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Felodipine - Generic Drug Details
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What are the generic drug sources for felodipine and what is the scope of freedom to operate?
Felodipine
is the generic ingredient in two branded drugs 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, Yung Shin Pharm, and Astrazeneca, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.There are seventeen drug master file entries for felodipine. Fifteen suppliers are listed for this compound.
Summary for felodipine
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 14 |
| NDAs: | 14 |
| Drug Master File Entries: | 17 |
| Suppliers / Packagers: | 15 |
| Bulk Api Vendors: | 124 |
| Clinical Trials: | 15 |
| Patent Applications: | 7,375 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for felodipine |
| What excipients (inactive ingredients) are in felodipine? | felodipine excipients list |
| DailyMed Link: | felodipine at DailyMed |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Vintage Pharms Llc | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 200815-001 | Oct 28, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Vintage Pharms Llc | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 200815-003 | Oct 28, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Glenmark Generics | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 090365-001 | Dec 17, 2010 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Heritage Pharms Inc | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 201964-003 | Nov 8, 2013 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Torrent Pharms Ltd | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 202170-003 | Nov 28, 2011 | AB | RX | No | Yes | Start Trial | Start Trial | Start Trial | |||
| Sun Pharm Inds Ltd | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 091200-002 | Dec 13, 2013 | 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 |
Expired US Patents for felodipine
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-001 | Jul 25, 1991 | Start Trial | Start Trial |
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-004 | Sep 22, 1994 | Start Trial | Start Trial |
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-002 | Jul 25, 1991 | Start Trial | Start Trial |
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-002 | Jul 25, 1991 | Start Trial | Start Trial |
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-004 | Sep 22, 1994 | Start Trial | Start Trial |
| Astrazeneca | PLENDIL | felodipine | TABLET, EXTENDED RELEASE;ORAL | 019834-001 | Jul 25, 1991 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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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.
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