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Last Updated: June 16, 2021

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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. Twelve suppliers are listed for this compound. Additional details are available on the mycophenolic acid profile page.

DrugPatentWatch® 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

See drug prices for MYFORTIC

Recent Clinical Trials for MYFORTIC

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

SponsorPhase
Chiesi Farmaceutici S.p.A.Phase 4
Nantes University HospitalPhase 4
Zachariah Michael DeFilippPhase 1

See all MYFORTIC clinical trials

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   Get Started Free   Get Started Free   Get Started Free
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started 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 MYFORTIC

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004   Get Started Free   Get Started Free
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004   Get Started Free   Get Started Free
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004   Get Started Free   Get Started Free
>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   Get Started Free SPC/GB04/030: 20050609, EXPIRES: 20171023
0892640 CA 2004 00024 Denmark   Get Started Free
0892640 300157 Netherlands   Get Started Free 300157, 20170410, EXPIRES: 20181009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck
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Express Scripts
McKinsey

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