Nifedipine - Generic Drug Details

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, Leading, Teva, Pfizer, Norwich, Watson Labs, Watson Labs Teva, Alembic, Alkem Labs Ltd, Aurobindo Pharma, Aurobindo Pharma Usa, Elite Pharm Solution, Martec Usa Llc, Mylan, Novast Labs, Osmotica Pharm Us, Par Pharm, Rising, Spil, Twi Pharms, Valeant Pharms North, Vitruvias, 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-six 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:	36
Raw Ingredient (Bulk) Api Vendors:	165
Clinical Trials:	164
Patent Applications:	6,952
Formulation / Manufacturing:	see details
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

See drug sales revenues for nifedipine

Recent Clinical Trials for nifedipine

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

Sponsor	Phase
Queen Mary University of London	N/A
Medical College of Wisconsin	Phase 3
Shaheed Zulfiqar Ali Bhutto Medical University	N/A

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

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
Martec Usa Llc	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	075414-003	Mar 23, 2004		DISCN	No	No
Osmotica Pharm Us	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	077127-002	Nov 21, 2005	AB2	RX	No	No
Valeant Pharms North	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	075289-002	Feb 6, 2001	AB2	RX	No	No
Twi Pharms	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	203126-003	Apr 3, 2014	AB2	RX	No	No
Alembic	NIFEDIPINE	nifedipine	TABLET, EXTENDED RELEASE;ORAL	216896-003	Nov 18, 2022	AB2	RX	No	No
Chase Labs Nj	NIFEDIPINE	nifedipine	CAPSULE;ORAL	073421-001	Jun 19, 1991		DISCN	No	No

Expired US Patents for nifedipine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-002	Sep 6, 1989
Norwich	ADALAT CC	nifedipine	TABLET, EXTENDED RELEASE;ORAL	020198-001	Apr 21, 1993
Pfizer	PROCARDIA	nifedipine	CAPSULE;ORAL	018482-002	Jul 24, 1986
Bayer Pharms	ADALAT	nifedipine	CAPSULE;ORAL	019478-002	Sep 17, 1986
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-003	Sep 6, 1989
Pfizer	PROCARDIA XL	nifedipine	TABLET, EXTENDED RELEASE;ORAL	019684-001	Sep 6, 1989