FELODIPINE - Generic Drug Details

What are the generic sources for felodipine and what is the scope of patent protection?

Felodipine is the generic ingredient in two branded drugs marketed by Aurobindo Pharma Ltd, Glenmark Pharms Ltd, Heritage, Jubilant Generics, Mylan, Orbion Pharms, Ph Health, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Wockhardt Bio Ag, 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. Fourteen 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:	14
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	20
Patent Applications:	7,114
Drug Prices:	Drug price trends 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
Overseas Pharmaceuticals, Ltd.	Phase 1
Guangzhou Kangqi Medical Technology Co., 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
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-001	Jul 25, 1991		DISCN	Yes	No
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-002	Jul 25, 1991		DISCN	Yes	No
Heritage	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	201964-003	Nov 8, 2013	AB	RX	No	No
Sun Pharm Industries	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	075896-002	Nov 2, 2004		DISCN	No	No
Yiling	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	210847-002	Oct 26, 2018	AB	RX	No	No
Yung Shin Pharm	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	204800-003	Apr 29, 2019	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	019834-004	Sep 22, 1994	4,264,611*PED
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-002	Jul 25, 1991	4,803,081*PED
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-004	Sep 22, 1994	4,803,081*PED
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-002	Jul 25, 1991	4,264,611*PED
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-001	Jul 25, 1991	4,803,081*PED
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-001	Jul 25, 1991	4,264,611*PED

Market Dynamics and Financial Trajectory for Felodipine

Last updated: February 19, 2026

Felodipine, a dihydropyridine calcium channel blocker, is prescribed primarily for hypertension and angina. Its market landscape is shaped by patent status, competition, regulatory policies, and evolving treatment protocols.

Market Position and Approval Status

Felodipine was developed by AstraZeneca, approved in Europe in 1988, and later gained approval in other markets, including the US. It is available under multiple brand names, with "Plendil" being a prominent US brand. Patent expiry occurred around 2008, leading to generic entry.

Patent and Generic Competition

Year	Event	Impact
2008	Patent expiry	Entry of generics, reducing pricing power
2010-2020	Increased generic penetration	Decline in branded sales, shift toward generics

The patent expiration caused a dramatic decline in branded revenues. Generics now hold over 85% of the market share globally for felodipine, according to IMS Health data.

Sales and Revenue Trends

Year	Estimated Global Sales (USD millions)	Notes
2010	400	Post-patent expiry, branded sales decline begins
2015	150	Market dominated by generics
2020	100	Continued downward trend

The sales reduction reflects increased generic competition, with some markets experiencing a 75% drop in branded pricing.

Market Drivers

• Efficacy and Safety Profile: Felodipine's selective vasodilation and minimal reflex tachycardia support its continued use.
• Generic Accessibility: Generics, offering lower prices, dominate prescriptions.
• Regulatory Environment: Generic approval processes facilitate market entry post-patent expiry.
• Treatment Guidelines: Hypertension management guidelines favor multiple first-line agents, with calcium channel blockers remaining prominent.

Market Challenges

• Pricing Pressure: Intense competition from generics leads to erosion of revenue streams.
• Market Saturation: High penetration limits potential for growth in established markets.
• Emerging Market Dynamics: Growth in non-innovator markets driven by cost considerations favors generics, further suppressing revenues.

Future Outlook

Assessing felodipine's future involves examining research activities and potential reformulations. No recent patent filings or significant R&D investments indicate limited innovation pipeline. The drug's pricing and market share will depend chiefly on regional prescribing patterns and insurance reimbursement policies.

Investment Implications

The landscape suggests limited revenue upside for branded versions of felodipine. Companies holding residual patents or proprietary formulations may sustain margins longer. Generic manufacturers benefit from established markets but face intense price competition.

Regulatory and Policy Influences

Global health agencies prioritize affordable hypertension medications, encouraging generic use. Regulatory hurdles, including bioequivalence and safety assessments, have streamlined approvals, further accelerating generics' market share growth.

Summary

Felodipine's market has transitioned from a branded product to a heavily genericized drug. Revenue declined sharply post-patent expiry, stabilizing at lower levels due to widespread generic use. Market dynamics are driven by price competition, regulatory policies, and treatment guidelines. No significant R&D activity suggests minimal pipeline innovation, and prospects for substantial market growth are limited.

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Key Takeaways

• Felodipine's patent ended around 2008, precipitating a sharp decline in branded sales.
• Generic drugs dominate the market, accounting for over 85% of worldwide prescriptions.
• Global sales have decreased from approximately USD 400 million in 2010 to USD 100 million in 2020.
• Market growth is constrained by patent expiry, intense competition, and treatment paradigm shifts.
• Future revenues will depend on regional policies, prescription habits, and the emergence of reformulations or combination therapies.

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FAQs

1. What is the primary use of felodipine?
It is prescribed to treat hypertension and angina due to its vasodilatory effects.

2. When did felodipine’s patent expire?
The patent expired around 2008, leading to increased generic entry.

3. How has the market share shifted post-patent expiry?
Generics now hold over 85% market share globally, reducing branded sales significantly.

4. Are there any ongoing development efforts for felodipine?
No significant new formulations or patent filings are publicly known, indicating a lack of active pipeline development.

5. What factors could influence felodipine's future revenue?
Regulatory changes, prescribing trends favoring or limiting calcium channel blockers, and the introduction of new therapies or combination drugs.

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References

[1] IMS Health. (2022). Global Market Data Reports.
[2] AstraZeneca. (2008). Felodipine patent expiration announcement.
[3] World Health Organization. (2020). Hypertension treatment guidelines.
[4] U.S. Food and Drug Administration. (2008). Summary of drug approvals and patent status.