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, Endo Operations, Glenmark Pharms Ltd, Heritage, Jubilant Generics, Mylan, Orbion Pharms, Sun Pharm Inds Ltd, Sun Pharm Industries, Torrent Pharms Ltd, Wockhardt, 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 |
Finished Product Suppliers / Packagers: | 15 |
Raw Ingredient (Bulk) Api Vendors: | 110 |
Clinical Trials: | 20 |
Patent Applications: | 7,220 |
Drug Prices: | Drug price trends for felodipine |
Drug Sales Revenues: | Drug sales revenues 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 |
---|---|
Overseas Pharmaceuticals, Ltd. | Phase 1 |
Guangzhou Kangqi Medical Technology Co., LTD | Phase 1 |
Menarini International Operations Luxembourg SA | Phase 4 |
Pharmacology for felodipine
Drug Class | Dihydropyridine Calcium Channel Blocker |
Mechanism of Action | Calcium Channel Antagonists |
Medical Subject Heading (MeSH) Categories for felodipine
Anatomical Therapeutic Chemical (ATC) Classes for felodipine
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Heritage | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 201964-001 | Nov 8, 2013 | AB | RX | No | 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 | ||||
Glenmark Pharms Ltd | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 090365-003 | Dec 17, 2010 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Endo Operations | FELODIPINE | felodipine | TABLET, EXTENDED RELEASE;ORAL | 200815-003 | Oct 28, 2011 | AB | RX | No | 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 felodipine
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 |
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