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Last Updated: August 11, 2020

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NIFEDIPINE Drug Profile

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Which patents cover Nifedipine, and what generic alternatives are available?

Nifedipine is a drug marketed by Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Intergel Pharm, Leading Pharma Llc, Teva, Martec Usa Llc, Mylan, Mylan Labs Ltd, Novast Labs, Osmotica Pharm Us, Par Pharm, Spil, Twi Pharms, Valeant Pharms North, and Zydus Pharms. and is included in twenty-five NDAs.

The generic ingredient in NIFEDIPINE is nifedipine. There are thirty-nine drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the nifedipine profile page.

US ANDA Litigation and Generic Entry Outlook for Nifedipine

A generic version of NIFEDIPINE was approved as nifedipine by ACTAVIS ELIZABETH on September 20th, 1990.

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Drug patent expirations by year for NIFEDIPINE
Drug Prices for NIFEDIPINE

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Drug Sales Revenue Trends for NIFEDIPINE

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Recent Clinical Trials for NIFEDIPINE

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SponsorPhase
Cao YuPhase 1
Duke UniversityPhase 4
Ohio State UniversityPhase 4

See all NIFEDIPINE clinical trials

Pharmacology for NIFEDIPINE
Medical Subject Heading (MeSH) Categories for NIFEDIPINE
Paragraph IV (Patent) Challenges for NIFEDIPINE
Tradename Dosage Ingredient NDA Submissiondate
PROCARDIA CAPSULE;ORAL nifedipine 018482
PROCARDIA XL TABLET, EXTENDED RELEASE;ORAL nifedipine 019684
ADALAT CC TABLET, EXTENDED RELEASE;ORAL nifedipine 020198

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
Valeant Pharms North NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 075289-002 Feb 6, 2001 AB2 RX No No   Start Trial   Start Trial   Start Trial
Par Pharm NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 077899-002 Dec 13, 2006 AB1 RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 210012-003 Dec 19, 2017 AB2 RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 210012-001 Dec 19, 2017 AB2 RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 210184-003 Jun 29, 2018 AB1 RX No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

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Boehringer Ingelheim
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Harvard Business School
McKesson

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