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Last Updated: April 22, 2024

MYFORTIC Drug Patent 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 sodium. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mycophenolic sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Myfortic

A generic version of MYFORTIC was approved as mycophenolic sodium 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
Nantes University HospitalPhase 4
Chiesi Farmaceutici S.p.A.Phase 4
Zachariah Michael DeFilippPhase 1

See all MYFORTIC clinical trials

Pharmacology for MYFORTIC
Paragraph IV (Patent) Challenges for MYFORTIC
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
MYFORTIC Delayed-release Tablets mycophenolic sodium 180 mg 050791 1 2009-06-03
MYFORTIC Delayed-release Tablets mycophenolic sodium 360 mg 050791 1 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 sodium TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novartis MYFORTIC mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 sodium TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Novartis MYFORTIC mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Novartis MYFORTIC mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Novartis MYFORTIC mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Novartis MYFORTIC mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
Novartis MYFORTIC mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for MYFORTIC

See the table below for patents covering MYFORTIC around the world.

Country Patent Number Title Estimated Expiration
Ireland 970267 ⤷  Try a Trial
Spain 2178510 COMPOSICIONES FARMACEUTICAS DE MICOFENOLATO REVESTIDAS ENTERICAMENTE. ⤷  Try a Trial
Italy RM970207 ⤷  Try a Trial
Slovenia 892640 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 9738689 ⤷  Try a Trial
Brazil 9708624 ⤷  Try a Trial
Colombia 4900024 COMPOSICIONES FARMACEUTICAS CON REVESTIMIENTO ETERICO ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MYFORTIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0892640 91094 Luxembourg ⤷  Try a Trial 91094, EXPIRES: 20181010
0892640 SPC017/2004 Ireland ⤷  Try a Trial SPC017/2004, 20060201, EXPIRES: 20171023
0892640 C00892640/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ACIDUM MYCOPHENOLICUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56115 24.10.2002
0892640 300157 Netherlands ⤷  Try a Trial 300157, 20170410, EXPIRES: 20181009
0892640 SPC/GB04/030 United Kingdom ⤷  Try a Trial SPC/GB04/030: 20050609, EXPIRES: 20171023
0892640 CA 2004 00024 Denmark ⤷  Try a Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.