FELODIPINE - Generic Drug Details

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What are the generic sources for felodipine and what is the scope of patent protection?

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:	7,209
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

See drug prices for FELODIPINE

Drug Sales Revenue Trends for FELODIPINE

See drug sales revenues for FELODIPINE

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

See all FELODIPINE clinical trials

Pharmacology for FELODIPINE

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists

Medical Subject Heading (MeSH) Categories for FELODIPINE

Anti-Arrhythmia Agents
Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for FELODIPINE

C08CA	Dihydropyridine derivatives
C08C	SELECTIVE CALCIUM CHANNEL BLOCKERS WITH MAINLY VASCULAR EFFECTS
C08	CALCIUM CHANNEL BLOCKERS
C	Cardiovascular system

US Patents and Regulatory Information for FELODIPINE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Yung Shin Pharm	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	204800-001	Apr 29, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	091200-003	Dec 13, 2013	AB	RX	No	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
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-001	Jul 25, 1991	⤷ Sign Up	⤷ Sign Up
Astrazeneca	PLENDIL	felodipine	TABLET, EXTENDED RELEASE;ORAL	019834-004	Sep 22, 1994	⤷ 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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