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	019834-002	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

International Patents for PLENDIL

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

Country	Patent Number	Title	Estimated Expiration
Egypt	18265	NEW PHARMACEUTICAL PREPARATION WITH EXTENDED RELEASE
German Democratic Republic	263231	VERFAHREN ZUR HERSTELLUNG EINES FESTEN PRAEPARATES MIT VERZOEGERTER ABGABE EINES WIRKSTOFFES
European Patent Office	0007293	2,6-DIMETHYL-4-(2,3-DICHLOROPHENYL)-1,4-DIHYDROPYRIDINE-3,5-DICARBOXYLIC ACID-3-METHYL ESTER-5-ETHYL ESTER HAVING HYPOTENSIVE PROPERTIES, PROCESS FOR ITS PREPARATION AND PHARMACEUTICAL PREPARATIONS CONTAINING IT

Supplementary Protection Certificates for PLENDIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0007293	SPC/GB93/134	United Kingdom
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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: PLENDIL

Last updated: July 27, 2025

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Introduction

PLENDIL, generically known as felodipine, is a calcium channel blocker primarily prescribed for the management of hypertension and angina pectoris. Since its market introduction, PLENDIL has established a significant footprint within cardiovascular therapeutics, driven by its efficacy, safety profile, and evolving global health demands. This report analyzes the current market dynamics influencing PLENDIL's positioning, its financial trajectory, and key factors shaping its growth.

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Market Overview of PLENDIL

PLENDIL is a pivotal member of the dihydropyridine class of calcium channel blockers. Its widespread recognition stems from a favorable pharmacokinetic profile, minimal side effects, and proven clinical benefits in controlling blood pressure and reducing cardiovascular risk. The drug's patent protection phased out in various markets over the last decade, leading to the proliferation of generic formulations which substantially altered its market landscape.

The global antihypertensive market was valued at approximately $30 billion in 2022 and is projected to grow at a CAGR of 3-4% through 2030, reflecting increasing hypertension prevalence, aging populations, and heightened awareness driven by healthcare initiatives. PLENDIL’s segment, focused on calcium channel blockers, remains a significant share, owing to its efficacy and tolerability.

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Market Dynamics

1. Patent Expiry and Generic Competition

The expiration of PLENDIL’s key patents has precipitated a surge in generic versions, accounting for over 70% of its sales in mature markets. Generic entry typically leads to substantial price erosion—up to 80%—reducing revenue per unit for original manufacturers. Consequently, the original patent-holding companies faced declining margins; however, this also expanded overall market access and volume sales.

2. Pricing and Reimbursement Policies

Pricing strategies across regions significantly influence PLENDIL's financial performance. Developed markets, with stringent reimbursement controls, restrict price inflations, whereas emerging markets often present opportunities for premium pricing, contingent upon regulatory approval and local demand.

3. Regulatory and Approval Pathways

While PLENDIL has a well-established regulatory profile, ongoing clinical trials assessing its efficacy in combination therapies and new indications could extend its lifecycle. Regulatory agencies increasingly favor biosimilars and fixed-dose combinations, prompting companies to innovate on existing molecules.

4. Competitive Landscape

The competitive environment features several calcium channel blockers, including amlodipine, nifedipine, and newer agents like cilnidipine. These competitors challenge PLENDIL's market share, particularly when marketed as more convenient or cost-effective options.

5. Regional Market Expansion

Emerging markets, notably in Asia and Latin America, exhibit rising hypertension prevalence, fostering demand for affordable antihypertensive medications. Local generic manufacturers often dominate these markets, constraining growth for branded PLENDIL formulations.

6. Impact of Cardiovascular Disease Awareness

Public health campaigns emphasizing cardiovascular health have increased screening and treatment rates globally. This trend supports steady demand for antihypertensives, including PLENDIL, although patient preferences for combination therapies influence market penetration.

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Financial Trajectory

1. Revenue Trends

Post-patent expiration, original manufacturer revenues declined sharply, with sales reductions of up to 50% within five years in developed markets. However, total global sales maintained a steady trajectory due to increased volumes in emerging markets and expanded indications.

2. Profitability and Margins

While brand-name formulations face margin compression, generic sales, due to their lower manufacturing costs, partially offset revenue declines. The profitability of PLENDIL depends heavily on pricing strategies, patent litigation outcomes, and market share retention.

3. R&D and Lifecycle Extension Initiatives

Investments in extended-release formulations, fixed-dose combinations, and new therapeutic indications aim to prolong the drug’s lifecycle. For instance, combination therapies with statins or diuretics are gaining popularity, creating new revenue streams.

4. Strategic Collaborations and Licensing

Partnerships with regional distributors, licensing agreements for biosimilars, and co-development projects contribute to the financial outlook. These collaborations improve market access while sharing R&D burdens.

5. Market Forecasts

Analysts project the global sales of felodipine-based products to stabilize at approximately $1.2 billion by 2030, reflecting a combination of generic volume sales, new formulary launches, and regional expansion efforts. However, growth is tempered by intense competition and price pressures.

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Key Factors Impacting Future Trajectory

• Patent Litigation and Intellectual Property Rights: Protection periods influence exclusivity and pricing power.
• Innovation in Formulation: Extended-release and combination formulations can capture new market segments.
• Global Healthcare Policies: Rising healthcare expenditure and focus on non-communicable diseases favor antihypertensive medications.
• Market Penetration Strategies: Local manufacturing, pricing, and education campaigns determine success in emerging markets.
• Regulatory Developments: Approval of new formulations, particularly fixed-dose combinations, offers growth potential.

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Conclusion

PLENDIL’s market dynamics are marked by a transitioning landscape: patent expirations have ushered in generic competition, eroding margins but expanding access. Financially, the drug’s trajectory hinges on strategic innovation, regional expansion, and navigating regulatory environments. Continual adaptation—through lifecycle extension initiatives and partnerships—is vital for maintaining profitability and relevance in the evolving global antihypertensive market.

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Key Takeaways

• Patent expiration significantly shifted PLENDIL’s revenue models, with generics capturing major market share.
• Regional disparities in pricing and reimbursement influence geographical sales strategies.
• Formulation innovations and combination therapies are critical for lifecycle extension.
• Emerging markets present growth opportunities, counterbalanced by local generic competition.
• Ongoing clinical research and regulatory advancements sustain PLENDIL’s relevance and financial performance.

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FAQs

1. How has patent expiry affected PLENDIL’s market share?
Patent expiry led to a surge in generic versions, reducing brand-name sales but increasing overall market volume and accessibility. Original manufacturers have adapted through formulation innovations and strategic partnerships to maintain relevance.

2. What are the main competitors to PLENDIL in the antihypertensive market?
Amlodipine, nifedipine, and cilnidipine are primary competitors. These drugs often compete on price, efficacy, and convenience (e.g., once-daily dosing).

3. Can PLENDIL be used in combination therapies?
Yes. Combination therapies with statins or diuretics enhance treatment efficacy and patient compliance. Such formulations are gaining regulatory approval and market traction.

4. What emerging markets offer growth potential for PLENDIL?
Countries in Asia, Latin America, and Africa exhibit rising hypertension prevalence, providing considerable growth opportunities for affordable formulations.

5. What strategic initiatives can extend PLENDIL’s market lifespan?
Investing in novel formulations, expanding indications, securing regional licensing deals, and engaging in clinical trials for new therapeutic uses are key strategies.

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References

[1] GlobalData, "Antihypertensive Drugs Market Analysis," 2022.
[2] IQVIA Midas, "Pharmaceutical Sales Data," 2022.
[3] WHO, "Global Health Observatory Data," 2022.
[4] MarketWatch, "Calcium Channel Blockers Market Forecast," 2023.
[5] BCC Research, "Cardiovascular Therapeutics Market," 2022.