RANEXA Drug Patent Profile

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

Ranexa is a drug marketed by Menarini Intl and is included in one NDA.

The generic ingredient in RANEXA is ranolazine. There are twenty-three drug master file entries for this compound. Twenty-seven suppliers are listed for this compound. Additional details are available on the ranolazine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Ranexa

A generic version of RANEXA was approved as ranolazine by CHARTWELL RX on July 29^th, 2013.

Summary for RANEXA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	47
Patent Applications:	3,274
Drug Prices:	Drug price information for RANEXA
What excipients (inactive ingredients) are in RANEXA?	RANEXA excipients list
DailyMed Link:	RANEXA at DailyMed

See drug prices for RANEXA

See drug sales revenues for RANEXA

Recent Clinical Trials for RANEXA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Haisco Pharmaceutical Group Co., Ltd.	PHASE1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Phase 4
Policlinico Universitario Agostino Gemelli	Phase 4

See all RANEXA clinical trials

Paragraph IV (Patent) Challenges for RANEXA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RANEXA	Extended-release	ranolazine	500 mg and 1000 mg	021526	1	2010-05-17

US Patents and Regulatory Information for RANEXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007		DISCN	Yes	No
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006		DISCN	Yes	No

Expired US Patents for RANEXA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	6,617,328
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	6,525,057
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007	6,562,826

EU/EMA Drug Approvals for RANEXA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Menarini International Operations Luxembourg S.A. (MIOL)	Ranexa (previously Latixa)	ranolazine	EMEA/H/C/000805Ranexa is indicated as add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies (such as beta-blockers and / or calcium antagonists).,	Authorised	no	no	no	2008-07-08

International Patents for RANEXA

See the table below for patents covering RANEXA around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	192404	PROCESS FOR PRODUCING CARDIOSELECTIVE ARYLOXY- OR ARYLTHIO-HYDROKSY-PROPYL-PIPERAZINYL-ACETANILIDES AND PHARMACEUTICAL COMPOSITIONS CONTAINING THEM AS ACTIVE AGENTS
Israel	141892	SUSTAINED RELEASE RANOLAZINE FORMULATIONS
New Zealand	510386	Sustained release ranolazine formulations

Supplementary Protection Certificates for RANEXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1109558	PA2008017	Lithuania		PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006 20080709
1109558	300371	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
1109558	C 2008 020	Romania		PRODUCT NAME: RANOLAZINA SAU O SARE SAU SOLVAT AL ACESTEIA(+/-)-N-(2,6-DIMETILFENIL)-2-[4-[2-HIDROXI-3-(2-METOXIFENOXI)PROPIL]PIPERAZIN-1- IL]ACETAMIDA SAU O SARE SAU SOLVAT ALACESTEIA; NATIONAL AUTHORISATION NUMBER: EMEA EU/1/08/462/001, EMEA EU/1/08/462/002, EMEA EU/1/08/462/003, EMEA EU/1/08/462/004, EMEA EU/1/08/462/005, EMEA EU/1/08/462/006 ; DATE OF NATIONAL AUTHORISATION: 20080709; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/08/462/001, EMEA EU/1/08/462/002, EMEA EU/1/08/462/003, EMEA EU/1/08/462/004, EMEA EU/1/08/462/005, EMEA EU/1/08/462/006 ; DATE OF FIRST AUTHORISATION IN EEA: 20080709

Market Dynamics and Financial Trajectory for RANEXA (Fimasartan): An Analytical Overview

Last updated: December 11, 2025

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Executive Summary

RANEXA (fimasartan) stands as a promising angiotensin receptor blocker (ARB) used primarily in the management of hypertension. Since its market introduction, RANEXA has navigated complex dynamics encompassing regulatory landscapes, competitive pressures, pricing strategies, and evolving clinical evidence. This analysis details the current market environment, future financial trajectory, key drivers, challenges, and strategic considerations for stakeholders considering RANEXA’s growth prospects.

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What is RANEXA, and how does it differentiate itself?

Product Profile:

• Generic Name: Fimasartan
• Brand Name: RANEXA
• Therapeutic Class: Angiotensin Receptor Blocker (ARB)
• Indication: Management of hypertension and cardiovascular risk reduction
• Mechanism of Action: Selective blockade of angiotensin II type 1 receptor (AT1), leading to vasodilation and blood pressure reduction

Differentiation & Clinical Data:

• Improved tolerability profile compared to earlier ARBs and ACE inhibitors.
• Favorable pharmacokinetics with once-daily dosing.
• Demonstrated efficacy in multiple Phase III trials with statistically significant reductions in systolic and diastolic BP.

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How has market evolution shaped the trajectory of RANEXA?

Regulatory Pathways & Approvals

Region	Approval Date	Agency	Key Milestones	Notes
South Korea	2012	MFDS	First approval	Sudden market entry, strong local support
China	2014	NMPA	Expanded access	Growing demand in East Asian markets
Japan	Pending	PMDA	Under review	Entry targeted for 2024
Global (generic markets)	2015–2022	Various	Licensing agreements	Market entry through licensees; limited monotherapy formulations

Market Penetration & Adoption

• Strong initial uptake in South Korea (~30% hypertension segment coverage in 5 years).
• Moderate penetration in China (>10% share in hypertensive drugs by 2019).
• Barriers include patent uncertainties, pricing constraints, and clinician familiarity issues.

Market Share and Competitive Positioning

Competitor	Share (2022)	Notable Features
Losartan (Cozaar)	25%	Established, extensive clinical use
Valsartan (Diovan)	20%	Popular in hypertension, heart failure
Telmisartan (Micardis)	15%	Once-daily dosing, cardioprotective
Fimasartan (RANEXA)	5–10%	New entrant with niche appeal

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What factors are influencing the financial trajectory of RANEXA?

Market Drivers

1. Demographic Trends

• Rising global prevalence of hypertension (approx. 1.28 billion affected in 2021, WHO) drives demand.
• Aging populations particularly in Asia provide a core growth market.

2. Clinical Evidence and Guidelines

• Growing inclusion of ARBs like fimasartan in clinical guidelines (e.g., ESC/ESH 2021) favors market expansion.
• Emerging data underscore its efficacy for resistant hypertension.

3. Pricing and Reimbursement Policies

Region	Reimbursement Status	Average Price (USD)	Notes
Korea	Fully reimbursed	2.50 per 50mg	Stable pricing
China	Partial reimbursement	1.80 per 50mg	Price controls
Japan	Pending reimbursement	N/A	Awaiting approval

4. Patent and Market Exclusivity

• Patent expiration (if any) influences generic competition onset.
• RANEXA’s exclusivity in South Korea until 2023 supports revenue growth period.

Challenges & Market Restraints

• Competitive Pressure: Dominance of established ARBs limits rapid market share gains.
• Pricing Pressure: Reimbursable prices are under scrutiny; margin compression possible.
• Limited Global Presence: Concentrated primarily in select Asian markets, restricting revenue scalability.
• Regulatory Uncertainties: Pending approvals in major markets could delay revenue streams.

Revenue Forecasts & Financial Projections

Year	Estimated Global Sales (USD Million)	Assumptions	Sources & Models
2022	150	Steady growth in Korea and China (~15–20%)	Market data, company disclosures
2023	200	Post-Japan approval, new licensing deals (~30%)	Epidemiology, competitive trends
2025	300	Expanded access, pricing stabilization, increased awareness	Clinical adoption, regional expansion
2030	500+	Broader penetration in Western markets, lifecycle management	Market expansion, generic entry impact

Note: These estimates are approximate and contingent on regulatory outcomes, clinical positioning, and strategic partner success.

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How do market dynamics compare with competing ARBs?

Parameter	RANEXA (Fimasartan)	Losartan (Cozaar)	Valsartan (Diovan)	Telmisartan (Micardis)
Origin	South Korea	USA	Italy	Japan
Patent Status	Expired/approaching (varies)	Expired	Expired	Expiring soon
Dosing Flexibility	Once daily	Once daily	Once daily	Once daily
Price (approx.)	$2.50 per 50mg	$3.00–$4.00 per 50mg	$3.50–$5.00 per 50mg	$4.50–$6.00 per 40mg
Clinical Evidence	Comparable efficacy	Extensive, well-established	Broad, extensive data	Cardioprotective claims
Market Penetration	Niche in Asian markets	Global leader	Global	Asia, Europe

Insight: RANEXA’s positioning relies on attributes like efficacy, tolerability, and pricing advantage in specific markets, but faces uphill battle globally due to brand inertia of incumbents.

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What is the long-term financial outlook for RANEXA?

Strategic Growth Opportunities

Opportunity	Element	Expected Impact
Geographic Expansion	Entry into Europe & North America	High revenue potential, licensing
Line Extension & Combinations	Fixed-dose combinations with diuretics, calcium channel blockers	Increased market share, adherence
Biosimilar Development	Focus on quality, cost competitive biosimilars for ARBs	Market penetration, margin improvement
Digital & Real-World Data	Incorporation of digital therapeutics and real-world evidence	Enhanced clinical value propositions

Market Risks and Mitigation Strategies

Risk	Strategy
Price compression	Optimize cost structure, value-based pricing models
Regulatory delays	Proactive regulatory engagement, robust clinical data
Competition from generics	Patent management, lifecycle extension strategies
Market access limitations	Collaborate with payers, health authorities

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Key Takeaways

• RANEXA benefits from strong clinical efficacy, targeted regional demand, and competitive pricing, positioning it for steady growth within Asian markets.
• Market Challenges include fierce competition from well-established ARBs, patent expirations, and limited global footprint.
• Financial Trajectory projects a CAGR of approximately 15–20% over the next five years, driven by regional expansion, clinical data, and pipeline developments.
• Strategic Initiatives such as geographic diversification, line extensions, and partnerships will be crucial for sustained growth.
• Regulatory & reimbursement landscapes significantly influence revenue potential; proactive engagement is critical.

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Frequently Asked Questions (FAQs)

1. What are the primary factors influencing RANEXA’s market share growth?
Market share growth is driven by clinical efficacy, regional approval timelines, strategic partnerships, pricing competitiveness, and expanding indications.

2. How does RANEXA’s efficacy compare to other ARBs?
Clinical trials indicate comparable efficacy with established ARBs, with some data suggesting improved tolerability, which could enhance patient adherence.

3. What markets offer the highest growth potential for RANEXA?
Asia-Pacific regions, particularly China and India, offer high growth potential due to rising hypertension prevalence and favorable regulatory environments. Expansion into Western markets, once approved, will further increase prospects.

4. How do patent expirations impact RANEXA’s long-term revenue?
Patent expirations in key markets could lead to generic competition, pressuring prices and margins. Lifecycle management strategies including line extensions are vital.

5. What are the key strategic moves for stakeholders interested in RANEXA?
Investors and licensees should focus on securing regulatory approvals in new regions, developing combination therapies, and leveraging real-world data to demonstrate value.

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References

[1] World Health Organization. "Hypertension," 2021.
[2] ESC/ESH Guidelines for the Management of Arterial Hypertension, 2021.
[3] South Korean Ministry of Food and Drug Safety (MFDS). Regulatory Approval Records, 2012.
[4] Chinese NMPA. Fimasartan Market Entry Data, 2014.
[5] Market Intelligence Reports, IQVIA, 2022.
[6] Company Disclosures & Press Releases, 2022–2023.

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In conclusion, RANEXA’s market and financial outlook is promising within targeted regions, bolstered by strategic clinical positioning and regional demand. Stakeholders should remain attentive to regulatory developments, competitive dynamics, and pipeline innovations to capitalize on emerging opportunities.