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

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
Cyprus	1123091
Denmark	2844233
European Patent Office	2844233

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

Last updated: July 27, 2026

ROSZET (rosuvastatin + ezetimibe) Market Dynamics and Financial Trajectory: Pricing, Uptake, Competition, and Exclusivity Risks

Executive summary: ROSZET (rosuvastatin/ezetimibe) is a branded fixed-dose combination in the cholesterol-lowering market competing against generic statins, generic ezetimibe, and multiple branded combination regimens. Its financial trajectory is shaped by (1) patent and regulatory exclusivity timing for the combination and specific formulations, (2) rapid payer preference for low-cost generics and step-therapy, (3) competitor mix (other statin/ezetimibe products, PCSK9 inhibitors, and LDL-C adjuncts), and (4) NDC-level contracting and utilization trends driven by commercial coverage policies.

The following sections map ROSZET market forces and the likely revenue path by linking competitive positioning to exclusivity and payer economics, then outlining generic/therapeutic substitution risk points that affect near- and medium-term financial outcomes.

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What is ROSZET and how is it positioned versus generic statins and ezetimibe?

ROSZET is a fixed-dose combination of rosuvastatin and ezetimibe, targeting LDL-C reduction in patients with hyperlipidemia and related dyslipidemia indications. In practice, ROSZET is used where clinicians want the efficacy of combining a statin with intestinal cholesterol absorption inhibition rather than titrating monotherapy.

Market positioning logic

• Clinical value proposition: higher LDL-C reductions than statin monotherapy at comparable tolerability compared with up-titrating statin alone.
• Formulary value proposition: may replace two separate prescriptions (statin + ezetimibe) when payers allow combination products.
• Budget pressure: payers often prefer separate generics if they are both available at low cost, which compresses combination-product economics unless ROSZET is contractually placed on preferred tiers.

Featured snippet answer (positioning): ROSZET competes primarily on payer coverage and copay/coinsurance mechanics against separate generic rosuvastatin and ezetimibe, and against other lipid-lowering branded regimens that can win high-need patients under specialty or restricted formularies.

How do payer policies affect ROSZET uptake?

Commercial coverage tends to drive volume more than clinical differentiation because:

• Step therapy is common for lipid-lowering drugs, especially for brand combination products.
• Formulary tiering often places combinations below preferred generics unless a value-based or rebates structure improves net pricing.
• Prior authorization frequently targets “clinical necessity” language such as failure or inadequate response to monotherapy.

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How is ROSZET pricing structured and what determines net revenue versus list price?

Financial trajectory for a branded combination depends on net price, not list price, because rebates, discounts, and contracting dominate in lipid categories.

Key net revenue drivers

• Payer mix: commercial versus Medicare Part D mix changes average discounts and copay behavior.
• Formulary placement: preferred vs non-preferred tiers can swing volume materially.
• PBM contracting strategy: bundled or class-based rebates can determine whether ROSZET displaces separate generics or stays a niche add-on.
• Patient cost sharing: even modest copay differences can change persistence and early adoption.

What contracts and reimbursement dynamics most impact ROSZET financial performance?

1. Net-to-brutal ratio sensitivity: combination products often face sharper rebate pressure when two components are available generically.
2. Utilization controls: payers can steer use toward lower-cost alternatives via step therapy or quantity limits.
3. 340B and institutional pricing: may affect certain channels and revenue recognition patterns.

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When does ROSZET lose exclusivity and how does that shape revenue decline timing?

Revenue decline timing is determined by:

• Patent expiry covering the drug substance, composition, and combination-specific claims.
• Regulatory exclusivity (if any) tied to the approved product and NDA/BLA timeline.
• Switch potential once FDA approval pathways allow generic entry, including authorized generics where applicable.

Featured snippet answer (timing): ROSZET’s revenue profile typically follows a late-peak plateau during the final period before patent or exclusivity loss, then a step-down after first generic or AB-rated competition enters the market.

What generic entry risks exist for ROSZET?

Generic entry risk depends on whether competitors can:

• Demonstrate bioequivalence with the fixed-dose combo, and
• Carve out patent-covered formulation or method-of-use elements, and
• Launch quickly after exclusivity ends, subject to patent litigation status.

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What patent estate supports ROSZET and how strong is it against generic and biosimilar-style design-arounds?

ROSZET’s competitive durability depends on the depth of its patent estate, typically spanning:

• composition of matter for each component and combination,
• formulation specifics (fixed-dose tablet composition, dissolution/particle-size-related aspects if claimed),
• methods of treatment, and
• manufacturing-related process claims.

Featured snippet answer (patent strength): Fixed-dose combination products can have higher barriers than single-ingredient generics because formulation and combination-specific claims may block direct ANDA launches or create settlement leverage.

How do formulation and method-of-use patents affect Android launch timing?

• Composition/formulation claims can drive first-filing ANDA patent litigation and settlement timing.
• Method-of-use claims can limit “skinny labeling” or force generics to avoid specific patient subsets or dosing regimens.

How many patent families typically cover combination products like ROSZET?

Combination products in lipid space often have multiple patent families across:

• active ingredient claims,
• salt/polymorph or particle-size,
• composition and dosage form,
• and clinical claims.

The practical question for revenue is whether competitors can file an ANDA with a “no infringement” theory or design around without losing approval speed.

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Has ROSZET faced Paragraph IV challenges, ANDA litigation, or settlement agreements?

Paragraph IV challenges and settlements are the most direct legal-to-financial link for brand revenue.

Featured snippet answer (legal-to-revenue): If ROSZET has an ANDA Paragraph IV history, the most important financial milestones are the first court decision date, settlement effective date, and any agreed “launch protection” period.

What litigation events typically shift ROSZET financial trajectory?

• loss of preliminary injunctions that permit potential launch,
• trial outcomes that narrow the remaining injunction window,
• and settlements that convert patent risk into a defined “at-risk” launch calendar.

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What is the Orange Book status of ROSZET and which patents are listed?

Orange Book listings define the “hard” patent landscape for ANDA applicants. For revenue planning, the critical elements are:

• which patents are listed for the drug product, and
• their statutory expiration dates, plus
• whether exclusivity blocks approvals.

Featured snippet answer (Orange Book): The Orange Book “drug product” and “active ingredient” patent categories set the earliest realistic generic entry window and govern whether a competitor can launch at approval.

How do Orange Book patent types influence generic launch likelihood?

• patents expiring on or near the same dates can create cluster risk,
• formulation patents can allow generic entry but with label limits,
• method-of-use can prevent full label parity.

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How does ROSZET compare commercially with other statin/ezetimibe combinations?

ROSZET competes against the broader statin/ezetimibe and LDL-C adjunct landscape. Commercial differentiation is typically less about molecular novelty and more about:

• formulary access,
• clinician switching patterns,
• and payer-driven utilization.

Featured snippet answer (competitive comparison): ROSZET’s unit growth is constrained by the availability of generic statin + generic ezetimibe and by formulary preference for the lowest net cost per LDL-C reduction.

What competitor classes most affect ROSZET revenue?

• other fixed-dose statin/ezetimibe brands,
• generic statin + generic ezetimibe (most direct cost substitute),
• PCSK9 inhibitors for high-risk patients under restrictive criteria,
• bempedoic acid, bile acid sequestrants, and other adjuncts for specific tolerability profiles.

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What does ROSZET’s competitive landscape imply for future volume and persistence?

In lipid therapy, persistence depends on:

• tolerability (statin-associated adverse events are a key driver),
• achieving LDL-C targets (which drives adherence),
• and payer friction (prior authorization, step therapy, copay).

Featured snippet answer (volume/persistence): ROSZET volume growth is most likely to come from incremental combination adoption where payers grant favorable coverage, while persistence is sensitive to copay and step-therapy relabeling.

Where do brands typically lose share first in lipid combination categories?

• after generic combination components achieve broad low-cost access,
• when PBMs broaden preferred tiers for generics,
• and when clinical guidelines shift toward adjunct sequences that reduce use of generic-host combination products.

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How do exclusivity and patent expiry translate into a generic launch scenario for ROSZET?

A realistic generic launch scenario in fixed-dose combinations includes:

1. ANDA approval date after exclusivity/patent blocking windows clear,
2. first commercial generic entry by the first labeler,
3. post-approval substitution driven by pharmacy benefits manager switching tools,
4. rebate renegotiation by the brand to preserve share.

Featured snippet answer (launch scenario): Revenue typically declines in a stepwise pattern, with the largest drop after first generic entry and further reductions as multiple AB-rated products reach pharmacy channels.

What revenue-mitigation levers can brands use before and after entry?

• contract strategy improvements (higher rebates for preferred tier retention),
• expanding patient segments on-label,
• and introducing line extensions or new dosage forms if protected.

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What FDA and regulatory milestones matter most for ROSZET financial trajectory?

Regulatory milestones that affect revenue include:

• approval timing (initial ramp),
• label expansion events that broaden eligible patient populations,
• and any regulatory actions that alter manufacturing or supply.

Featured snippet answer (regulatory-to-financial): label expansion and supply continuity typically move revenue; regulatory constraints can delay adoption and force formulary setbacks.

Which FDA pathway features influence competition?

• whether the product is protected as a specific NDA drug product with listed patents,
• and whether future labeling changes reopen competition risk windows.

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Key Takeaways

• ROSZET’s financial path is governed less by therapeutic differentiation and more by payer economics, formulary access, and the ability to sustain net pricing against generic rosuvastatin + generic ezetimibe.
• Revenue durability depends on how many combination-specific patents remain enforceable and how litigation shapes “protected launch” dates.
• The most consequential financial inflection points are exclusivity/patent loss and subsequent generic entry, which typically produce stepwise revenue declines as AB-rated alternatives take pharmacy shelf share.
• Competitive pressure is persistent because the components are often available generically, pushing branded fixed-dose combinations into payer negotiation dependence.

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FAQs

1. How do prior authorization and step therapy typically change ROSZET adoption compared with generic rosuvastatin plus ezetimibe?
2. What do Orange Book patent expiration clusters usually mean for ROSZET generic launch risk?
3. How does a first generic entrant versus multi-entrant timing affect ROSZET revenue decline shape?
4. What label expansion events for lipid combination products most improve long-term persistence?
5. How do PCSK9 inhibitors and other LDL-C adjunct therapies reduce the pool for statin/ezetimibe combinations like ROSZET?

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References (APA)

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/ (accessed 2026-07-27)