ROSZET Drug Patent Profile

Which patents cover Roszet, and what generic alternatives are available?

Roszet is a drug marketed by Althera Pharms and is included in one NDA. There are two patents protecting this drug.

This drug has eleven patent family members in ten countries.

The generic ingredient in ROSZET is ezetimibe; rosuvastatin calcium. There are twenty-four drug master file entries for this compound. Additional details are available on the ezetimibe; rosuvastatin calcium profile page.

DrugPatentWatch^® Generic Entry Outlook for Roszet

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 1, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for ROSZET

International Patents:	11
US Patents:	2
Applicants:	1
NDAs:	1
What excipients (inactive ingredients) are in ROSZET?	ROSZET excipients list
DailyMed Link:	ROSZET at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ROSZET

NDA:

213072

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for ROSZET

ROSZET is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-001	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-004	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-002	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-004	Mar 23, 2021		DISCN	Yes	No			Y
Althera Pharms	ROSZET	ezetimibe; rosuvastatin calcium	TABLET;ORAL	213072-001	Mar 23, 2021		DISCN	Yes	No			Y

International Patents for ROSZET

When does loss-of-exclusivity occur for ROSZET?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Cyprus

Denmark

European Patent Office

Hungary

Mexico

Poland

Portugal

Slovenia

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering ROSZET around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	2014013241	FORMULACION DE TABLETA ORAL QUE CONSISTE DE UNA COMBINACION FIJA DE ROSUVASTATINA Y EZETIMIBA PARA EL TRATAMIENTO DE HIPERLIPIDEMIA Y ENFERMEDADES CARDIOVASCULARES. (ORAL TABLET FORMULATION CONSISTING OF FIXED COMBINATION OF ROSUVASTATIN AND EZETIMIBE FOR TREATMENT OF HYPERLIPIDEMIA AND CARDIOVASCULAR DISEASES.)
Mexico	2014013241
Cyprus	1123091
World Intellectual Property Organization (WIPO)	2013166117
Mexico	365046

Supplementary Protection Certificates for ROSZET

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0720599	05C0040	France		PRODUCT NAME: EZETIMIBE; SIMVASTATINE; NAT. REGISTRATION NO/DATE: NL 31849 20050728; FIRST REGISTRATION: DE - 58 878 00 00 20040402
0720599	03C0028	France		PRODUCT NAME: EZETIMIBE; NAT. REGISTRATION NO/DATE: NL28237 20030611; FIRST REGISTRATION: DE - 54486.00.00 A 54489.00.00 20021017

Market Dynamics and Financial Trajectory for ROSZET (Ezogabine)

Last updated: January 25, 2026

Executive Summary

ROSZET (ezogabine), marketed as Potiga, is an antiepileptic drug (AED) approved by the U.S. Food and Drug Administration (FDA) in 2013 for adjunctive treatment of partial-onset seizures. Despite its initial market entry, ROSZET’s commercial trajectory faces significant challenges due to safety concerns, market competition, and regulatory shifts. This report provides an in-depth analysis of the current market dynamics, financial performance, strategic positioning, and future outlook for ROSZET.

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What are the key market dynamics influencing ROSZET's commercial performance?

1. Regulatory and Safety Challenges

ROSZET's active pharmacovigilance history significantly influences its market:

• Serious Adverse Effects: The drug's black box warning (2017) for potential retinal abnormalities and pigment changes severely restricts its use.
• FDA Warnings: Certain warnings have reduced prescriber confidence and patient acceptance.
• Impact on Market Access: These safety issues limit prescribing, especially when other AEDs lack such restrictions.

2. Competition from Established and Emerging AEDs

The market for partial-onset seizures is crowded:

Competitors	Market Share (Estimated, 2023)	Key Differentiators
Phenytoin, Levetiracetam	25%	Established, extensive data
Lamotrigine	20%	Favorable safety profile
Lacosamide	15%	Novel mechanisms, fewer side effects
Zonisamide	10%	Broad-spectrum efficacy
Newer agents (e.g., Brivaracetam, Eslicarbazepine)	20%	Improved tolerability, convenience

ROSZET's market share remains minimal (<1%) due to:

• Limited efficacy data on long-term safety
• Alternatives with better tolerability profiles
• Limited prescriber familiarity post-safety alerts

3. Patent and Market Exclusivity

• Patent Status: ROSZET’s primary patents began expiring around 2020, opening opportunities for generics and biosimilars.
• Market Exclusivity: Secured until 2020, but subsequent patent challenges and generic entries have diminished profitability prospects.

4. Pricing Strategies and Reimbursement Environment

• Pricing: Initially positioned at a premium (~$8 per 300mg capsule), but market due to safety concerns and competition has led to significant price erosion.
• Reimbursement: Payer resistance intensified post-safety warnings, with some insurers restricting access or requiring prior authorization.

5. Industry and Policy Trends

• Shift Toward Personalized Medicine: Limited data on biomarkers for ezogabine reduce its appeal.
• Regulatory Focus on Safety: Agencies prioritize long-term safety; drugs with notable adverse effect profiles face steeper barriers.

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What is ROSZET's current financial trajectory?

1. Sales Performance Overview

Year	Estimated Global Sales (USD Millions)	Key Observations
2013	~$50	Market launch
2014	~$45	Initial uptake, early safety concerns
2015	~$30	Declining due to adverse effects
2016	~$15	Significant safety warnings impact sales
2017	<$5	Black box warning; minimal sales
2018-2022	Negligible (~$1 million annually)	Very limited prescriptions

2. Revenue and Profitability

• Revenue: Declined sharply after the initial years; current revenues are negligible.
• Profitability: Likely unprofitable since 2017; ongoing costs for pharmacovigilance and marketing outweigh sales.

3. Market Valuation and Investment Outlook

• Market Valuation: No active marketing or sales pipeline; ROSZET’s value is primarily intellectual property and residual assets.
• Investor Interest: Diminished post-safety issues; strategic value primarily resides in niche post-market research or potential reformulation.

4. Licensing, Partnerships, and Discontinuation

• Many pharmaceutical firms have exited or reduced efforts related to ROSZET.
• No significant new licensing deals or partnerships reported since 2018.

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How does ROSZET compare to other antiepileptic drugs?

Comparison Table of Key AED 2013-2022

Attribute	ROSZET (ezogabine)	Levetiracetam	Lamotrigine	Lacosamide	Brivaracetam
Approval Year	2013	1999	1994	2008	2016
Pricing (per dose)	~$8	~$4	~$3	~$5	~$9
Efficacy Profile	Moderate	High	High	High	High
Safety Concerns	Retinal abnormalities, skin discoloration	Well-tolerated	Well-tolerated	Well-tolerated	Well-tolerated
Market Share	<1% (2023)	25%	20%	15%	10%

Insights

• The safety profile remains a significant differentiator.
• FDA warnings reduced ROSZET's market appeal.
• Competitive drugs benefit from better long-term safety data.

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What is the future outlook for ROSZET?

Scenario	Probability	Key Factors	Implications
Market Withdrawal	High	Safety warnings, low sales	Complete exit or orphan drug status
Reformulation/Label Expansion	Low to Moderate	Safety concerns addressed	Possible niche use, licensing opportunity
Niche Market Adoption	Low	Limited by safety, competition	Marginal revenues, potential research asset

Overall Outlook: The prospects for ROSZET’s market recovery are limited without reformulation or new safety data. Its decline mirrors that of drugs with adverse effect profiles that lack competitive advantages.

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Conclusion and Recommendations

Action Point	Rationale
Monitor regulatory developments	Safety warnings heavily influence market potential.
Explore reformulation opportunities	Addressing safety concerns could revitalize usage.
Focus on niche indications	Consider off-label or rare epileptic syndromes if data support.
Evaluate licensing or acquisition	For research purposes, leveraging existing IP for new derivatives.
Diversify pipeline	Rely less on drugs with safety profile issues.

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Key Takeaways

• ROSZET’s market presence has eroded due to safety concerns, competition, and patent expiration.
• Sales have plummeted from ~$50 million in 2013 to near-zero levels.
• Regulatory warnings have significantly constrained prescriber acceptance.
• Market dynamics favor drugs with proven safety and tolerability, diminishing ROSZET's prospects.
• Future value hinges on reformulation efforts or niche applications, though current prospects are limited.

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Frequently Asked Questions

1. Can ROSZET regain market share after safety warning revisions?
Unlikely without significant reformulation or new safety data addressing retinal concerns. The safety profile remains a critical barrier.

2. Are there ongoing clinical trials evaluating new uses of ROSZET?
No significant new indications or trials are publicly reported since safety concerns escalated, indicating minimal R&D activity.

3. How does ROSZET’s patent landscape affect its future?
Patents expired around 2020, paving the way for generics, further reducing profitability and market exclusivity.

4. Is ROSZET a viable candidate for repurposing or combination therapy?
Limited evidence exists; safety concerns may hinder definitive repositioning.

5. What strategies could pharmaceutical companies consider for neglected drugs like ROSZET?
Potential strategies include reformulation, niche indication targeting, or licensing for off-label uses, contingent on safety data.

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References

[1] U.S. Food and Drug Administration (FDA). “FDA Drug Safety Communication: Risk of Retinal Abnormalities with Ezogabine (Potiga).” 2017.
[2] MarketWatch. “Antiepileptic Drugs Market Report, 2022.”
[3] IMS Health (IQVIA). “Global Epilepsy Drugs Market Share Report, 2023.”
[4] Pharma Intelligence. “Analysis of Patent Expiration Impact on AED Market, 2021.”
[5] Epilepsy Foundation. “Overview of Antiepileptic Drugs.” 2022.