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Last Updated: July 10, 2020

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MYFORTIC Drug Profile


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Which patents cover Myfortic, and when can generic versions of Myfortic launch?

Myfortic is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in MYFORTIC is mycophenolic acid. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the mycophenolic acid profile page.

US ANDA Litigation and Generic Entry Outlook for Myfortic

A generic version of MYFORTIC was approved as mycophenolic acid by APOTEX INC on August 21st, 2012.

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Drug patent expirations by year for MYFORTIC
Drug Prices for MYFORTIC

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Recent Clinical Trials for MYFORTIC

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

SponsorPhase
Simon TremblayPhase 4
Veloxis PharmaceuticalsPhase 4
City of Hope Medical CenterPhase 1

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Pharmacology for MYFORTIC
Paragraph IV (Patent) Challenges for MYFORTIC
Tradename Dosage Ingredient NDA Submissiondate
MYFORTIC TABLET, DELAYED RELEASE;ORAL mycophenolic acid 050791 2009-06-03
MYFORTIC TABLET, DELAYED RELEASE;ORAL mycophenolic acid 050791 2009-02-02

US Patents and Regulatory Information for MYFORTIC

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 AB RX Yes Yes   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 MYFORTIC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004   Start Trial   Start Trial
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004   Start Trial   Start Trial
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004   Start Trial   Start Trial
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for MYFORTIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0892640 SPC/GB04/030 United Kingdom   Start Trial SPC/GB04/030: 20050609, EXPIRES: 20171023
0892640 SPC017/2004 Ireland   Start Trial SPC017/2004, 20060201, EXPIRES: 20171023
0892640 300157 Netherlands   Start Trial 300157, 20170410, EXPIRES: 20181009
0892640 CA 2004 00024 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Baxter
Johnson and Johnson
Express Scripts
McKinsey

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