertain.
• Regulatory Pathway: Possible pursuing of Breakthrough Therapy designation or Orphan Drug status to accelerate development.

Market Perspective

• Market Size: The global ovarian cancer market was valued at approximately US$1.2 billion in 2022, with an expected CAGR of 8%, reaching $2 billion by 2030. Breast cancer dominates cancer markets with a valuation exceeding US$20 billion globally.
• Unmet Need: Resistance to existing chemotherapies and targeted agents creates demand for novel treatments like VYBRIQUE.
• Competitive Landscape: Competes with established therapies such as PARP inhibitors (olaparib, niraparib), antibody-drug conjugates, and emerging immunotherapies. No approved drugs with identical mechanisms—sagopilone’s tubulin polymerization inhibition sets it apart.

Financial Fundamentals and Investment Considerations

• Development Costs: Estimated at $50-100 million for full clinical development if progressing rapidly. Company has limited cash flow, relying on external funding or partnerships.
• Partnership Potential: Larger pharma companies may license early-stage assets for co-development, providing upfront payments and milestone-based payments.
• Intellectual Property: Patent protection granted until 2035. Patent covers manufacturing process and formulation.
• Funding and Market Capitalization: As of 2023, CytRx’s market cap approximates $15 million, reflecting high risk, early-stage status.

Risks

• Clinical Efficacy: Partial or ambiguous trial results may hinder progression.
• Regulatory Approval: Delays or rejection due to safety or efficacy concerns.
• Competitive Pressure: Existing and pipeline therapies may dilute market share for VYBRIQUE.
• Funding: Sustained investment required; failure to secure funding impairs development.

Growth and Exit Strategies

• Partnerships: Out-licensing to larger pharma firms could generate initial revenue.
• Acquisition: Larger pharmaceutical companies may acquire to accelerate development or expand pipeline.
• Market Entry: Successful trials could lead to regulatory approval, followed by commercialization, but facing significant hurdles in commercialization scale and reimbursement.

Key Takeaways

• VYBRIQUE remains experimental, with promising but inconclusive clinical data.
• The drug occupies a niche market with high unmet need but faces strong competition.
• Investment requires high risk tolerance; success hinges on positive trial outcomes and regulatory approval.
• Strategic partnerships or acquisitions could de-risk investment and facilitate commercialization.
• Ongoing clinical trials and corporate developments should be monitored closely for updates.

FAQs

1. What is VYBRIQUE’s primary mechanism of action?
   It inhibits tubulin polymerization, affecting cell division in cancer cells.

2. Has VYBRIQUE received regulatory approval?
   No, it has completed early clinical trials but awaits further data for approval.

3. What are the main competitors for VYBRIQUE?
   PARP inhibitors, antibody-drug conjugates, and immunotherapies targeting ovarian and breast cancers.

4. What factors could drive VYBRIQUE’s market potential?
   Efficacy in resistant cancer types, favorable safety profile, and accelerated regulatory pathways.

5. What investments are most suitable for VYBRIQUE?
   High-risk, high-reward investments, particularly in early licensing, partnership, or acquisition scenarios.

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Sources

1. Grand View Research, "Ovarian Cancer Therapeutics Market Size, Share & Trends," 2022.
2. ClinicalTrials.gov, VYBRIQUE trial data.
3. CytRx Corporate Filings, 2023.
4. MarketWatch, "Cancer Drug Market Outlook," 2023.
5. PatentScope, Patent filings related to sagopilone, 2005-2022.