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Last Updated: May 6, 2021

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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, Leading Pharma Llc, Teva, Pfizer, Alvogen, Watson Labs, Watson Labs Teva, Elite, 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 thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

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

Drug Prices for nifedipine

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Drug Sales Revenue Trends for nifedipine

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Recent Clinical Trials for nifedipine

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

SponsorPhase
Prisma Health-UpstatePhase 4
Melanie Maykin, MDPhase 3
Cao YuPhase 1

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
ADALAT CC TABLET, EXTENDED RELEASE;ORAL nifedipine 020198
PROCARDIA CAPSULE;ORAL nifedipine 018482
PROCARDIA XL TABLET, EXTENDED RELEASE;ORAL nifedipine 019684

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
Novast Labs NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 210614-002 Mar 12, 2019 AB2 RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Valeant Pharms North NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 075269-002 Dec 4, 2000 AB1 RX No No   Get Started for $10   Get Started for $10   Get Started for $10
Osmotica Pharm Us NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 077127-001 Nov 21, 2005 AB2 RX No No   Get Started for $10   Get Started for $10   Get Started for $10
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alvogen ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-003 Apr 21, 1993   Get Started for $10   Get Started for $10
Pfizer PROCARDIA nifedipine CAPSULE;ORAL 018482-001 Approved Prior to Jan 1, 1982   Get Started for $10   Get Started for $10
Pfizer PROCARDIA XL nifedipine TABLET, EXTENDED RELEASE;ORAL 019684-003 Sep 6, 1989   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
Dow
Merck
Harvard Business School
Boehringer Ingelheim
Moodys

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