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Harvard Business School
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Last Updated: September 25, 2022

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. Fifteen 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
Chiesi Farmaceutici S.p.A.Phase 4
Nantes University HospitalPhase 4
Regimmune CorporationPhase 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis MYFORTIC mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novartis MYFORTIC mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 See Plans and Pricing See Plans and Pricing
Novartis MYFORTIC mycophenolic sodium TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 See Plans and Pricing See Plans and Pricing
>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
Poland 189356 See Plans and Pricing
South Africa 9703116 See Plans and Pricing
European Patent Office 0892640 COMPOSITIONS PHARMACEUTIQUES A DELITAGE ENTERIQUE ET A BASE DE MYCOPHENOLATE (ENTERIC-COATED PHARMACEUTICAL COMPOSITIONS OF MYCOPHENOLATE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MYFORTIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0892640 SPC/GB04/030 United Kingdom See Plans and Pricing SPC/GB04/030: 20050609, EXPIRES: 20171023
0892640 300157 Netherlands See Plans and Pricing 300157, 20170410, EXPIRES: 20181009
0892640 C00892640/01 Switzerland See Plans and Pricing PRODUCT NAME: ACIDUM MYCOPHENOLICUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56115 24.10.2002
>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

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.