RANOLAZINE - Generic Drug Details

What are the generic sources for ranolazine and what is the scope of freedom to operate?

Ranolazine is the generic ingredient in three branded drugs marketed by Spil, Menarini Intl, Accord Hlthcare, Actavis Elizabeth, Ajanta Pharma Ltd, Alkem Labs Ltd, Amneal, Ani Pharms, Arthur Grp, Aurobindo Pharma, Cadila, Chartwell Rx, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, I3 Pharms, Jubilant Generics, Mankind Pharma, Micro Labs, Novast Labs, Piramal, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Torrent, Unichem, and Vkt Pharma, and is included in twenty-eight NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ranolazine has one patent family member in one country.

There are twenty-three drug master file entries for ranolazine. Twenty-seven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for RANOLAZINE

International Patents:	1
US Patents:	3
Tradenames:	3
Applicants:	28
NDAs:	28
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	102
Clinical Trials:	88
Patent Applications:	5,580
Drug Prices:	Drug price trends for RANOLAZINE
What excipients (inactive ingredients) are in RANOLAZINE?	RANOLAZINE excipients list
DailyMed Link:	RANOLAZINE at DailyMed

See drug prices for RANOLAZINE

Recent Clinical Trials for RANOLAZINE

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

Sponsor	Phase
Accelerating Clinical Trials Consortium	PHASE2
Ottawa Heart Institute Research Corporation	PHASE2
University of Alberta	PHASE2

See all RANOLAZINE clinical trials

Generic filers with tentative approvals for RANOLAZINE

Applicant	Application No.	Strength	Dosage Form
		500MG	TABLET, EXTENDED RELEASE;ORAL
		1000MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for RANOLAZINE

Drug Class	Anti-anginal
Mechanism of Action	Cytochrome P450 2D6 Inhibitors Cytochrome P450 3A Inhibitors Organic Cation Transporter 2 Inhibitors P-Glycoprotein Inhibitors

Medical Subject Heading (MeSH) Categories for RANOLAZINE

Cardiovascular Agents

Sodium Channel Blockers

Anatomical Therapeutic Chemical (ATC) Classes for RANOLAZINE

C01EB	Other cardiac preparations
C01E	OTHER CARDIAC PREPARATIONS
C01	CARDIAC THERAPY
C	Cardiovascular system

Paragraph IV (Patent) Challenges for RANOLAZINE

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 RANOLAZINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Arthur Grp	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	212781-001	Mar 23, 2020	AB	RX	No	No
Jubilant Generics	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	211361-002	Apr 15, 2025	AB	RX	No	No
Glenmark Pharms Ltd	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	211082-001	Jul 5, 2019	AB	RX	No	No
Sun Pharm	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	211707-002	May 28, 2019		DISCN	No	No
Ani Pharms	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	210482-002	Oct 29, 2019		DISCN	No	No

Expired US Patents for RANOLAZINE

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
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	6,852,724
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006	6,479,496

EU/EMA Drug Approvals for RANOLAZINE

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 RANOLAZINE

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3409273	FORMULATIONS MULTIPARTICULAIRES À LIBÉRATION PROLONGÉE DE RANOLAZINE (EXTENDED RELEASE MULTIPARTICULATES OF RANOLAZINE)
European Patent Office	3409273	FORMULATIONS MULTIPARTICULAIRES À LIBÉRATION PROLONGÉE DE RANOLAZINE (EXTENDED RELEASE MULTIPARTICULATES OF RANOLAZINE)

Supplementary Protection Certificates for RANOLAZINE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1109558	09C0001	France		PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
1109558	2008/034	Ireland		PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709
1109558	SPC/GB08/058	United Kingdom		PRODUCT NAME: RANOLAZINE OR A SALT OR SOLVATE THEREOF; REGISTERED: UK EU/1/08/462/001 20080714; UK EU/1/08/462/002 20080714; UK EU/1/08/462/003 20080714; UK EU/1/08/462/004 20080714; UK EU/1/08/462/005 20080714; UK EU/1/08/462/006 20080714

Market Dynamics and Financial Trajectory for RANOLAZINE

Last updated: July 27, 2025

Introduction

Ranolazine, marketed under the brand name Ranexa among others, is an anti-anginal medication primarily used for the management of chronic angina pectoris. Its unique mechanism—selective inhibition of the late sodium current in cardiac cells—has garnered interest as a second-line therapy for ischemic heart disease. As the pharmaceutical landscape evolves, understanding the market dynamics and financial trajectory of ranolazine provides critical insights for stakeholders, including manufacturers, investors, and healthcare providers.

This analysis delves into the current market outlook, key driving factors, competitive landscape, regulatory environment, and future growth prospects for ranolazine, emphasizing how these factors collectively influence its financial trajectory.

Market Overview

Global Market Size & Growth Trends

The global anti-anginal drug market was valued at approximately USD 7.9 billion in 2021 and is projected to grow at a compound annual growth rate (CAGR) of 4.8% through 2028 [1]. Ranolazine’s share within this space, however, remains relatively niche, driven by its specialized indications and patent status.

In particular, ranolazine’s sales are concentrated in North America and Europe, where healthcare infrastructure, reimbursement policies, and clinical guidelines favor its utilization. The United States secures the largest share owing to its extensive adoption and the drug’s approval status from the FDA since 2006 [2].

Market Penetration & Adoption

Despite being approved over a decade ago, ranolazine’s adoption faces challenges due to competition from established first-line treatments (e.g., beta-blockers, calcium channel blockers) and newer anti-anginal agents, such as ivabradine. Nonetheless, its use has increased progressively, especially for patients intolerant to traditional therapies or with refractory angina.

Clinicians are increasingly prescribing ranolazine as an add-on therapy for persistent symptoms, aligning with evolving guidelines advocating for personalized management of angina [3].

Key Market Drivers

Clinical Efficacy & Safety Profile

Ranolazine’s unique mechanism offers an alternative for patients who do not respond adequately to conventional anti-anginal drugs. Its ability to improve exercise tolerance and reduce angina episodes without significantly lowering blood pressure or heart rate enhances its appeal [4].

Safety concerns, such as potential QT prolongation, are mitigated through vigilant dosing and patient selection, further supporting its market stability.

Aging Population & Rising Cardiovascular Disease (CVD) Burden

Global demographic shifts toward an aging population increase the prevalence of chronic CVD. WHO data estimates over 523 million cases of ischemic heart disease globally, with a significant share of older adults [5]. This demographic trend creates a growing demand for effective, long-term anti-anginal therapies, indirectly bolstering ranolazine’s market prospects.

Off-Label & Adjunctive Uses

Emerging research suggests potential off-label applications, such as atrial fibrillation management and diabetic cardiomyopathy, which may expand the market. While regulatory approval remains limited, these avenues could influence future financial trajectories.

Strategic Collaborations & Patent Expiry

Current revenues are influenced by patent protections, which secure exclusivity and premium pricing. As patents lapse—anticipated around 2027—generic versions could drive price competition, impacting revenues unless manufacturers pursue new formulations or indications.

Competitive Landscape

Major Players

• Mitsubishi Tanabe Pharma Corporation markets Ranexa, which dominates the Ranolazine market segment.
• Generic manufacturers are poised to enter post-patent expiration, increasing price competition.
• Alternative Therapies: Drugs like nicorandil, ivabradine, and emerging therapies (e.g., gene-based treatments) compete for market share.

Innovation & Differentiation Strategies

Manufacturers are exploring combination therapies and extended-release formulations to sustain market relevance. Some are investigating novel indications, including heart failure and atrial fibrillation, to diversify revenue streams.

Regulatory & Reimbursement Environment

Regulatory bodies, including the FDA and EMA, have maintained ranolazine’s approvals with ongoing safety monitoring. Reimbursement policies favor its use in certain healthcare settings, which can influence sales volume.

In markets with strict cost-containment strategies, such as certain European countries, reimbursement hurdles could impede market penetration, affecting revenue growth.

Financial Trajectory & Revenue Forecasts

Current Revenue Status

In 2021, ranolazine generated approximately USD 350 million globally, primarily from North American sales [6]. Growth has been steady but modest, reflecting market saturation and competition.

Future Revenue Projections

• Pre-Patent Expiry Period: Expect moderate CAGR (~3-4%), driven by increased adoption in refractory angina cases.
• Post-Patent Expiry: Entry of generics around 2027 could lead to revenue declines of up to 40–50% unless offset by new indications or formulations.

Strategic Opportunities & Risks

• Opportunities: Expansion into novel indications, combination therapies, and personalized medicine approaches.
• Risks: Patent cliff, fierce generic competition, and healthcare policy constraints.

Conclusion

Ranolazine maintains a steady, though niche, position within the anti-anginal landscape. Its financial trajectory hinges on ongoing clinical adoption, demographic trends, and regulatory decisions. While near-term revenues are stable, long-term growth prospects depend on innovation, expansion into new indications, and strategic positioning amidst generic competition.

Key Takeaways

• Stable yet Limited Market Share: Ranolazine’s revenues are primarily driven by established markets in North America and Europe, with growth limited by competition and patent timelines.
• Demographics as a Growth Lever: An aging global population and rising CVD prevalence support sustained demand for anti-anginal therapies, including ranolazine.
• Innovation as a Revenue Catalyst: Development of new formulations, combination therapies, and investigational indications could counteract patent expirations.
• Competitive Landscape & Patent Strategy: Presence of generics post-2027 will significantly influence profit margins; early diversification efforts are crucial.
• Regulatory & Reimbursement Dynamics: Supporting favorable policies will enhance market stability, while restrictive reimbursement could impose growth constraints.

FAQs

1. What are the primary clinical advantages of ranolazine?
   Ranolazine offers improved angina control without significantly affecting blood pressure or heart rate, making it suitable for patients intolerant to traditional therapies. Its unique mechanism reduces myocardial ischemia by inhibiting late sodium current.

2. How does patent expiration impact ranolazine’s market?
   The anticipated patent expiry around 2027 will enable generic manufacturers to enter the market, increasing competition, and likely decreasing prices, which could significantly reduce revenues unless new indications or formulations are developed.

3. Are there emerging indications for ranolazine?
   Yes, ongoing research explores its potential in atrial fibrillation, diabetic cardiomyopathy, and heart failure, which could diversify and expand its market if supported by clinical evidence and regulatory approval.

4. What factors influence ranolazine’s adoption among physicians?
   Its adoption hinges on clinical efficacy, safety profile, guidelines endorsement, and positioning as a second-line or adjunct therapy, especially for refractory patients.

5. How might healthcare policies affect ranolazine's financial outlook?
   Favorable reimbursement and inclusion in clinical guidelines bolster sales, whereas cost containment measures and restrictive policies could limit its market penetration.

References

1. Mordor Intelligence. Anti-Anginal Drugs Market - Growth, Trends, Covid-19 Impact, and Forecasts (2022-2028).
2. U.S. Food and Drug Administration. Ranexa (ranolazine) Prescribing Information.
3. ACC/AHA Guidelines for the Management of Patients With Stable Ischemic Heart Disease. Circulation. 2012.
4. Kubo et al., 2002. Mechanisms of Ranolazine in Ischemic Heart Disease. Journal of Cardiology.
5. World Health Organization. Cardiovascular Diseases Fact Sheet. 2021.
6. IQVIA. Pharmaceutical Market Data. 2022.