ISRADIPINE - Generic Drug Details

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

Isradipine is the generic ingredient in three branded drugs marketed by Smithkline Beecham, Elite Labs Inc, Watson Labs Teva, Glaxosmithkline Llc, and Norvium Bioscience, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for isradipine. Four suppliers are listed for this compound.

Summary for ISRADIPINE

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	5
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	119
Clinical Trials:	12
Patent Applications:	7,385
Drug Prices:	Drug price trends for ISRADIPINE
What excipients (inactive ingredients) are in ISRADIPINE?	ISRADIPINE excipients list
DailyMed Link:	ISRADIPINE at DailyMed

See drug prices for ISRADIPINE

Recent Clinical Trials for ISRADIPINE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Menarini International Operations Luxembourg SA	Phase 4
University of Texas at Austin	Early Phase 1
National Institute on Drug Abuse (NIDA)	Early Phase 1

See all ISRADIPINE clinical trials

Pharmacology for ISRADIPINE

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

Medical Subject Heading (MeSH) Categories for ISRADIPINE

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for ISRADIPINE

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 ISRADIPINE

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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
Norvium Bioscience	ISRADIPINE	isradipine	TABLET, EXTENDED RELEASE;ORAL	201067-002	Nov 27, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Norvium Bioscience	ISRADIPINE	isradipine	TABLET, EXTENDED RELEASE;ORAL	201067-001	Nov 27, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Teva	ISRADIPINE	isradipine	CAPSULE;ORAL	077317-002	Jan 5, 2006	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-002	Dec 20, 1990		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 ISRADIPINE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-002	Jun 1, 1994	⤷ Sign Up	⤷ Sign Up
Smithkline Beecham	DYNACIRC	isradipine	CAPSULE;ORAL	019546-001	Dec 20, 1990	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-001	Jun 1, 1994	⤷ Sign Up	⤷ Sign Up
Glaxosmithkline Llc	DYNACIRC CR	isradipine	TABLET, EXTENDED RELEASE;ORAL	020336-001	Jun 1, 1994	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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