PLENDIL Drug Patent Profile

Which patents cover Plendil, and when can generic versions of Plendil launch?

Plendil is a drug marketed by Astrazeneca and is included in one NDA.

The generic ingredient in PLENDIL is felodipine. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the felodipine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Plendil

A generic version of PLENDIL was approved as felodipine by GLENMARK PHARMS LTD on December 17^th, 2010.

Summary for PLENDIL

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	120
Clinical Trials:	4
Patent Applications:	5,403
DailyMed Link:	PLENDIL at DailyMed

Recent Clinical Trials for PLENDIL

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

Sponsor	Phase
Lawson Health Research Institute	Phase 1
Ranbaxy Laboratories Limited	N/A
LanZhou University	Phase 4

See all PLENDIL clinical trials

US Patents and Regulatory Information for PLENDIL

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	019834-004	Sep 22, 1994		DISCN	Yes	No
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

Expired US Patents for PLENDIL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-004	Sep 22, 1994
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
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-001	Jul 25, 1991
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-001	Jul 25, 1991

International Patents for PLENDIL

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

Country	Patent Number	Title	Estimated Expiration
Sweden	8601624
Sweden	8303617
Cyprus	1826	Solid pharmaceutical preparation with extended release and process for its preparation
New Zealand	219633	EXTENDED RELEASE SOLID PREPARATION
Greece	3005286
Hungary	204699	PROCESS FOR PROUDUCING PHARMACEUTICAL COMPOSITION WITH ELONGATED RELEASE OF ACTIVE INGREDIENT AND COMPRISING AN ACTIVE INGREDIENT HARDLY SOLUBLE IN WATER

Supplementary Protection Certificates for PLENDIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0265685	SPC/GB98/047	United Kingdom		PRODUCT NAME: COMBINATIONS OF RAMIPRIL, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, AND FELODIPINE, OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF.; REGISTERED: SE 13596 19970919; SE 13597 19970919; UK 00017/0402 19980825; UK 00017/0403 19980825
0007293	95C0001	Belgium		PRODUCT NAME: FELODIPINE, METOPOLOL SUCCINATE; NAT. REGISTRATION NO/DATE: 122 IS 160 F 3 / 19921230; FIRST REGISTRATION: DK 8678 19921230
0265685	C980030	Netherlands		PRODUCT NAME: FELODIPINE, DESGEWENST IN DE VORM VAN FYSIOLOGISCH AANVAARDBAAR ZOUT, EN (2S, 3AS, 6AS)-1-[(S)-N-[(S)-1-CARBOXY-3-FENYLPROPYL]A LANYL]OCTAHYDROCYCLOPENTA[B]-PYRROOL-2-CARBONZUUR (RAMIPRILAAT) , DESGEWENST IN DE VORM VAN EEN .....ZIE VERDER IN HET DOSSIER; NAT. REGISTRATION NO/ DATE: RVG 22449, RVG 22450 19980618; FIRST REGISTRATION: SE 13596, 13597 19970919
0007293	SPC/GB93/134	United Kingdom

Market Dynamics and Financial Trajectory for PLENDIL (Felodipine)

Last updated: January 16, 2026

Executive Summary

PLENDIL (felodipine) is a calcium channel blocker used predominantly in managing hypertension and angina pectoris. As a prescription medication with established efficacy, PLENDIL has maintained a stable market position in cardiovascular therapeutics. However, its future market dynamics are increasingly influenced by factors including generics entry, regulatory policies, regional adoption rates, and emerging competitors in the antihypertensive space. This report analyzes current market conditions, forecasts revenue trends, and examines the competitive landscape for PLENDIL, with strategic insights into navigating its evolving financial trajectory.

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What Are the Current Market Dynamics for PLENDIL?

Pharmacological Profile & Therapeutic Positioning

PLENDIL contains felodipine, a dihydropyridine calcium channel blocker indicated mainly for hypertension and chronic stable angina. It was first approved in the U.S. in 1997 and has since established itself globally, particularly in Europe and Asia. Its advantages include once-daily dosing, a favorable side effect profile, and extensive clinical trial backing [1].

Current Market Size and Share

• The global antihypertensive drugs market was valued at approximately $31.4 billion in 2022 and is projected to reach $46.5 billion by 2030 (CAGR: ~5.2%) [2].
• Within this scope, calcium channel blockers account for roughly 25% of antihypertensive prescriptions, with felodipine as one of the leading agents.

Key Markets (2023)	Market Size ($ millions)	Market Share (%)	Growth Rate (YoY)
United States	$3,200	10.2	2.5%
Europe	$2,100	6.7	3.0%
Asia-Pacific	$1,200	3.8	4.2%
Rest of World	$600	1.9	4.7%

Note: These figures include branded and generic sales, with generics accounting for over 70% of the volume.

Regulatory & Patent Climate

• The original patent for PLENDIL expired in the U.S. in 2012, leading to the proliferation of generics.
• In regions where patents are still active (e.g., some Asian markets), proprietary sales remain protected, maintaining higher margins.
• Regulatory frameworks such as EMA and FDA policies impact labeling, repurposing, and substitution practices, influencing market competition.

Competitive Landscape & Market Entrants

Competitors	Market Share (%)	Distinctive Features	Status
Amlodipine	35%	Widely prescribed, low cost	Dominates calcium channel blocker sector
Nifedipine	20%	Immediate-release formulations	Strong competition, moderate market share
Other CCBs	15%	Including diltiazem, verapamil	Niche markets
Generics (felodipine)	70% (volume)	Price competitiveness, increased prescription access	Market erosion for branded PLENDIL

Influence of Biosimilars & Generics

Generic entry, particularly post-patent expiry, has significantly reduced premium prices for branded PLENDIL. In Europe, generics command approximately 60-70% of the volume share, compressing revenues unless differentiated through formulations, delivery systems, or regional exclusivities.

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What Are the Revenue and Financial Trajectories for PLENDIL?

Historical Revenue Overview

Year	Branded PLENDIL Revenue ($ millions)	Generic Market Share (%)	Notes
2018	$850	40%	Peak branded sales
2020	$720	55%	Increased generic entry
2022	$650	70%	Market stabilization, price erosion

Forecasted Revenue Trends (2023-2028)

Given the current market and patent landscape, revenue for branded PLENDIL is expected to decline modestly by 2-4% annually, primarily driven by:

• Continued generic penetration
• Regional patent protections
• Potential switches to newer antihypertensives

Year	Projected Revenue ($ millions)	Comments
2023	$630	Sustained volume in key markets
2024	$610	Increased generics, price drops
2025	$580	Market saturation in mature regions
2026	$560	Emergence of biosimilars or new competitors (if any)
2027	$540	Potential repositioning, formulation upgrades optional
2028	$520	Continued decline, market stabilization

Profitability Outlook

Profit margins for PLENDIL are expected to narrow from approximately 35% in 2018 to an estimated 20-25% by 2028, due to intense price competition. Companies may focus on efficiency or diversification to maintain profitability.

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How Is the Regional and Policy Environment Shaping Market Access?

Regional Market Dynamics

Region	Key Trends	Regulatory Challenges	Market Access Factors
North America	Dominance of generics, high R&D focus	High regulatory standards	Insurance coverage, formulary inclusion
Europe	Multiple formulary tiers, strict patent laws	Post-approval variation	Reimbursement policies heavily influence prescribing
Asia-Pacific	Rapid growth, emerging healthcare infrastructure	Price sensitivity, patent challenges	Local manufacturing, government tenders dominate
Latin America & Africa	Growing hypertension burden	Limited infrastructure, affordability	Local partnerships, generic penetration

Policy Impacts

• Patent laws: Enforce or expire, affecting branded drug longevity.
• Pricing regulations: Governments enforce price caps, impacting profit margins.
• Therapeutic guidelines: Encouragement of first-line calcium channel blockers supports sustained demand.

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Comparison with Competitors & Emerging Alternatives

Parameter	PLENDIL (Felodipine)	Amlodipine	Nifedipine	Newer Agents (e.g., Telmisartan)
Patent Status	Expired (post-2012)	Expired	Expired	Varies (still under patent)
Price ($/unit)	$0.50 (generic)	$0.40	$0.35	$2+ (brand newer agents)
Dosing	Once daily	Once daily	Multiple forms	Once daily
Side Effect Profile	Favorable	Similar	Similar	Varies (newer agents have different profiles)
Market Penetration	High in prescription volume	Highest in volume	Significant competition	Growing in newer markets

What Are the Strategic Opportunities and Challenges?

Opportunities

• Formulation innovations: Extended-release or fixed-dose combinations to improve adherence.
• Regional differentiation: Leveraging regional exclusivities or formulations.
• Partnerships & Licensing: Collaboration in emerging markets with local firms.
• Lifecycle management: Developing novel formulations or combination therapies.

Challenges

• Generic erosion: Sustained revenue decline due to patent expiry.
• Pricing pressures: Government policies restraining pricing.
• Market saturation: Mature markets reaching maximum utilization.
• Emergence of competitors: New drugs providing similar or superior efficacy.

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Key Takeaways

• Market maturity and patent expiry have significantly affected branded PLENDIL’s revenue, with generics dominating sales in most regions.
• Global antihypertensive market remains robust, projected to grow at 5.2% CAGR until 2030, but brand-specific opportunities will diminish as generics capture more market share.
• Regional policies heavily influence market access and profitability, with Europe and North America facing harsher pricing regulations than emerging markets.
• Innovation and lifecycle management are critical for prolonging PLENDIL’s market relevance, including formulation improvements and regional brand strategies.
• Competitive landscape favors low-cost generics; thus, differentiating through formulations or strategic partnerships remains essential.

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FAQs

1. What are the main factors contributing to the decline of branded PLENDIL sales?
Patent expiration, aggressive generic competition, price pressures, and market saturation are primary factors reducing revenues.

2. How do regional regulatory policies impact PLENDIL’s market?
Regions with strict patent protections and favorable reimbursement policies facilitate continued branded sales, whereas countries with aggressive patent challenges or price controls hinder profitability.

3. Are there emerging competitors threatening PLENDIL’s market position?
Yes, newer antihypertensive agents, improved formulations, and combination therapies are challenging traditional calcium channel blockers’ dominance.

4. What strategies can pharmaceutical companies adopt to extend PLENDIL’s lifecycle?
Investments in formulation innovations, geographic expansion, strategic alliances, and exploring fixed-dose combinations can help extend market relevance.

5. How will the overall antihypertensive market evolution affect PLENDIL?
The market’s growth supports sustained demand, but increased generic penetration and shifts towards newer drugs necessitate strategic adaptation to maintain profitability.

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References

[1] European Medicines Agency. PLENDIL Summary of Product Characteristics. 2022.
[2] MarketWatch. Global Antihypertensive Drugs Market Report. 2023.