Roszet Discontinuation: A Provider Briefing

Roszet (Ezetimibe/Rosuvastatin), the fixed-dose combination tablet manufactured by Althera Life Sciences, has been permanently discontinued. All four formulations — containing Ezetimibe 10 mg paired with Rosuvastatin 5 mg, 10 mg, 20 mg, or 40 mg — are no longer being produced or distributed. This article provides a comprehensive update for clinicians and prescribers managing patients who were taking or would have been prescribed Roszet.

Timeline of Events

• March 2021: FDA approves Roszet (NDA 213072) for primary hyperlipidemia and homozygous familial hypercholesterolemia (HoFH).
• 2022: FDA issues an untitled letter to Althera Life Sciences regarding promotional violations for Roszet marketing materials.
• 2024: Updated labeling (Supplement 004) adds additional drug interaction guidance for darolutamide and regorafenib.
• 2025: All Roszet formulations are discontinued by the manufacturer. No generic combination product is available.

The discontinuation was not preceded by a formal FDA drug shortage listing, as it was a manufacturer-initiated decision rather than a supply disruption.

Prescribing Implications

For patients currently prescribed Roszet, the discontinuation requires a prescription change. Key considerations:

Therapeutic Equivalence

The most straightforward substitution is prescribing the individual generic components separately:

• Generic Rosuvastatin — match the dose the patient was receiving in Roszet (5 mg, 10 mg, 20 mg, or 40 mg)
• Generic Ezetimibe 10 mg — the Ezetimibe component was standardized at 10 mg across all Roszet strengths

This substitution provides pharmacologically identical therapy. Both generic Rosuvastatin and generic Ezetimibe are rated as therapeutically equivalent to their respective brand references (Crestor and Zetia).

Patient Adherence Considerations

The primary clinical advantage of Roszet was the pill burden reduction. Moving from one tablet to two may affect adherence in some patients, particularly those on complex multi-drug regimens. Consider:

• Synchronizing the timing of both generics (both can be taken once daily, with or without food)
• Discussing the switch proactively to set patient expectations
• Using pill organizers or reminder apps for patients with adherence challenges

Dose Adjustment Reminders

When prescribing the separate components, keep in mind the same dose-limiting interactions that applied to Roszet:

• Cyclosporine: Rosuvastatin is contraindicated
• Gemfibrozil: Rosuvastatin is contraindicated
• Darolutamide: Limit Rosuvastatin to 5 mg daily
• Regorafenib: Limit Rosuvastatin to 10 mg daily
• Certain HIV protease inhibitors: Dose modifications per current labeling
• Patients of Asian descent: Consider initiating at Rosuvastatin 5 mg due to increased systemic exposure

For a full drug interaction reference, see our article on Roszet drug interactions.

Current Availability Picture

As of early 2026:

• Brand Roszet: Unavailable. Permanently discontinued. No remaining inventory in distribution.
• Generic Ezetimibe/Rosuvastatin combination: Not available. Patent protections extend to approximately 2033.
• Generic Rosuvastatin: Widely available from multiple manufacturers. No supply concerns.
• Generic Ezetimibe: Widely available from multiple manufacturers. No supply concerns.
• Generic Ezetimibe/Simvastatin (Vytorin generic): Available for patients who may benefit from a single-tablet alternative using a different statin.

Cost and Access Considerations

The switch from brand Roszet to separate generics represents a significant cost reduction for most patients:

Insurance coverage is generally favorable for both generic Rosuvastatin and generic Ezetimibe. Most formularies place them in preferred tiers with low copays. Prior authorization — which was commonly required for brand Roszet — is typically not needed for the generic components.

For patients with financial barriers, coupon programs through GoodRx, SingleCare, and other discount card platforms can reduce out-of-pocket costs further. Patients facing financial hardship can be directed to NeedyMeds or RxAssist for additional support.

Tools and Resources for Providers

Managing medication transitions across a panel of patients can be challenging. Here are tools to streamline the process:

• Medfinder for Providers — Real-time pharmacy availability data to help your patients find medications in stock near them.
• Electronic prescribing alerts: Most EHR systems will flag Roszet as discontinued. Ensure your system is updated to suggest appropriate substitutions.
• Patient handouts: Consider providing patients with a written explanation of why their medication changed and what the new regimen looks like.

For a practical workflow guide on helping patients find medications, see our article on helping patients find Roszet alternatives.

Looking Ahead

The cholesterol treatment landscape continues to evolve. While the loss of Roszet removes one fixed-dose combination option, the underlying therapeutic approach — dual-mechanism LDL lowering with a statin plus Ezetimibe — remains well-supported by evidence (IMPROVE-IT trial data and subsequent guidelines).

A generic Ezetimibe/Rosuvastatin combination tablet may eventually reach the market after patent expiry (estimated 2033), but this is speculative. In the meantime, the separate generic components provide effective, affordable, and widely accessible therapy.

Newer lipid-lowering agents, including PCSK9 inhibitors (Repatha, Praluent) and Bempedoic acid (Nexletol), may be appropriate for patients who cannot achieve target LDL levels with statin/Ezetimibe therapy alone.

Final Thoughts

The Roszet discontinuation is a straightforward transition for most practices. The key action items are:

1. Identify patients currently prescribed Roszet
2. Write new prescriptions for generic Rosuvastatin (matched dose) + generic Ezetimibe 10 mg
3. Communicate the change proactively to patients
4. Schedule follow-up lipid panels in 4-8 weeks
5. Direct patients to Medfinder for Providers for pharmacy availability support

The therapeutic impact on your patients should be minimal, and many will benefit from lower out-of-pocket costs with the generic switch.