Felodipine - Generic Drug Details

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

Felodipine is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Endo Operations, Glenmark Pharms Ltd, Heritage, Jubilant Generics, Mylan, Orbion Pharms, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Wockhardt, Yiling, Yung Shin Pharm, and Astrazeneca, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seventeen drug master file entries for felodipine. Fifteen suppliers are listed for this compound.

Summary for felodipine

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	20
Patent Applications:	7,220
Drug Prices:	Drug price trends for felodipine
Drug Sales Revenues:	Drug sales revenues for felodipine
What excipients (inactive ingredients) are in felodipine?	felodipine excipients list
DailyMed Link:	felodipine at DailyMed

See drug prices for felodipine

See drug sales revenues for felodipine

Recent Clinical Trials for felodipine

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

Sponsor	Phase
Guangzhou Kangqi Medical Technology Co., LTD	Phase 1
Overseas Pharmaceuticals, Ltd.	Phase 1
Menarini International Operations Luxembourg SA	Phase 4

See all felodipine clinical trials

Pharmacology for felodipine

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for felodipine

Anti-Arrhythmia Agents

Antihypertensive Agents

Calcium Channel Blockers

Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for felodipine

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

US Patents and Regulatory Information for felodipine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jubilant Generics	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	203983-003	Aug 19, 2016		DISCN	No	No
Jubilant Generics	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	203983-002	Aug 19, 2016		DISCN	No	No
Endo Operations	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	200815-001	Oct 28, 2011	AB	RX	No	No

Expired US Patents for felodipine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-002	Jul 25, 1991
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-004	Sep 22, 1994
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-002	Jul 25, 1991

Felodipine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Felodipine

Introduction to Felodipine

Felodipine, a dihydropyridine calcium channel blocker, is widely used in the management of hypertension and certain cardiovascular conditions. It works by inhibiting the influx of calcium ions through voltage-gated L-type calcium channels, leading to vasodilation and a subsequent decrease in blood pressure[2][5].

Market Growth and Projections

The felodipine market, including both ordinary and sustained-release tablets, is experiencing rapid and substantial growth. Here are some key points regarding its market dynamics and financial trajectory:

Market Size and Growth Rate

The felodipine tablets market is anticipated to exhibit significant expansion from 2023 to 2031, with a remarkable CAGR during the forecast period. The market size is projected to grow substantially, driven by increasing demand for effective hypertension management[1][3].

Segmentation

The market is segmented based on type (ordinary tablets and sustained-release tablets), application (treating high blood pressure, relieving angina, and others), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa). Sustained-release tablets, in particular, have seen a rapid surge due to their better patient compliance and reduced side effects[1][3].

Drivers of Market Growth

Increasing Prevalence of Hypertension

The global prevalence of hypertension and related cardiovascular diseases is a major driver of the felodipine market. As the population ages, the demand for effective antihypertensive medications like felodipine increases[4].

Personalized Medicine Trends

The trend towards personalized medicine has led to the development of extended-release formulations of felodipine, which enhance patient compliance and reduce side effects. This aligns with the shift towards patient-centric healthcare[4].

Cost Containment Efforts

Healthcare cost containment efforts have driven the market towards generic versions of felodipine, making it more accessible and affordable. This has contributed significantly to the market's growth[4].

Continuous R&D

The pharmaceutical industry's continuous research and development efforts to enhance drug delivery systems and efficacy also impact the market dynamics positively. Innovations in drug delivery methods have kept felodipine relevant in cardiovascular care[4].

Market Opportunities and Challenges

Opportunities

• Growing Demand for Generic Medications: The increasing demand for cost-effective generic versions of felodipine presents a significant opportunity for market growth.
• Emerging Markets: Expanding into emerging markets, particularly in Asia-Pacific and South America, offers new avenues for growth.
• Personalized Medicine: The development of personalized treatment plans using felodipine can further enhance its market position[1][3][4].

Challenges

• Regulatory Hurdles: Strict regulatory requirements and the need for continuous compliance can pose challenges.
• Competition from Other Antihypertensives: The presence of other antihypertensive medications, such as beta blockers and ACE inhibitors, can compete with felodipine for market share.
• Side Effects and Overdose Risks: While felodipine is generally well-tolerated, the risk of severe overdose and its associated complications can be a challenge[5].

Financial Trajectory

Revenue Projections

The felodipine market is expected to generate significant revenue throughout the forecast period from 2023 to 2031. The sustained-release tablet segment, in particular, is anticipated to contribute substantially to this revenue growth due to its higher patient compliance and reduced side effects[1][3].

Key Players and Market Share

Key players such as AstraZeneca, Sandoz, SHANXI KANGBO BIOLOGICAL PRODUCT, and others are significant contributors to the market. These companies are investing heavily in research and development to maintain their market share and expand their product offerings[1].

Pricing and Cost Analysis

The pricing of felodipine tablets varies based on the type and dosage. Extended-release tablets, while often more expensive than ordinary tablets, offer better value due to their prolonged action and reduced dosing frequency. The cost analysis includes considerations of raw material costs, manufacturing expenses, and market penetration at national and regional levels[2][4].

Regional Market Analysis

North America and Europe

These regions are expected to remain significant markets for felodipine due to the high prevalence of hypertension and well-established healthcare systems. However, the growth rate may be slower compared to emerging markets[1][3].

Asia-Pacific and South America

These regions are anticipated to experience rapid growth due to increasing healthcare spending, a growing aging population, and the expanding middle class. The demand for cost-effective antihypertensive medications is particularly high in these regions[1][3].

Conclusion

The felodipine market is poised for robust growth driven by increasing demand for effective hypertension management, personalized medicine trends, and cost containment efforts. While challenges such as regulatory hurdles and competition from other antihypertensives exist, the overall outlook remains optimistic.

Key Takeaways

• Market Growth: The felodipine market is expected to grow significantly from 2023 to 2031.
• Segmentation: The market is segmented into ordinary and sustained-release tablets, with sustained-release tablets driving growth.
• Drivers: Increasing prevalence of hypertension, personalized medicine trends, and cost containment efforts are key drivers.
• Opportunities: Growing demand for generics, emerging markets, and personalized medicine offer opportunities.
• Challenges: Regulatory hurdles, competition, and side effects are challenges to consider.
• Financial Trajectory: The market is projected to generate substantial revenue, with sustained-release tablets contributing significantly.

FAQs

1. What is the primary use of felodipine?

   • Felodipine is primarily used to treat mild to moderate essential hypertension and to relieve angina[2][5].

2. How does felodipine work?

   • Felodipine works by inhibiting the influx of calcium ions through voltage-gated L-type calcium channels, leading to vasodilation and a decrease in blood pressure[2].

3. What are the different types of felodipine tablets available?

   • Felodipine is available in ordinary tablets and sustained-release tablets, with various dosages such as 2.5 mg, 5 mg, and 10 mg[5].

4. What are the key drivers of the felodipine market?

   • The key drivers include the increasing prevalence of hypertension, personalized medicine trends, and healthcare cost containment efforts[4].

5. What are the potential side effects of felodipine?

   • Potential side effects include hypotension, reflex tachycardia, and in severe cases, life-threatening profound hypotension and bradycardia. It can also cause hyperglycemia due to decreased insulin release[5].

Sources

1. Market Research Intellect - Global Felodipine Tablets Market Size, Trends and Projections
2. DrugBank Online - Felodipine: Uses, Interactions, Mechanism of Action
3. Market Research Intellect - Global Felodipine Sustained-Release Tablet Market Size, Scope
4. IMARC Group - Felodipine (Plendil) Manufacturing Plant Project Report 2024
5. NCBI Bookshelf - Felodipine - StatPearls