Nifedipine - Generic Drug Details

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What are the generic sources for nifedipine and what is the scope of freedom to operate?

Nifedipine is the generic ingredient in six branded drugs marketed by Bayer Pharms, Acella, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Teva, Velzen Pharma Pvt, Pfizer, Norwich, Watson Labs, Watson Labs Teva, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Endo Operations, Martec Usa Llc, Norvium Bioscience, Novast Labs, Osmotica Pharm Us, Rising, Spil, Swiss Pharm, Twi Pharms, Valeant Pharms North, and Zydus Pharms, and is included in thirty-six NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for nifedipine. Thirty-eight suppliers are listed for this compound.

Summary for nifedipine

US Patents:	0
Tradenames:	6
Applicants:	27
NDAs:	36
Drug Master File Entries:	39
Finished Product Suppliers / Packagers:	38
Raw Ingredient (Bulk) Api Vendors:	165
Clinical Trials:	165
Patent Applications:	7,023
Drug Prices:	Drug price trends for nifedipine
Drug Sales Revenues:	Drug sales revenues for nifedipine
What excipients (inactive ingredients) are in nifedipine?	nifedipine excipients list
DailyMed Link:	nifedipine at DailyMed

See drug prices for nifedipine

Drug Sales Revenue Trends for nifedipine

See drug sales revenues for nifedipine

Recent Clinical Trials for nifedipine

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

Sponsor	Phase
Marshall University	Phase 2
Queen Mary University of London	N/A
Medical College of Wisconsin	Phase 3

See all nifedipine clinical trials

Pharmacology for nifedipine

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

Medical Subject Heading (MeSH) Categories for nifedipine

Calcium Channel Blockers
Tocolytic Agents
Vasodilator Agents

Anatomical Therapeutic Chemical (ATC) Classes for nifedipine

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 nifedipine

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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
Teva	NIFEDIPINE	nifedipine	CAPSULE;ORAL	072651-001	Feb 19, 1992		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	210614-003	Mar 12, 2019	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novast Labs	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	202987-003	Aug 25, 2016	AB1	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Spil	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	210838-002	Apr 16, 2019	AB2	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Heritage Pharma	NIFEDIPINE	nifedipine	CAPSULE;ORAL	202644-002	Apr 25, 2013	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	201071-001	Dec 3, 2010		DISCN	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 nifedipine

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989	⤷ Sign Up	⤷ Sign Up
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-003	Apr 21, 1993	⤷ Sign Up	⤷ Sign Up
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-002	Apr 21, 1993	⤷ Sign Up	⤷ Sign Up
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-001	Nov 27, 1985	⤷ Sign Up	⤷ Sign Up
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989	⤷ Sign Up	⤷ Sign Up
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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