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FELODIPINE Drug Profile
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Which patents cover Felodipine, and what generic alternatives are available?
Felodipine is a drug marketed by Aurobindo Pharma Ltd, Glenmark Generics, Heritage Pharms Inc, Jubilant Generics, Mylan, Orchid Hlthcare, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Vintage Pharms Llc, Wockhardt Ltd, Yiling, and Yung Shin Pharm. and is included in thirteen NDAs.
The generic ingredient in FELODIPINE 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 Felodipine
A generic version of FELODIPINE was approved as felodipine by SUN PHARM INDUSTRIES on November 2nd, 2004.
Summary for FELODIPINE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 13 |
| Suppliers / Packagers: | 15 |
| Bulk Api Vendors: | 124 |
| Clinical Trials: | 15 |
| Patent Applications: | 4,212 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for FELODIPINE |
| DailyMed Link: | FELODIPINE at DailyMed |
See drug prices for FELODIPINE
Recent Clinical Trials for FELODIPINE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rigshospitalet, Denmark | Phase 4 |
| Lawson Health Research Institute | Phase 1 |
| Lee's Pharmaceutical Limited | Phase 4 |
Pharmacology for FELODIPINE
| Drug Class | Dihydropyridine Calcium Channel Blocker |
| Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for FELODIPINE
Paragraph IV (Patent) Challenges for FELODIPINE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| PLENDIL | TABLET, EXTENDED RELEASE;ORAL | felodipine | 019834 |
US Patents and Regulatory Information for FELODIPINE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Wockhardt Ltd | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 091484-002 | Aug 15, 2012 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Vintage Pharms Llc | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 200815-001 | Oct 28, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Wockhardt Ltd | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 091484-003 | Aug 15, 2012 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Vintage Pharms Llc | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 200815-002 | Oct 28, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
