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Last Updated: July 29, 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-one 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

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SponsorPhase
University of CalgaryPhase 2/Phase 3
Prisma Health-UpstatePhase 4
Melanie Maykin, MDPhase 3

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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
Actavis Elizabeth NIFEDIPINE nifedipine CAPSULE;ORAL 072556-001 Sep 20, 1990 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Chase Labs Nj NIFEDIPINE nifedipine CAPSULE;ORAL 073421-001 Jun 19, 1991 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Bayer Pharms ADALAT nifedipine CAPSULE;ORAL 019478-002 Sep 17, 1986 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Labs Ltd NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 090602-001 Sep 13, 2010 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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
Pfizer PROCARDIA XL nifedipine TABLET, EXTENDED RELEASE;ORAL 019684-003 Sep 6, 1989 ⤷  Try it Free ⤷  Try it Free
Pfizer PROCARDIA XL nifedipine TABLET, EXTENDED RELEASE;ORAL 019684-003 Sep 6, 1989 ⤷  Try it Free ⤷  Try it Free
Pfizer PROCARDIA nifedipine CAPSULE;ORAL 018482-001 Approved Prior to Jan 1, 1982 ⤷  Try it Free ⤷  Try it Free
Alvogen ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-003 Apr 21, 1993 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKesson
Boehringer Ingelheim
Dow
AstraZeneca
Express Scripts
Medtronic

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