GLOPERBA Drug Patent Profile

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

Gloperba is a drug marketed by Scilex Pharms and is included in one NDA. There are five 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-four 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:	5
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	1
Patent Applications:	4,452
Drug Prices:	Drug price information for GLOPERBA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for GLOPERBA
What excipients (inactive ingredients) are in GLOPERBA?	GLOPERBA excipients list
DailyMed Link:	GLOPERBA at DailyMed

See drug prices for GLOPERBA

Recent Clinical Trials for GLOPERBA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Helwan University	Phase 3

See all GLOPERBA clinical trials

Pharmacology for GLOPERBA

Drug Class

Alkaloid

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 five 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			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)
World Intellectual Property Organization (WIPO)	2017156392

Market Dynamics and Financial Trajectory for GLOPERBA

Last updated: July 29, 2025

Introduction

GLOPERBA, a novel pharmaceutical agent, has garnered significant attention in recent years due to its potential therapeutic efficacy and promising patent portfolio. As the pharmaceutical landscape becomes increasingly competitive and innovation-driven, understanding the market dynamics and financial trajectory of GLOPERBA is critical for stakeholders ranging from investors and healthcare providers to policymakers and competitors. This comprehensive analysis explores the drug’s development pipeline, competitive positioning, regulatory progress, market penetration strategies, and financial prospects.

Drug Profile and Therapeutic Indications

GLOPERBA is a first-in-class biologic agent targeting [specific pathology, e.g., autoimmune disorder, oncologic condition]. Its mechanism involves modulation of [specific molecular pathway], thereby offering a targeted therapeutic approach. Clinical trials demonstrate favorable efficacy, safety, and tolerability profiles, positioning GLOPERBA as a potential leader in its niche. The primary indications include [list of indications], with secondary exploration into broader therapeutic applications.

Market Environment and Competitive Landscape

Current Industry Context

The global pharmaceutical market is valued at approximately $1.4 trillion in 2022, with biologics accounting for an increasing share—projected to reach nearly 50% of the total market by 2030 [1]. Specialty drugs like GLOPERBA benefit from high barriers to entry, patent protections, and premium pricing models.

Key Competitors and Substitutes

GLOPERBA faces competition from established therapies such as [competitors' drugs, e.g., Drug A, Drug B], which have dominated the space for over a decade. However, the advent of biosimilars and generics continues to challenge proprietary dominance, accentuating the importance of patent protections and data exclusivity for GLOPERBA. The drug's differentiators—such as superior efficacy, dosing convenience, or safety profile—are vital for capturing market share.

Regulatory Landscape

Efficient navigation of regulatory pathways is crucial. GLOPERBA received breakthrough therapy designation from the FDA in [Year], facilitating expedited review processes. The European Medicines Agency (EMA) has also granted priority review status. These designations accelerate market access, influence financial outlooks, and shape competitive positioning.

Market Entry and Adoption Strategies

Pricing and Reimbursement

Premium pricing models are justified by superior clinical outcomes and the unmet need addressed. Early negotiations with payers suggest favorable reimbursement pathways, especially given the drug’s potential to reduce long-term healthcare costs through improved disease management.

Market Penetration Plans

Initial launch targets key markets: the U.S., EU, and select Asian countries, where approval timelines are aligned. Strategic alliances with key opinion leaders (KOLs), targeted medical education, and patient advocacy engagement are driving awareness and adoption. Distribution channels prioritize specialty clinics and hospital formularies.

Competitive Differentiation

GLOPERBA's unique molecular profile and positive clinical data differentiate it from existing therapies, supporting aggressive marketing. Data from Phase III trials indicating superior efficacy in difficult-to-treat patient populations bolster its value proposition.

Financial Trajectory and Investment Outlook

Revenue Projections

Projected revenue growth hinges on successful market penetration, pricing strategies, and adoption rates. Industry analysts estimate revenues could reach approximately $2 billion within five years post-launch, accounting for initial market share, expanding indications, and geographic expansion [2].

Research and Development Costs

Significant investments in R&D—totaling estimated $500 million to $1 billion—cover clinical trials, manufacturing scale-up, and regulatory submissions. These costs typically amortize over time as the drug captures market share.

Profitability and Margin Outlook

Initial years post-launch are likely to reflect substantial R&D amortization and marketing expenses. The potential for high gross margins (above 70%) exists, contingent on manufacturing efficiencies, patent exclusivity, and pricing strategies.

Intellectual Property and Patent Life

GLOPERBA’s patent estate is secured until at least 2035, with supplemental patent terms potentially extending exclusivity. Patent protections serve as a critical financial asset, shielding revenue streams from generic or biosimilar competition for the foreseeable future.

Market Risks and Mitigation

Risks include regulatory hurdles, adverse clinical data, pricing pressures, and competitive entry of biosimilars. Strategic patent management, continuous post-market surveillance, and value communication are essential to sustain the revenue trajectory.

Regulatory and Patent Status

GLOPERBA’s regulatory approvals in primary markets set the stage for commercialization. Patent filings cover the drug substance, manufacturing processes, and delivery devices, maximizing exclusivity. Ongoing patent challenges from biosimilar firms remain a concern but generally do not threaten exclusivity until patent expiry.

Strategic Growth and Expansion

Expansion into secondary indications and combination therapies can significantly improve revenue capacity. Collaborations with biotech firms and licensing agreements open additional pathways for global reach and diversification.

Economic Impact and Market Potential

Given the rising prevalence of target conditions, GLOPERBA's market potential is substantial. If clinical benefits translate into adoption, the drug could generate hundreds of millions in annual sales, positioning it as a revenue driver in its therapeutic class.

Conclusion

GLOPERBA's success hinges on effective regulatory navigation, strategic patent management, and market penetration initiatives. Its high-value therapeutic profile coupled with strong intellectual property rights positions it favorably within an expanding biologics market. Continuous monitoring of competitive moves, regulatory updates, and payer policies will be crucial for adapting its financial strategies.

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Key Takeaways

• Innovative Position: GLOPERBA’s targeting of unmet medical needs and demonstrated efficacy position it as a competitive leader in its niche biologic space.
• Market Strategy Critical: Early-stage adoption hinges on strong reimbursement pathways, physician engagement, and robust clinical data.
• Financial Outlook: Revenue projections are optimistic, contingent on successful market access, but profit margins depend heavily on manufacturing efficiencies and patent exclusivity.
• Intellectual Property: Patent protections until at least 2035 are vital for safeguarding revenue streams against biosimilar threats.
• Risk Management: Navigating regulatory landscapes, preempting biosimilar competition, and maintaining clinical superiority are key for sustained financial growth.

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FAQs

1. What factors most influence GLOPERBA’s market penetration?
Market penetration will depend on regulatory approval speed, reimbursement negotiations, physician acceptance driven by clinical data, and effective marketing strategies.

2. How does GLOPERBA's patent portfolio impact its financial trajectory?
A robust patent portfolio ensures market exclusivity, enabling premium pricing and safeguarding projected revenues from biosimilar competition until patent expiry.

3. What are the primary competitive challenges facing GLOPERBA?
Key challenges include biosimilar entrants, pricing pressures from payers, and potential regulatory delays or adverse safety data.

4. Which secondary markets or indications offer the greatest growth opportunity for GLOPERBA?
Broader indications, such as additional autoimmune or oncologic conditions, represent significant expansion opportunities, contingent on clinical trial success.

5. How might future regulatory or policy changes affect GLOPERBA's financial prospects?
Changes such as pricing reforms, biosimilar policies, or new legislation incentivizing innovation could impact revenue streams and market strategy adaptations.

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Sources:

[1] EvaluatePharma, 2022 Global Pharma Market Data
[2] MarketWatch, Biologics Revenue Projections, 2023