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Serving leading biopharmaceutical companies globally:

Argus Health
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US Army
Farmers Insurance
Healthtrust
Johnson and Johnson
Cerilliant
Boehringer Ingelheim
Julphar
Moodys

Generated: December 13, 2017

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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 are three patents 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 and six supplementary protection certificates in six countries.

There are sixteen 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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Teva Pharms UsaMYCOPHENOLIC ACIDmycophenolic acidTABLET, DELAYED RELEASE;ORAL202720-001Oct 30, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Mylan Pharms IncMYCOPHENOLIC ACIDmycophenolic acidTABLET, DELAYED RELEASE;ORAL091248-002Jan 8, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
NovartisMYFORTICmycophenolic acidTABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisMYFORTICmycophenolic acidTABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Mylan Pharms IncMYCOPHENOLIC ACIDmycophenolic acidTABLET, DELAYED RELEASE;ORAL091248-001Jan 8, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Accord HlthcareMYCOPHENOLIC ACIDmycophenolic acidTABLET, DELAYED RELEASE;ORAL202555-002Aug 23, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
NovartisMYFORTICmycophenolic acidTABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisMYFORTICmycophenolic acidTABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Apotex IncMYCOPHENOLIC ACIDmycophenolic acidTABLET, DELAYED RELEASE;ORAL091558-002Aug 19, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaMYCOPHENOLIC ACIDmycophenolic acidTABLET, DELAYED RELEASE;ORAL202720-002Oct 30, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: mycophenolic acid

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
NovartisMYFORTICmycophenolic acidTABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004► Subscribe► Subscribe
NovartisMYFORTICmycophenolic acidTABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004► Subscribe► Subscribe
NovartisMYFORTICmycophenolic acidTABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004► Subscribe► Subscribe
NovartisMYFORTICmycophenolic acidTABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004► Subscribe► Subscribe
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International Patent Family for Ingredient: mycophenolic acid

Country Document Number Estimated Expiration
Japan2006063086► Subscribe
Czech Republic9803267► Subscribe
Taiwan457098► Subscribe
Germany122004000038► Subscribe
Hungary224919► Subscribe
Brazil9708624► Subscribe
Poland329311► Subscribe
Hungary9903373► Subscribe
United Kingdom9622028► Subscribe
Spain2178510► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: MYCOPHENOLIC ACID

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C017/2004Ireland► SubscribeSPC017/2004, 20060201, EXPIRES: 20171023
0892640/01Switzerland► SubscribePRODUCT NAME: ACIDUM MYCOPHENOLICUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56115 24.10.2002
0157Netherlands► Subscribe300157, 20170410, EXPIRES: 20181009
C/GB04/030United Kingdom► SubscribeSPC/GB04/030: 20050609, EXPIRES: 20171023
2004 00024Denmark► Subscribe
094Luxembourg► Subscribe91094, EXPIRES: 20181010
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Serving leading biopharmaceutical companies globally:

Moodys
Healthtrust
Fuji
Mallinckrodt
McKesson
Medtronic
Merck
Fish and Richardson
AstraZeneca
Daiichi Sankyo

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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