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, Allied, Amneal, Ani Pharms, Aurobindo Pharma, Cadila, Chartwell Rx, Cipla, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Mankind Pharma, Micro Labs, Novast Labs, Piramal, Praxgen, Rising, Sciegen Pharms Inc, Sun Pharm, Sunshine, Unichem, and Vkt Pharma, and is included in twenty-six NDAs. There are two 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:	2
Tradenames:	3
Applicants:	26
NDAs:	26
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	27
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	85
Patent Applications:	3,648
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
Maria Sklodowska-Curie National Research Institute of Oncology	Phase 3
Polish Medical Research Agency	Phase 3
RenJi Hospital	Phase 4

See all RANOLAZINE clinical trials

Generic filers with tentative approvals for RANOLAZINE

Applicant	Application No.	Strength	Dosage Form
		1000MG	TABLET, EXTENDED RELEASE;ORAL
		500MG	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
Allied	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	213517-001	Apr 27, 2022	AB	RX	No	No
Allied	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	213517-002	Apr 27, 2022	AB	RX	No	No
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007		DISCN	Yes	No
Aurobindo Pharma	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	209081-001	Dec 23, 2022	AB	RX	No	No
Alkem Labs Ltd	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	209953-001	Nov 30, 2020	AB	RX	No	No
Rising	RANOLAZINE	ranolazine	TABLET, EXTENDED RELEASE;ORAL	212889-002	Jan 28, 2021	AB	RX	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	021526-001	Feb 12, 2007
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-002	Jan 27, 2006
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007

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/000805 Ranexa 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)

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

RANOLAZINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Ranolazine

Introduction to Ranolazine

Ranolazine, marketed under the brand name Ranexa, is a medication primarily used to treat chronic angina, a type of chest pain caused by reduced blood flow to the heart. Here, we delve into the market dynamics and financial trajectory of this crucial cardiovascular drug.

Market Growth Drivers

The global ranolazine market is driven by several key factors:

Increasing Prevalence of Chronic Angina

The rising incidence of chronic angina, driven by lifestyle changes, an aging population, and sedentary lifestyles, is a major driver for market growth. As the number of patients with chronic angina increases, the demand for effective treatment options like ranolazine also rises[1][3][5].

Advancements in Medical Technology

Technological advancements in the healthcare sector have led to the development of more accurate diagnostic tools and improved treatment options. These advancements have facilitated the diagnosis and management of chronic angina, thereby driving the demand for ranolazine[1][3].

Growing Healthcare Expenditure

Increasing healthcare expenditure across the globe, particularly in developing regions, has contributed to the growth of the ranolazine market. Higher healthcare spending allows for better access to medical facilities and medications, including ranolazine[1][3][5].

Market Segmentation and Regional Analysis

The ranolazine market is segmented based on various factors, including product types and geographical regions.

Product Types

Ranolazine is available in different formulations, such as 500 mg and 1000 mg tablets. The market is also seeing the development of novel formulations and combination drugs, which are expected to enhance patient compliance and outcomes[3][5].

Geographical Regions

• North America: This region dominates the global ranolazine market due to the high prevalence of cardiovascular diseases, well-established healthcare infrastructure, and favorable reimbursement policies[1][3][5].
• Europe: Europe represents a significant market for ranolazine, driven by the increasing elderly population and high prevalence of chronic angina. The region’s well-developed healthcare systems and presence of key market players contribute to market growth[1][3].
• Asia Pacific: This region is expected to witness substantial growth, driven by the growing geriatric population, changing lifestyles, and increasing healthcare expenditure in countries like China, India, and Japan[1][3][5].
• Latin America and Middle East & Africa: These regions offer potential growth opportunities due to improving healthcare infrastructure, rising awareness about cardiovascular diseases, and increasing disposable incomes[1][3].

Competitive Landscape

The ranolazine market is highly competitive, with several established players and emerging companies competing for market share.

Key Players

• Gilead Sciences: The original developer of ranolazine, marketed under the brand name Ranexa. Gilead is a significant player in the biopharmaceutical industry, with ranolazine contributing substantially to its cardiovascular segment[3].
• Lupin Pharmaceuticals: Known for its generic medications and specialty pharmaceuticals, Lupin has entered the ranolazine market through generic alternatives, enabling broader access[3].
• Teva Pharmaceutical Industries: One of the largest generic pharmaceutical companies globally, Teva's generic ranolazine has gained traction due to competitive pricing strategies[3].
• Ajanta Pharma: Focused on specialty and generic formulations, Ajanta has invested in expanding its cardiovascular segment, positioning it for future growth[3].

Financial Trajectory

The financial outlook for the ranolazine market is optimistic, with several factors contributing to its growth.

Market Size and Growth Rate

The global ranolazine market was valued at USD 1.5 billion in 2023 and is expected to reach USD 2.2 billion by 2031, growing at a CAGR of 4.5% from 2024 to 2031[5].

Revenue Generation

The growing demand for ranolazine presents significant revenue generation opportunities for pharmaceutical companies, distributors, and retailers. Strategic partnerships and collaborations can help companies expand their market presence and tap into new geographic regions[1][3].

Cost-Effectiveness

Studies have shown that add-on ranolazine therapy is cost-effective for chronic stable angina pectoris up to a 1-year time horizon, with a pooled incremental net benefit of US$1335. This cost-effectiveness is particularly significant from the payers' perspective[2].

Market Restraints and Challenges

Despite the positive growth prospects, the ranolazine market faces several challenges:

High Cost of Ranolazine

The retail cost of ranolazine, ranging between $400 and $500 per month, can be a significant financial burden for patients. This has led to the development of patient assistance programs to reduce out-of-pocket costs[4].

Competition from Alternative Treatments

The availability of alternative treatment options for chronic angina can pose a challenge to the growth of the ranolazine market. However, ranolazine's unique mechanism of action and effectiveness make it a preferred choice for many patients[1][3].

Future Outlook and Trends

The future of the ranolazine market is shaped by several trends and factors:

Integration of Digital Health Solutions

The integration of digital healthcare solutions, such as telemedicine and health monitoring apps, is expected to expand access and adherence to ranolazine prescriptions[3].

Personalized Medicine

The increasing focus on personalized medicine is expected to enhance the efficacy and maximize positive outcomes of ranolazine treatment[3].

Clinical Research Advancements

Ongoing studies exploring new indications for ranolazine beyond angina are likely to fuel interest and potential market expansion. Research into additional applications, such as heart failure and diabetic complications, could further bolster market growth[3].

Regulatory Support for New Formulations

Advances in drug delivery systems and regulatory support for new formulations are expected to enhance ranolazine's effectiveness and patient compliance[3].

Key Takeaways

• The global ranolazine market is driven by the increasing prevalence of chronic angina, advancements in medical technology, and growing healthcare expenditure.
• The market is segmented by product types and geographical regions, with North America dominating due to high prevalence of cardiovascular diseases.
• Key players include Gilead Sciences, Lupin Pharmaceuticals, Teva Pharmaceutical Industries, and Ajanta Pharma.
• The market faces challenges such as the high cost of ranolazine and competition from alternative treatments.
• Future trends include the integration of digital health solutions, personalized medicine, and clinical research advancements.

FAQs

What is the primary use of ranolazine?

Ranolazine is primarily used to treat chronic angina, a type of chest pain caused by reduced blood flow to the heart[1][3][4].

Which regions dominate the ranolazine market?

North America dominates the global ranolazine market due to the high prevalence of cardiovascular diseases and well-established healthcare infrastructure. The Asia Pacific region is also expected to witness significant growth[1][3][5].

Who are the key players in the ranolazine market?

Key players include Gilead Sciences, Lupin Pharmaceuticals, Teva Pharmaceutical Industries, and Ajanta Pharma[3].

Is ranolazine cost-effective for treating chronic angina?

Yes, studies have shown that add-on ranolazine therapy is cost-effective for chronic stable angina pectoris up to a 1-year time horizon[2].

What are the future trends shaping the ranolazine market?

Future trends include the integration of digital health solutions, personalized medicine, clinical research advancements, and regulatory support for new formulations[3].

Sources

1. Global Ranolazine market 2024-2032 | Size, Share, Growth - MarkWide Research
2. Cost-utility of Ranolazine for Chronic Stable Angina Pectoris - PubMed
3. Ranolazine Market Forecast: Revenue Trends and Growth - OpenPR
4. Ranexa Patient Assistance Programs - Simplefill
5. Ranolazine Market Size, Share and Forecast to 2031 - Market Research Intellect