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Serving leading biopharmaceutical companies globally:

McKesson
Medtronic
US Department of Justice
QuintilesIMS
Citi
Cantor Fitzgerald
Novartis
Cipla
Colorcon
Healthtrust

Generated: October 18, 2017

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 Teva Pharms Usa, Mylan Pharms Inc, Accord Hlthcare, Apotex Inc, 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.

Summary for Generic Name: mycophenolic acid

US Patents:3
Tradenames:2
Applicants:5
NDAs:5
Drug Master File Entries: see list16
Suppliers / Packagers: see list8
Bulk Api Vendors: see list79
Clinical Trials: see list4,911
Patent Applications: see list9,343
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
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Apotex Inc
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL091558-002Aug 19, 2014ABRXNoNo► Subscribe► Subscribe► 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
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Accord Hlthcare
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL202555-002Aug 23, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL091558-001Aug 21, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL091248-002Jan 8, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL091248-001Jan 8, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
MYCOPHENOLIC ACID
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL202720-001Oct 30, 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;ORAL050791-001Feb 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
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004► Subscribe► Subscribe
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International Patent Family for Ingredient: mycophenolic acid

Country Document Number Estimated Expiration
China1215991► Subscribe
France2747920► Subscribe
New Zealand332117► Subscribe
South Africa9703116► Subscribe
Austria259228► Subscribe
Greece1002893► Subscribe
Austria408415► Subscribe
United Kingdom9821304► Subscribe
Canada2250906► Subscribe
Luxembourg91094► 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
0892640/01Switzerland► SubscribePRODUCT NAME: ACIDUM MYCOPHENOLICUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56115 24.10.2002
2004 00024Denmark► Subscribe
C/GB04/030United Kingdom► SubscribeSPC/GB04/030: 20050609, EXPIRES: 20171023
094Luxembourg► Subscribe91094, EXPIRES: 20181010
C017/2004Ireland► SubscribeSPC017/2004, 20060201, EXPIRES: 20171023
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Accenture
Novartis
Farmers Insurance
Colorcon
Argus Health
Citi
Cerilliant
QuintilesIMS
Medtronic
Covington

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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