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
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	46
Patent Applications:	2,267
Drug Prices:	Drug price information for RANEXA
Drug Sales Revenues:	Drug sales revenues 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
Policlinico Universitario Agostino Gemelli	Phase 4
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Phase 4
Menarini International Operations Luxembourg SA	Phase 2

See all RANEXA clinical trials

Pharmacology for RANEXA

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

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	021526-001	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
Menarini Intl	RANEXA	ranolazine	TABLET, EXTENDED RELEASE;ORAL	021526-001	Feb 12, 2007

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/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 RANEXA

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

Country	Patent Number	Title	Estimated Expiration
Mexico	PA02008654	FORMULACIONES DE RANOLAZINA DE LIBERACION PROLONGADA. (SUSTAINED RELEASE RANOLAZINE FORMULATIONS.)
Spain	8601947
New Zealand	510386	Sustained release ranolazine formulations
Hungary	0103844
European Patent Office	1109558	FORMULATIONS DE RANOLAZINE A LIBERATION LENTE (SUSTAINED RELEASE RANOLAZINE FORMULATIONS)
China	1211086
Poland	347073

Supplementary Protection Certificates for RANEXA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1109558	1/2009	Austria		PRODUCT NAME: RANOLAZIN ODER EIN SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080709
1109558	PA2008017,C1109558	Lithuania		PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006, 0080709
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
1109558	09C0001	France		PRODUCT NAME: RANOLAZINE; REGISTRATION NO/DATE: EU/1/08/462/001-006 20080714
1109558	PA2008017	Lithuania		PRODUCT NAME: RANOLAZINUM; REGISTRATION NO/DATE: EU/1/08/462/001 - EU/1/08/462/006 20080709
1109558	341	Finland
1109558	2008/034	Ireland		PRODUCT NAME: RANOLAZINE OR A SALT THEREOF; REGISTRATION NO/DATE: EU/1/08/462/001 20080709

RANEXA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ranexa (Ranolazine)

Introduction to Ranexa

Ranexa, known generically as ranolazine, is a prescription medication primarily used to treat chronic angina, a condition characterized by chest pain or discomfort due to reduced blood flow to the heart. Unlike other anti-angina drugs, Ranexa operates by affecting the sodium channels in the heart muscle, reducing the tension in the heart walls and improving blood flow[4].

Market Size and Growth

The global Ranolazine market is experiencing significant growth, driven by several key factors. The market is projected to grow at a moderate to high pace, with a Compound Annual Growth Rate (CAGR) of around 23.20% during the forecasted period[3].

• Increasing Demand for Anti-Angina Medications: The growing demand for anti-angina medications globally is a primary driver of the Ranolazine market. This demand is fueled by increasing cases of angina, which is often linked to lifestyle factors such as a westernized diet, smoking, obesity, and diabetes[1].
• R&D and Product Development: Increased investments in research and development (R&D) and the innovation of cost-effective production methods are expected to boost the market. These efforts aim to expand the therapeutic applications of ranolazine and make it more accessible[1].

Geographical Analysis

The global Ranolazine market is segmented into several geographical regions:

• North America: This region, particularly the United States, is the largest contributor to the Ranolazine market. The growth here is attributed to factors such as an increasing westernized diet and higher rates of smoking, obesity, and diabetes[1].
• Europe: Countries like Germany, the UK, and France are significant markets in Europe, driven by similar factors as North America.
• Asia Pacific: This region, including countries like China, Japan, and India, is also experiencing growth due to increasing healthcare spending and the adoption of advanced treatments.
• Rest of the World: This includes Latin America and the Middle East & Africa, where the market is growing due to improving healthcare infrastructure and increasing awareness of chronic conditions[1].

Key Players and Competitive Landscape

The Ranolazine market is dominated by several key players:

• JSN Chemicals
• Jubilant Pharma
• Cemex Pharma
• Precise Chemipharma
• Nuray Chemicals
• Emmennar
• SVK Laboratories Private Limited
• Ind-Swift Laboratories Ltd
• Wuhai Fulin Bio-Technology
• Srini

These companies are involved in intense competition, with strategies including product benchmarking, SWOT analysis, and significant investments in R&D to maintain market share and ranking[1].

Financial Trajectory

The financial performance of companies involved in the Ranolazine market is influenced by several factors:

• Revenue Growth: The market is expected to see substantial revenue growth driven by increasing demand and expanding research into additional indications[3].
• R&D Expenses: Companies are investing heavily in R&D to develop new and cost-effective methods of producing ranolazine. For example, Gilead Sciences, although not a primary player in the Ranolazine market, illustrates the importance of R&D investments with its significant expenditure in this area, which was $5.7 billion in 2023[2].
• Product Pricing: The pricing of Ranexa is influenced by various factors including R&D costs, market exclusivity, limited competition, and the broader healthcare system. These factors contribute to the high cost of the medication[4].

Factors Influencing Pricing

Several factors contribute to the high pricing of Ranexa:

• Research and Development Costs: The extensive and costly process of developing a new medication is a significant factor. Pharmaceutical companies recoup these costs through higher drug prices[4].
• Market Exclusivity and Patents: Patents grant manufacturers exclusive rights to produce and sell the drug, allowing them to maintain high prices during the patent period[4].
• Limited Competition: Even after patents expire, limited competition can keep prices high. The brand-name version of the drug often commands a premium price compared to generic versions[4].
• Pharmaceutical Pricing Strategies: Companies set prices based on production costs, the value the drug provides, and market dynamics[4].
• Healthcare System and Reimbursement: The way drugs are reimbursed by insurance companies and government programs also influences pricing[4].

Post-Market Surveillance and Ongoing Costs

After a drug is approved and brought to market, manufacturers continue to incur costs related to post-market surveillance, marketing, and further research. These ongoing expenses contribute to the high price of the drug[4].

Key Takeaways

• The global Ranolazine market is growing significantly due to increasing demand for anti-angina medications and advancements in R&D.
• The market is dominated by key players who invest heavily in R&D and compete through various strategies.
• Pricing is influenced by R&D costs, market exclusivity, limited competition, and the broader healthcare system.
• The financial trajectory of companies in this market is characterized by substantial investments in R&D and revenue growth driven by expanding therapeutic applications.

FAQs

1. What is Ranexa used for? Ranexa (ranolazine) is used to treat chronic angina, a condition characterized by chest pain or discomfort due to reduced blood flow to the heart.

2. How does Ranexa work? Ranexa works by affecting the sodium channels in the heart muscle, reducing the tension in the heart walls and improving blood flow.

3. Why is Ranexa so expensive? Ranexa is expensive due to high R&D costs, market exclusivity, limited competition, brand-name premium, pharmaceutical pricing strategies, and ongoing costs related to post-market surveillance and further research.

4. Which regions are the largest markets for Ranolazine? North America, particularly the United States, is the largest contributor to the Ranolazine market, followed by Europe and the Asia Pacific region.

5. What are the key factors driving the growth of the Ranolazine market? The growth of the Ranolazine market is driven by increasing demand for anti-angina medications, expanding research into additional indications, and significant investments in R&D.

Cited Sources:

1. Verified Market Research - Ranolazine Market Size, Share, Trends, Opportunities, Scope...
2. Gilead Sciences - Gilead Sciences Announces Fourth Quarter and Full Year 2023 Financial Results
3. OpenPR - Ranolazine Market Forecast: Revenue Trends and Growth
4. Offshore Cheap Meds - Why Is Ranexa So Expensive?
5. Gilead Sciences - Gilead Sciences Announces Third Quarter 2023 Financial Results