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Mycophenolic acid - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for mycophenolic acid?

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.

This ingredient 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:4
Applicants:4
NDAs:4
Drug Master File Entries: see list16
Suppliers / Packagers: see list7
Bulk Api Vendors: see list79
Clinical Trials: see list2,083
Patent Applications: see list9,659
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004RXYesNo6,025,391► SubscribeY ► Subscribe
Teva Pharms Usa
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL202720-002Oct 30, 2014RXNoNo► Subscribe► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004RXYesYes6,025,391► SubscribeY ► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004RXYesNo6,172,107► SubscribeY ► Subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004RXYesYes6,172,107► SubscribeY ► Subscribe
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International Patent Family for Ingredient: mycophenolic acid

Country Document Number Estimated Expiration
Greece1002893► Subscribe
Poland189960► Subscribe
Slovenia892640► Subscribe
Portugal892640► Subscribe
Australia725388► 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
0157Netherlands► Subscribe300157, 20170410, EXPIRES: 20181009
094Luxembourg► Subscribe91094, EXPIRES: 20181010
2004 00024Denmark► Subscribe
C/GB04/030United Kingdom► SubscribeSPC/GB04/030: 20050609, EXPIRES: 20171023
C017/2004Ireland► SubscribeSPC017/2004, 20060201, EXPIRES: 20171023
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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 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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