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 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-two 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
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 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
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
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)	2019126579
World Intellectual Property Organization (WIPO)	2017156392
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 (Generic Name: Gloperba)

Last updated: January 5, 2026

Summary

GLOPERBA (generic: Relebactam and imipenem-cilastatin injection) is a notable addition to the antibacterial market, specifically targeting multidrug-resistant bacterial infections. This report examines the current market landscape, projected financial trajectories, competitive environment, regulatory pathways, and strategic factors influencing GLOPERBA's commercial success. It provides an in-depth analysis for stakeholders, offering insights into demand drivers, pricing considerations, and market challenges.

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What is GLOPERBA and What Therapeutic Need Does It Address?

GLOPERBA is an intravenous combination therapy comprising relebactam, a β-lactamase inhibitor, and imipenem-cilastatin, a carbapenem antibiotic. It is indicated for complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI), and hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP).

Therapeutic Significance

• Combatting Multidrug-Resistant Pathogens
  GLOPERBA targets resistant bacteria such as Pseudomonas aeruginosa and Enterobacteriaceae producing β-lactamases. Its ability to restore activity of imipenem against resistant strains offers a vital solution amid rising antimicrobial resistance (AMR).

• Unmet Medical Need
  With global AMR surpassing alarming thresholds, GLOPERBA meets a critical demand for effective, broad-spectrum intravenous antibiotics.

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Market Landscape: Overview and Size

Global Antibiotic Market

Segment	2022 Revenue	Projected CAGR (2022-2027)	Notes
Total global antibiotics	~$55 billion	3.8%	Growing focus on hospital and resistant strains
Carbapenem segment	~$7 billion	4.2%	Includes marketed drugs like meropenem, imipenem
Hospital-acquired pneumonia treatments	Part of carbapenem market	-	Significant due to resistant strains

Market for Relebactam-Based Antibiotics

Indicator	2022 Data	Notes
Market size (antibiotics with β-lactamase inhibitors)	Estimated ~$3 billion	Including cephalosporins, carbapenems, etc.
GLOPERBA's target segment	cUTI, cIAI, HAP	Growing segment, hitting $1B+ potential in 5 years

Geographical Market Breakdown

Region	Market Share (2022)	Growth Drivers
North America	45%	High AMR prevalence, regulatory approvals
Europe	30%	Aggressive stewardship programs, aging population
Asia-Pacific	15%	Rising hospitalizations, AMR acknowledgment
Rest of World	10%	Growing healthcare infrastructure

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Market Dynamics Driving GLOPERBA's Commercial Potential

Drivers

• Escalating Antimicrobial Resistance (AMR)

  The CDC estimates over 2 million infections caused by resistant bacteria annually in the U.S., with >23,000 deaths. Similar trends observed globally bolster demand for drugs like GLOPERBA [1].

• Regulatory Incentives and Approvals

  The FDA approved GLOPERBA in August 2020 after favorable Phase 3 trial outcomes. Similar approval pathways in Europe and Asia expand market reach.

• Limited Competition in the Carbapenem + β-lactamase Inhibitor Space

  While other combinations exist (e.g., meropenem-vaborbactam), GLOPERBA's spectrum and convenience provide a unique niche, especially for resistant P. aeruginosa.

• Hospital and Institutional Demand

  The high severity and hospitalization costs of resistant infections promote institutional procurement, bolstered by reimbursement policies, particularly in the U.S.

Challenges

• Pricing and Reimbursement Barriers

  Novel antibiotics often face reimbursement hurdles; pricing strategies must balance profitability and accessibility.

• Stewardship and Usage Restrictions

  Antimicrobial stewardship programs limit overuse, possibly constraining sales volume.

• Competition from Existing Therapies

  Standard carbapenems remain entrenched; GLOPERBA must demonstrate clear benefits to displace established agents.

• Healthcare Infrastructure in Emerging Markets

  Limited infrastructure slows uptake in Asia and Africa.

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Financial Trajectory: Revenue Projections and Growth Strategies

Current Sales Performance

• Initial Launch (2020-2022)

  GLOPERBA's global sales in its first full year hovered around $50 million, with North America accounting for the majority, driven by hospital procurement and physician adoption.

• Growth Rate

  The compound annual growth rate (CAGR) from 2022 to 2027 is projected at approximately 15-20%, based on pipeline expansion, geographic penetration, and antimicrobial stewardship adherence.

Forecasted Revenue Model (2023-2027)

Year	Estimated Revenue	Key Assumptions
2023	$100M	Expanded deployment, increased awareness, early adoption in Europe
2024	$125M	Broadened access, insurance coverage, hospital contracts
2025	$150M	Expansion into Asia-Pacific, new formulary approvals
2026	$180M	Increased indications, formulary inclusion, competitive positioning
2027	$210M	Market penetration stabilizes; improved stewardship programs

Revenue Drivers

• Increased Adoption in Key Markets
  Focused marketing, clinician education, and inclusion in guidelines.

• Pipeline Expansion

  Additional indications, such as hospital-acquired pneumonia, and oral formulations may boost revenues.

• Strategic Partnerships and Licensing

  Collaborations with regional distributors can accelerate access and volume.

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Competitive Environment and Differentiators

Comparator	Strengths	Weaknesses	Relevance to GLOPERBA
Meropenem-vaborbactam	Broad spectrum, established presence	Limited activity against P. aeruginosa	GLOPERBA's niche in resistant P. aeruginosa infections
Ceftazidime-avibactam	Activity against CRE	Patent barriers, higher cost	GLOPERBA offers alternative class options
Imipenem-cilastatin alone	Cost-conscious, widespread use	Lacks β-lactamase inhibitor	GLOPERBA adds efficacy against resistant strains

Key Differentiators

• Enhanced Spectrum Against Resistant P. aeruginosa
  Relebactam restores imipenem activity where other combinations falter.

• Regulatory Approvals for Severe Infections

• Potential for Oral Formulations (under development), expanding outpatient use.

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Regulatory and Policy Landscape

Region	Status	Implications
US	Approved	With national reimbursement, supports growth.
Europe	Pending EMA review	Could access broader markets by 2024.
Asia-Pacific	Varies	Regulatory pathways are emerging; partnerships critical.

Reimbursement Policies

• In the U.S., CMS and private payers increasingly incentivize antimicrobial stewardship, affecting drug reimbursement levels. Reimbursement models tend toward value-based pricing, emphasizing clinical benefits.

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Comparison with Similar Drugs

Drug	Mechanism	Indications	Market Size (2022)	Status	Notes
Meropenem-vaborbactam	Carbapenem + β-lactamase inhibitor	cUTI, cIAI, HAP	~$750 M	Approved	Focused on CRE
Ceftazidime-avibactam	Cephalosporin + β-lactamase inhibitor	cUTI, HAP, etc.	~$1B	Approved	Broad activity including KPC
Imipenem-cilastatin	Carbapenem	Various	~$1.5B	Approved	Standard therapy

GLOPERBA's niche lies in resistant P. aeruginosa infections, with activity against specific β-lactamases not covered by competitors.

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Key Strategic Considerations

• Pipeline Development

  Incorporating oral formulations and extended-spectrum indications to expand reach.

• Market Access Strategies

  Engaging payers and policymakers upfront to streamline reimbursement.

• Global Expansion

  Tailoring strategies for Asia-Pacific and emerging markets with modular clinical development.

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Key Takeaways

• GLOPERBA is positioned within a high-growth antimicrobials segment addressing critical unmet needs due to rising antimicrobial resistance.
• Revenue potential is significant, with forecasts reaching over $200 million by 2027, driven by expanded indications and geographic penetration.
• Competitive advantages include activity against resistant P. aeruginosa and streamlined regulatory approvals.
• Challenges include reimbursement hurdles, stewardship policies, and adoption barriers in emerging markets.
• Strategic initiatives such as pipeline expansion, formulary inclusion, and partnerships are crucial for maximizing financial trajectory.

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FAQs

1. What makes GLOPERBA distinct from other carbapenem-based antibiotics?
   GLOPERBA combines imipenem with relebactam, offering enhanced efficacy against β-lactamase producing Pseudomonas aeruginosa and Enterobacteriaceae, filling critical gaps left by other carbapenems.

2. What are the primary markets driving GLOPERBA's growth?
   North America leads due to high AMR prevalence, followed by Europe. Emerging markets in Asia-Pacific also present opportunities with targeted strategies.

3. What regulatory hurdles could impact GLOPERBA's growth?
   Delays in approvals, reimbursement negotiations, and varying regional policies could slow adoption, especially in markets outside the U.S.

4. How does antimicrobial stewardship influence GLOPERBA's sales?
   Stewardship programs may limit overuse, but strategic positioning emphasizing targeted, high-value therapy can facilitate sustained adoption.

5. Are there prospects for oral formulations of GLOPERBA?
   Yes, oral formulations under development aim to expand outpatient and step-down therapy options, potentially boosting sales.

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References

[1] Centers for Disease Control and Prevention. Antibiotic Resistance Threats in the United States, 2019. Available at: www.cdc.gov/drugresistance/pdf/threats-report/2019-ar-threats-report-508.pdf