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Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Baxter
UBS
Mallinckrodt
Chubb
Farmers Insurance
Johnson and Johnson
Fuji
Novartis

Generated: August 24, 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 Teva Pharms Usa, Mylan Pharms Inc, Apotex Inc, and Novartis, and is included in four 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-seven patent family members in thirty-eight countries.

There are sixteen drug master file entries for mycophenolic acid. Seven suppliers are listed for this compound.

Summary for Generic Name: mycophenolic acid

Tradenames:2
Patents:3
Applicants:4
NDAs:4
Drug Master File Entries: see list16
Suppliers / Packagers: see list7
Bulk Api Vendors: see list79
Clinical Trials: see list4,868
Patent Applications: see list9,692
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:mycophenolic acid at DailyMed

Pharmacology for Ingredient: mycophenolic acid

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex Inc
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL091558-001Aug 21, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Teva Pharms Usa
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL202720-002Oct 30, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Mylan Pharms Inc
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL091248-001Jan 8, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL091558-002Aug 19, 2014ABRXNoNo► 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
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004► Subscribe► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004► Subscribe► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004► Subscribe► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004► Subscribe► Subscribe
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International Patent Family for Ingredient: mycophenolic acid

Country Document Number Estimated Expiration
Poland189960► Subscribe
Netherlands300157► Subscribe
South Korea20000005360► Subscribe
Colombia4900024► Subscribe
Indonesia18663► Subscribe
Japan2006063086► Subscribe
Austria408415► Subscribe
Germany19781690► Subscribe
Australia2384397► Subscribe
Hungary9903373► 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
0157Netherlands► Subscribe300157, 20170410, EXPIRES: 20181009
C/GB04/030United Kingdom► SubscribeSPC/GB04/030: 20050609, EXPIRES: 20171023
0892640/01Switzerland► SubscribePRODUCT NAME: ACIDUM MYCOPHENOLICUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56115 24.10.2002
2004 00024Denmark► Subscribe
094Luxembourg► Subscribe91094, EXPIRES: 20181010
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Moodys
Merck
Argus Health
Boehringer Ingelheim
US Department of Justice
McKinsey
Novartis
Chubb
Baxter

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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ISSN: 2162-2639

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