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 four 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:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	113
Clinical Trials:	1
Patent Applications:	1,636
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 four 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			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
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

GLOPERBA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for GLOPERBA®

Introduction to GLOPERBA®

GLOPERBA® is a groundbreaking pharmaceutical product developed by Scilex Holding Company, marking a significant advancement in the treatment of gout. It is the first and only liquid oral formulation of colchicine, specifically designed for the prophylaxis of painful gout flares in adults[1][2][4].

Market Opportunity

The gout treatment market is poised for substantial growth, projected to reach $2.0 billion in the U.S. by 2028. This expansion is driven by the increasing prevalence of gout, affecting an estimated 9.2 million people in the United States. The rising demand for effective treatments presents a lucrative market opportunity for GLOPERBA®[2][4].

Target Population

GLOPERBA® is particularly beneficial for a significant subset of gout patients. Over 70% of gout patients have comorbid conditions that may require dose adjustments, making them an ideal target population for this liquid oral formulation. Additionally, more than 17% of gout patients experience severe gastrointestinal side effects from traditional colchicine tablets, which GLOPERBA® can mitigate through flexible dosing[2][4].

Distribution and Accessibility

Scilex Holding Company has established robust distribution channels, ensuring widespread availability of GLOPERBA®. The product is being stocked in all wholesalers with which Scilex has arrangements throughout the U.S., with the process expected to be completed by June 12, 2024. This extensive distribution network enhances product accessibility and is crucial for quick market uptake[1].

Market Research and Healthcare Professional Interest

Market research conducted among rheumatologists has revealed a high degree of interest in GLOPERBA®. This positive reception from healthcare professionals underscores the product's market viability and potential adoption rate. The unique liquid formulation addresses a specific unmet need, particularly for patients requiring precision dosing and those with gastrointestinal sensitivities[2][3][4].

Pricing Strategy

GLOPERBA® is set to launch with a price of $595 per 150ml bottle, positioning it as a premium product within the gout treatment market. This pricing strategy reflects the product's innovative formulation and the value it brings in terms of patient compliance and reduced side effects[4].

Financial Implications

The introduction of GLOPERBA® is expected to be a revenue catalyst for Scilex Holding Company. Given the company's experience with successful products like ZTlido® and Elyxyb®, Scilex is well-positioned to navigate the market effectively. The financial trajectory for GLOPERBA® is promising, with potential to stabilize earnings and reduce dependence on any single product. Investors should monitor quarterly earnings for signs of revenue growth attributed to GLOPERBA®[1][2].

Competitive Advantage

GLOPERBA® offers several competitive advantages:

• Unique Formulation: It is the first and only liquid oral colchicine formulation, addressing the needs of patients who have difficulty swallowing pills.
• Precision Dosing: The liquid formulation allows for flexible dosing, which is particularly beneficial for patients with comorbid conditions.
• Patient Compliance: Improved compliance is expected due to the ease of administration and reduced gastrointestinal side effects.
• Co-Pay Savings Card: Scilex supports patients with a co-pay savings card, reducing out-of-pocket expenses and enhancing patient adoption[1][2][4].

Regulatory Considerations

Ongoing discussions with the FDA regarding dosing recommendations are critical. Any changes in labeling or usage guidelines could impact market adoption and sales projections. Investors should consider both the commercial potential and regulatory developments when evaluating Scilex's business prospects[2].

Market Penetration and Growth

Scilex's commercial strategy, leveraging its established distribution network and managed care team, is expected to facilitate strong market penetration. The company's past success with other products indicates its ability to effectively market and distribute GLOPERBA®. Long-term success will depend on maintaining a sustainable cost structure and achieving substantial market penetration[1][2].

Patient Benefits

GLOPERBA® addresses several unmet needs in gout treatment:

• Ease of Administration: The liquid formulation is easier to administer, particularly for patients with difficulty swallowing pills.
• Reduced Side Effects: Flexible dosing can mitigate severe gastrointestinal side effects associated with traditional colchicine tablets.
• Precision Dosing: The product allows for precise dosing, which is crucial for patients with comorbid conditions requiring dose adjustments[2][4].

Future Outlook

Scilex Holding Company is well-positioned for continued growth with the introduction of GLOPERBA®. The company's long-term objectives include expanding its non-opioid pain management portfolio and addressing high unmet needs in treating gout. Investors should watch for updates on sales performance and any reported shifts in market dynamics to gauge the product's trajectory and the company's financial performance[2][4].

Key Takeaways

• GLOPERBA® is the first and only liquid oral colchicine formulation for gout flare prophylaxis.
• The gout treatment market is projected to reach $2.0 billion in the U.S. by 2028.
• Over 70% of gout patients have comorbid conditions that may require dose adjustments.
• Scilex has a robust distribution network and a co-pay savings card to support patient adoption.
• The product offers a competitive advantage through its unique formulation and precision dosing.
• Regulatory developments and ongoing market research are crucial for long-term success.

FAQs

What is GLOPERBA® and its significance in gout treatment?

GLOPERBA® is the first and only liquid oral formulation of colchicine, designed for the prophylaxis of painful gout flares in adults. It addresses a specific unmet need, particularly for patients who have difficulty swallowing pills and those requiring precision dosing.

How large is the market opportunity for GLOPERBA®?

The gout treatment market is projected to reach $2.0 billion in the U.S. by 2028, presenting a significant market opportunity for GLOPERBA®.

Who is the target population for GLOPERBA®?

The target population includes over 70% of gout patients who have comorbid conditions that may require dose adjustments, as well as patients experiencing severe gastrointestinal side effects from traditional colchicine tablets.

What is the pricing strategy for GLOPERBA®?

GLOPERBA® is set to launch with a price of $595 per 150ml bottle, positioning it as a premium product within the gout treatment market.

How does Scilex support patient adoption of GLOPERBA®?

Scilex supports patients with a co-pay savings card, reducing out-of-pocket expenses and enhancing patient adoption.

Sources

1. Stocktitan: Scilex Holding Company Announces Stocking of GLOPERBA® is Underway in all of the Wholesalers with which Scilex has Stocking Arrangements Throughout the U.S.
2. Stocktitan: Scilex Holding Company Announces Results from Market Research with Rheumatologists Reveal a High Degree of Interest in GLOPERBA®.
3. Marketscreener: Scilex Holding Company Announces Results from Market Research with Rheumatologists Reveal A High Degree of Interest in GLOPERBA.
4. Biospace: Scilex Holding Company Sets Launch Price of $595 per 150ml Bottle of GLOPERBA, Its First and Only Liquid Oral Version of the Anti-Gout Medicine Colchicine.