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:	145
Clinical Trials:	4
Patent Applications:	4,098
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	019834-001	Jul 25, 1991		DISCN	Yes	No
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-002	Jul 25, 1991		DISCN	Yes	No
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-004	Sep 22, 1994		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	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

International Patents for PLENDIL

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

Country	Patent Number	Title	Estimated Expiration
Cyprus	1299	NEW 2,6-DIMETHYL-4,2,3-DISUBSTITUTED PHENYL-1,4-DIHYDROPYRIDINE-3,5-DICARBOXYLIC ACID-3,5-ASYMMETRIC DIESTERS HAVING HYPOTENSIVE PROPERTIES,AS WELL AS PROCESS FOR THEIR PREPARATION AND PHARMACEUTICAL PREPARATION CONTAINING SAME
Czechoslovakia	8702587
Norway	174795
Sweden	7807404
Sweden	8303617

Supplementary Protection Certificates for PLENDIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for Plendil (Felodipine)

Introduction

Plendil, known generically as felodipine, is a calcium channel blocker used primarily for the management of hypertension and certain cardiovascular conditions. Here, we will delve into the market dynamics and financial trajectory of Plendil, highlighting its significance, market trends, and financial performance.

Mechanism of Action and Therapeutic Benefits

Felodipine belongs to the dihydropyridine class of calcium channel blockers. It works by relaxing blood vessels, thereby reducing blood pressure and enhancing cardiac function. This mechanism makes it an effective treatment for hypertension, contributing to improved cardiovascular health and patient quality of life[4].

Market Drivers

Several key factors drive the market for Plendil:

Increasing Prevalence of Hypertension

The global prevalence of hypertension is on the rise, driven by factors such as aging populations, lifestyle changes, and increasing awareness of cardiovascular diseases. This trend significantly boosts the demand for antihypertensive medications like Plendil[4].

Personalized Medicine

The shift towards personalized medicine has led to the development of extended-release formulations of felodipine. These formulations enhance patient compliance and reduce side effects, aligning with the patient-centric approach in healthcare[4].

Cost Containment Efforts

Healthcare cost containment efforts have driven the market towards generic versions of felodipine, making it more accessible and affordable for patients. This has expanded the market reach of Plendil beyond its original brand scope[4].

Innovation in Drug Delivery

Continuous research and development in the pharmaceutical industry aim to enhance drug delivery systems and efficacy. Innovations in this area further solidify Plendil's position in the market for cardiovascular care[4].

Financial Performance of Plendil

Historical Sales

Plendil was first approved in China in 1995 and has since become a significant contributor to AstraZeneca's revenue. In 2015, Plendil achieved product sales of $189 million in China alone[1].

Licensing Agreements

In 2016, AstraZeneca entered into a licensing agreement with China Medical System Holdings Ltd (CMS) for the commercialization rights of Plendil in China. Under this agreement, CMS paid AstraZeneca $310 million for the license. AstraZeneca retained the global rights to Plendil outside China and continued to manufacture and supply the medicine to CMS[1].

Revenue Impact

The licensing agreement with CMS contributed to AstraZeneca's financial performance, with the revenue from this agreement reported as Externalisation Revenue. This transaction did not impact AstraZeneca’s financial guidance for 2016 but ensured continued long-term revenues from Plendil sales in China[1].

Regional Market Performance

China Market

The China market has been crucial for Plendil's sales. Despite fluctuations in overall revenue due to various market factors, Plendil has maintained its significance. For instance, in the financial reports for 2023, Total Revenue from China was expected to return to growth, increasing by a low single-digit percentage, which includes contributions from established medicines like Plendil[2][5].

Global Market

Outside of China, Plendil's global sales have been part of AstraZeneca's broader portfolio. While specific global sales figures for Plendil are not always detailed separately, the drug's performance is integrated into the overall financial performance of AstraZeneca's cardiovascular and metabolic (CVRM) segment, which has shown significant growth. For example, in 2023, the CVRM segment saw an 18% growth in revenue, reflecting the strong performance of AstraZeneca's cardiovascular medicines, including Plendil[5].

Future Outlook

Market Trends

The sustained relevance of Plendil in the market is expected to continue due to its effectiveness in managing hypertension, the trend towards personalized medicine, and the demand for cost-effective options. Ongoing innovations in drug delivery methods will also support its market position[4].

Financial Projections

AstraZeneca's overall financial strategy and pipeline progress indicate a strong future outlook. The company expects to see double-digit revenue growth, excluding COVID-19 medicines, and plans to initiate numerous Phase III trials for high-potential medicines. This strategic focus on innovative medicines, while maintaining revenue from established products like Plendil, sets AstraZeneca on a path for continued industry-leading revenue growth through 2025 and beyond[2][5].

Key Takeaways

• Market Drivers: Increasing prevalence of hypertension, personalized medicine trends, cost containment efforts, and innovations in drug delivery.
• Financial Performance: Significant revenue contributions from licensing agreements and continued sales in key markets like China.
• Regional Performance: Strong performance in China and integrated into AstraZeneca's global CVRM segment.
• Future Outlook: Sustained market relevance due to effectiveness and ongoing innovations, with AstraZeneca expecting continued revenue growth.

FAQs

What is Plendil used for?

Plendil, or felodipine, is used primarily for the management of hypertension and certain cardiovascular conditions by relaxing blood vessels and reducing blood pressure.

Who manufactures Plendil?

Plendil is manufactured by AstraZeneca, although in China, the commercialization rights have been licensed to China Medical System Holdings Ltd (CMS).

What was the significance of the 2016 licensing agreement for Plendil?

The 2016 licensing agreement allowed CMS to commercialize Plendil in China, with AstraZeneca receiving $310 million and retaining global rights outside China.

How does Plendil fit into AstraZeneca's financial strategy?

Plendil is part of AstraZeneca's established product portfolio, contributing to revenue through licensing agreements and sales, while the company focuses on commercializing innovative new medicines.

What are the key market trends affecting Plendil's market position?

Key trends include the increasing prevalence of hypertension, the shift towards personalized medicine, healthcare cost containment efforts, and ongoing innovations in drug delivery methods.

Sources

1. AstraZeneca Press Release: "AstraZeneca enters licensing agreement with China Medical System Holdings for hypertension medicine Plendil" - February 29, 2016.
2. AstraZeneca Full-year and Q4 2022 Results Announcement - February 9, 2023.
3. AstraZeneca Annual Report and Form 20-F Information 2007 - December 31, 2007.
4. IMARC Group Report: "Felodipine (Plendil) Manufacturing Plant Project Report 2024" - 2024.
5. AstraZeneca Full-year and Q4 2023 Results Announcement - February 8, 2024.