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Serving leading biopharmaceutical companies globally:

McKinsey
Express Scripts
Fish and Richardson
Accenture
Chinese Patent Office
Fuji
Cerilliant
Julphar
AstraZeneca
Daiichi Sankyo

Generated: February 18, 2018

DrugPatentWatch Database Preview

Mycophenolic acid - Generic Drug Details

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What are the generic drug sources for mycophenolic acid and what is the scope of mycophenolic acid freedom to operate?

Mycophenolic acid
is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Apotex Inc, Mylan Pharms Inc, Teva Pharms Usa, and Novartis, and is included in five NDAs. There is one patent protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Mycophenolic acid has fifty-nine patent family members in thirty-eight countries.

There are seventeen drug master file entries for mycophenolic acid. Eight suppliers are listed for this compound.
Pharmacology for mycophenolic acid
Medical Subject Heading (MeSH) Categories for mycophenolic acid

US Patents and Regulatory Information for mycophenolic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 202555-001 Aug 23, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 202720-002 Oct 30, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Teva Pharms Usa MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 202720-001 Oct 30, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 091248-002 Jan 8, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 091248-001 Jan 8, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Accord Hlthcare MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 202555-002 Aug 23, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 091558-001 Aug 21, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apotex Inc MYCOPHENOLIC ACID mycophenolic acid TABLET, DELAYED RELEASE;ORAL 091558-002 Aug 19, 2014 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for mycophenolic acid

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

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Non-Orange Book US Patents for mycophenolic acid

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,025,391 Enteric-coated pharmaceutical compositions of mycophenolate ➤ Try a Free Trial
6,172,107 Entric-coated pharmaceutical compositions ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for mycophenolic acid

Supplementary Protection Certificates for mycophenolic acid

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
094 Luxembourg ➤ Try a Free Trial 91094, EXPIRES: 20181010
C017/2004 Ireland ➤ Try a Free Trial SPC017/2004, 20060201, EXPIRES: 20171023
0892640/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: ACIDUM MYCOPHENOLICUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56115 24.10.2002
0157 Netherlands ➤ Try a Free Trial 300157, 20170410, EXPIRES: 20181009
2004 00024 Denmark ➤ Try a Free Trial
C/GB04/030 United Kingdom ➤ Try a Free Trial SPC/GB04/030: 20050609, EXPIRES: 20171023
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Colorcon
Daiichi Sankyo
US Army
Chubb
Mallinckrodt
Healthtrust
Farmers Insurance
Merck

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 verifification 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.

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