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. Fifteen 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 GENERICS 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:	4,089
Formulation / Manufacturing:	see details
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

Anatomical Therapeutic Chemical (ATC) Classes for PLENDIL

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 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	019834-001	Jul 25, 1991
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-001	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	019834-002	Jul 25, 1991
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-004	Sep 22, 1994

International Patents for PLENDIL

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

Country	Patent Number	Title	Estimated Expiration
Australia	529116
Canada	1117530	3,5-DIESTERS ASSYMETRIQUES DE 2,6-DIMETHYL-4-2,3- PHENYL DISUBSTITUE-1,4-DIHYDROPYRIDINE-3,5-ACIDE DICARBOXYLIQUE, AYANT DES PROPRIETES D'HYPOTENSEURS; METHODE DE PREPARATION, ET PREPARATION PHARMACEUTIQUE A BASE DE CES PRODUITS (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 PREPARATIONAND PHARMACEUTICAL PREPARATION CONTAINING SAME)
Australia	7004387
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
Philippines	22494	NEW PHARMACEUTICAL PREPARATIONS WITH EXTENDED RELEASE
Japan	S62242613	SLOW RELEASE NOVEL MEDICINE

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