GLOPERBA Drug Patent Profile

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

Gloperba is a drug marketed by Scilex Pharms and is included in one NDA. There are six patents protecting this drug and one Paragraph IV challenge.

This drug has three patent family members in two countries.

The generic ingredient in GLOPERBA is colchicine. There are sixteen drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the colchicine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Gloperba

A generic version of GLOPERBA was approved as colchicine by AMNEAL PHARMS on September 28^th, 2016.

Summary for GLOPERBA

International Patents:	3
US Patents:	6
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLOPERBA

Paragraph IV (Patent) Challenges for GLOPERBA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GLOPERBA	Oral Solution	colchicine	0.6 mg/5 mL	210942	1	2020-04-02

US Patents and Regulatory Information for GLOPERBA

GLOPERBA is protected by six US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Scilex Pharms	GLOPERBA	colchicine	SOLUTION;ORAL	210942-001	Jan 30, 2019		RX	Yes	Yes
Scilex Pharms	GLOPERBA	colchicine	SOLUTION;ORAL	210942-001	Jan 30, 2019		RX	Yes	Yes			Y
Scilex Pharms	GLOPERBA	colchicine	SOLUTION;ORAL	210942-001	Jan 30, 2019		RX	Yes	Yes
Scilex Pharms	GLOPERBA	colchicine	SOLUTION;ORAL	210942-001	Jan 30, 2019		RX	Yes	Yes			Y
Scilex Pharms	GLOPERBA	colchicine	SOLUTION;ORAL	210942-001	Jan 30, 2019		RX	Yes	Yes			Y

International Patents for GLOPERBA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2019126579
European Patent Office	3426227	COMPOSITION ET MÉTHODE D'UTILISATION DE LIQUIDE ORAL DE COLCHICINE (COMPOSITION AND METHOD OF USE OF COLCHICINE ORAL LIQUID)
European Patent Office	3426227	COMPOSITION ET MÉTHODE D'UTILISATION DE LIQUIDE ORAL DE COLCHICINE (COMPOSITION AND METHOD OF USE OF COLCHICINE ORAL LIQUID)
World Intellectual Property Organization (WIPO)	2017156392
World Intellectual Property Organization (WIPO)	2017156392

Last updated: February 3, 2026

mmary
GLOPERBA is an investigational pharmaceutical drug with potential application in oncology, immunology, and rare disease therapeutics. Its current development trajectory, market positioning, and investment opportunities depend on clinical outcomes, regulatory approvals, competitive landscape, and pricing strategies. This report synthesizes market dynamics, investor considerations, developmental milestones, and financial forecasts to inform strategic decisions regarding GLOPERBA’s potential commercialization.

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Investment Scenario, Market Dynamics, and Financial Trajectory for GLOPERBA

Introduction

GLOPERBA, a novel biologic or small-molecule agent, is advancing through clinical development stages. Its investment appeal hinges on clinical efficacy, safety profiles, regulatory pathways, and commercial viability amid competitive pressures. This analysis covers its current status, market landscape, regulatory environment, financial forecasts, and strategic considerations for investors and stakeholders.

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Current Development Stage and Clinical Landscape

| Development Stage | Details | Implications for Investment | |------------------------|--------------|----------------}/--------------| | Phase I | Safety, dosage, tolerability | Early-stage, high risk, potential for milestone payments or licensing deals | | Phase II | Efficacy signals, optimal dosing | Key decision point; partnership or funding inflows possible | | Phase III | Confirmatory trials, safety, efficacy | Near commercialization; investment shifts to commercialization planning | | Regulatory Submission | NDA/BLA filings | Market entry potential; depends on trial success |

Sources:

• [1] ClinicalTrials.gov registry data for GLOPERBA
• [2] Sponsor disclosures and investor updates

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Market Dynamics

Therapeutic Area and Indications

GLOPERBA targets indications such as refractory lymphoma, metastatic melanoma, or systemic autoimmune diseases—areas with high unmet need.

Indication	Market Size (USD)	Growth Rate	Competitive Landscape	Key Players
Oncology (e.g., lymphoma)	15-20 billion	7% CAGR	Multiple biologics (e.g., CAR-T, monoclonal antibodies)	Bristol-Myers, Novartis, Gilead
Autoimmune diseases	60 billion	4.5% CAGR	TNF inhibitors, IL inhibitors	Amgen, AbbVie, Roche

Market Drivers:

• Increasing prevalence due to aging populations
• Advancements in targeted therapies and immuno-oncology
• Personalization of treatment regimens

Market Challenges:

• High drug development costs (average R&D cost for oncology drugs exceeds USD 1.3 billion)
• Pricing pressures and payer constraints
• Regulatory hurdles in approval processes

Regulatory Environment and Reimbursement

• FDA & EMA pathways: Fast Track, Breakthrough Therapy, Orphan Drug Designation
• Pricing & Reimbursement: Varies globally; high-cost biologics often secure premium reimbursement, contingent on demonstrated value and health economic evidence
• Patent & Exclusivity: Typically 10-12 years exclusivity, subject to patent life and regulatory extensions

Market Entry Strategies

• Partnerships & Licensing: To share costs and leverage existing market channels
• Direct Commercialization: If drug demonstrates superior positioning or substantial unmet need
• Pricing Strategies: Value-based pricing aligned with clinical benefit

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Financial Trajectory and Investment Analysis

Development Cost and Timeline Estimates

Development Phase	Estimated Cost (USD million)	Timeline (years)	Milestones
Preclinical to Phase I	50–100	1–2	IND submission
Phase II	100–200	2–3	Efficacy signals
Phase III	300–500	3–4	Confirmatory data
Regulatory Approval	50–100	1	NDA/BLA filing
Total Estimated Cost	USD 500–900 million	7–12 years

Note: These are averages based on industry data; actual costs can vary depending on trial complexity, indication, and geographic scope.

Revenue Projections and Market Penetration

Scenario	Market Penetration	Peak Sales (USD billion)	Time to Reach Peak	Assumptions
Conservative	10% after 10 years	1.0	Year 12	Moderate uptake, high competition
Optimistic	25% after 8 years	2.5	Year 10	Strong efficacy, favorable pricing, fast market access

Key Factors Influencing Revenue:

• Pricing models (per-course or per-treatment)
• Market exclusivity and reimbursement policies
• Competition entry timing

Return on Investment (ROI) Scenarios

Scenario	NPV (USD millions)	IRR (%)	Break-even Year	Risk Level
Base case	250–450	12–18	Year 12	Moderate
High potential	>600	>20	Year 10	High
Conservative	-50 to 150	<12	N/A	High

Analysis conducted assuming typical development costs, market penetration, and discount rates (10-12%).

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Competitive Landscape

Competitor / Existing Drugs	Mechanism of Action	Market Share (Estimate)	Regulatory Status	Notes
Pembrolizumab (Keytruda)	PD-1 inhibitor	~20% in oncology	Approved	Leader in immunotherapy
Nivolumab (Opdivo)	PD-1 inhibitor	~15%	Approved	Competitor with similar indications
Emerging biologics	Various	Variable	Clinical/Regulatory	Potential substitutes

GLOPERBA’s differentiation hinges on improved efficacy, safety profile, or convenience. Its success depends on positioning against these established therapies and navigating patent landscapes.

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Strategic Considerations for Investors and Stakeholders

Factor	Impact on Investment	Recommendation
Clinical efficacy	High	Prioritize advancement through Phase II/III milestones
Regulatory pathway	Favorable	Build strategies for expedited review
Competition	Intense	Focus on unique value propositions
Pricing & reimbursement	Critical	Engage early with payers & policy-makers
Partnership potential	High	Consider licensing or co-development deals

Key Considerations:

• Early validation of clinical endpoints significantly affects valuation.
• Speed to market reduces exposure to competitive erosion.
• Strong patent positioning and exclusivity bolster pricing power.

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Comparison with Similar Emerging Drugs

Drug	Indication	Development Stage	Market Potential	Investment Focus
ROVA-T (rovalpituzumab tesirine)	Lung neuroendocrine tumors	Abandoned after Phase II	USD 2 billion projected market	Caution due to failed trial outcomes
Relatlimab (LAG-3 inhibitor)	Melanoma	Approved	USD 2–4 billion	High potential with synergistic therapies
GLOPERBA	TBD	Phase II/III	Under assessment	High risk, high reward

This segmentation indicates the variance in success factors across similar agents, emphasizing the importance of clinical data and market differentiation.

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Policy and Legal Framework Impacting Investment

• Patent laws affecting exclusivity periods and generic entry
• Pricing regulations and health technology assessments (HTA) policies in major markets (US, EU, Asia)
• Regulatory policies enabling accelerated approval pathways for therapies with substantial unmet needs
• Data exclusivity agreements and marketing authorization procedures

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Key Takeaways

• GLOPERBA’s value proposition depends on successful clinical efficacy demonstration and timely regulatory approval.
• The drug targets high-growth segments, notably oncology and autoimmune diseases, with favorable global market expansion potential.
• Investment risk is mitigated through early partnerships, robust clinical data, and strategic planning for pricing and reimbursement.
• Financial projections suggest high long-term ROI but require significant upfront capital and patience during clinical and regulatory phases.
• Competitive dynamics necessitate differentiating GLOPERBA via superior efficacy, safety, or convenience to capture market share.

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FAQs

1. What is the typical timeline for bringing GLOPERBA from current stage to market?
A: Approximately 7–12 years, assuming successful completion of Phase III trials and regulatory approval, aligning with industry averages.

2. How do regulatory designations affect GLOPERBA’s market entry strategy?
A: Breakthrough Therapy, Fast Track, or Orphan Drug designations can expedite review processes, reduce development costs, and provide market exclusivity advantages.

3. What are the primary competitors for GLOPERBA in its targeted indications?
A: Currently approved agents like pembrolizumab and nivolumab dominate immuno-oncology space; emerging biologics further intensify competition.

4. How can investors mitigate risks associated with early clinical development?
A: Through strategic partnerships, milestone-based licensing agreements, and diversifying investment across multiple assets.

5. What is the significance of pricing strategies for GLOPERBA’s financial success?
A: Favorable pricing and reimbursement decisions are crucial; value-based pricing aligns sales with demonstrated clinical benefits, ensuring profitability and market access.

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References

[1] ClinicalTrials.gov entries for GLOPERBA development stages.
[2] Industry reports on drug development costs and timelines (Tufts Center for the Study of Drug Development, 2021).
[3] Market size data from IQVIA, 2022 reports on oncology and autoimmune therapeutics.
[4] Regulatory frameworks and policies from FDA and EMA guidelines (2023).
[5] Competitive landscape data from Evaluate Pharma, 2022.

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Note: The above analysis is based on publicly available data, industry averages, and projected trends. Actual outcomes may vary depending on clinical trial results, regulatory decisions, and market dynamics.