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 PHARMS LTD on December 17th, 2010.
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Summary for PLENDIL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 145 |
| Clinical Trials: | 4 |
| Patent Applications: | 4,082 |
| 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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-001 | Jul 25, 1991 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-002 | Jul 25, 1991 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | 019834-004 | Sep 22, 1994 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-001 | Jul 25, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-002 | Jul 25, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-002 | Jul 25, 1991 | ⤷ Sign Up | ⤷ Sign Up |
| >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 |
|---|---|---|---|
| German Democratic Republic | 144667 | VERFAHREN ZUR HERSTELLUNG VON 2,6-DIMETHYL-4-PHENYL-1,4-DIHYDROPYRIDIN-3,5-DICARBONSAEUREDIESTERN | ⤷ Sign Up |
| Ireland | 59419 | New pharmaceutical preparations with extended release | ⤷ Sign Up |
| Sweden | 8303617 | ⤷ Sign Up | |
| Czechoslovakia | 270560 | METHOD OF BIOLOGICALLY ACTIVE COMPOUNDS SOLUBILIZATION | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PLENDIL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0007293 | 95C0001 | Belgium | ⤷ Sign Up | PRODUCT NAME: FELODIPINE, METOPOLOL SUCCINATE; NAT. REGISTRATION NO/DATE: 122 IS 160 F 3 / 19921230; FIRST REGISTRATION: DK 8678 19921230 |
| 0265685 | SPC/GB98/047 | United Kingdom | ⤷ Sign Up | 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 |
| 0265685 | C980030 | Netherlands | ⤷ Sign Up | 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 | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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