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Last Updated: August 3, 2020

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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, Actavis Elizabeth, Chase Labs Nj, Heritage Pharma, Intergel Pharm, Leading Pharma Llc, Teva, Pfizer, Alvogen, Watson Labs, Watson Labs 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 thirty-one NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-nine drug master file entries for nifedipine. Thirty 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
Cao YuPhase 1
Ohio State UniversityPhase 4
Duke 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 XL TABLET, EXTENDED RELEASE;ORAL nifedipine 019684
ADALAT CC TABLET, EXTENDED RELEASE;ORAL nifedipine 020198
PROCARDIA CAPSULE;ORAL nifedipine 018482

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 210614-003 Mar 12, 2019 AB2 RX No No   Start Trial   Start Trial   Start Trial
Spil NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 210838-003 Apr 16, 2019 AB2 RX No No   Start Trial   Start Trial   Start Trial
Novast Labs NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 202987-002 Aug 25, 2016 AB1 RX No No   Start Trial   Start Trial   Start Trial
Alvogen ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-002 Apr 21, 1993 AB1 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novast Labs NIFEDIPINE nifedipine TABLET, EXTENDED RELEASE;ORAL 202987-003 Aug 25, 2016 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

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   Start Trial   Start Trial
Alvogen ADALAT CC nifedipine TABLET, EXTENDED RELEASE;ORAL 020198-002 Apr 21, 1993   Start Trial   Start Trial
Pfizer PROCARDIA nifedipine CAPSULE;ORAL 018482-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Pfizer PROCARDIA XL nifedipine TABLET, EXTENDED RELEASE;ORAL 019684-002 Sep 6, 1989   Start Trial   Start Trial
Pfizer PROCARDIA XL nifedipine TABLET, EXTENDED RELEASE;ORAL 019684-003 Sep 6, 1989   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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