Nisoldipine - Generic Drug Details

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

Nisoldipine is the generic ingredient in two branded drugs marketed by Amta, Mylan, and Covis, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for nisoldipine. Four suppliers are listed for this compound.

Summary for nisoldipine

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	4
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	117
Clinical Trials:	6
Patent Applications:	7,004
Drug Prices:	Drug price trends for nisoldipine
What excipients (inactive ingredients) are in nisoldipine?	nisoldipine excipients list
DailyMed Link:	nisoldipine at DailyMed

See drug prices for nisoldipine

Recent Clinical Trials for nisoldipine

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

Sponsor	Phase
Menarini International Operations Luxembourg SA	Phase 4
Mylan Pharmaceuticals	Phase 1
Bayer	Phase 4

See all nisoldipine clinical trials

Pharmacology for nisoldipine

Drug Class	Dihydropyridine Calcium Channel Blocker
Mechanism of Action	Calcium Channel Antagonists
Physiological Effect	Decreased Blood Pressure

Medical Subject Heading (MeSH) Categories for nisoldipine

Antihypertensive Agents
Calcium Channel Blockers
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for nisoldipine

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

Paragraph IV (Patent) Challenges for NISOLDIPINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SULAR	Extended-release Tablets	nisoldipine	8.5 mg and 17 mg	020356	1	2009-03-02
SULAR	Extended-release Tablets	nisoldipine	25.5 mg and 34 mg	020356	1	2008-11-28
SULAR	Extended-release Tablets	nisoldipine	20 mg and 30 mg	020356	1	2007-11-07
SULAR	Extended-release Tablets	nisoldipine	40 mg	020356	1	2007-06-11

US Patents and Regulatory Information for nisoldipine

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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
Mylan	NISOLDIPINE	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	091001-004	Jan 26, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-001	Feb 2, 1995		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-007	Jan 2, 2008	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-006	Jan 2, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	NISOLDIPINE	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	091001-002	Jan 26, 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 nisoldipine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-004	Feb 2, 1995	⤷ Sign Up	⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-005	Jan 2, 2008	⤷ Sign Up	⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-003	Feb 2, 1995	⤷ Sign Up	⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-008	Jan 2, 2008	⤷ Sign Up	⤷ Sign Up
Covis	SULAR	nisoldipine	TABLET, EXTENDED RELEASE;ORAL	020356-001	Feb 2, 1995	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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