PLENDIL Drug Patent Profile
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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 17th, 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 |
Anatomical Therapeutic Chemical (ATC) Classes for PLENDIL
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-001 | Jul 25, 1991 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-002 | Jul 25, 1991 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-001 | Jul 25, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-004 | Sep 22, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-002 | Jul 25, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-002 | Jul 25, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-004 | Sep 22, 1994 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PLENDIL
See the table below for patents covering PLENDIL around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 529116 | ⤷ Try a Trial | |
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) | ⤷ Try a Trial |
Australia | 7004387 | ⤷ Try a Trial | |
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 | ⤷ Try a Trial |
Philippines | 22494 | NEW PHARMACEUTICAL PREPARATIONS WITH EXTENDED RELEASE | ⤷ Try a Trial |
Japan | S62242613 | SLOW RELEASE NOVEL MEDICINE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PLENDIL
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0265685 | SPC/GB98/047 | United Kingdom | ⤷ Try a Trial | 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 | ⤷ Try a Trial | PRODUCT NAME: FELODIPINE, METOPOLOL SUCCINATE; NAT. REGISTRATION NO/DATE: 122 IS 160 F 3 / 19921230; FIRST REGISTRATION: DK 8678 19921230 |
0265685 | C980030 | Netherlands | ⤷ Try a Trial | 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 | ⤷ Try a Trial | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |