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MYFORTIC Drug Profile

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Myfortic is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-seven patent family members in thirty-eight countries.

The generic ingredient in MYFORTIC is mycophenolic acid. There are sixteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the mycophenolic acid profile page.

Summary for Tradename: MYFORTIC

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Drug Prices: :see details

Pharmacology for Tradename: MYFORTIC

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004RXNo6,025,391► subscribeY ► subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-002Feb 27, 2004RXYes6,025,391► subscribeY ► subscribe
Novartis
MYFORTIC
mycophenolic acid
TABLET, DELAYED RELEASE;ORAL050791-001Feb 27, 2004RXNo6,172,107► subscribeY ► subscribe
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Paragraph IV activity for: MYFORTIC

Drugname Dosage Strength RLD Submissiondate
mycophenolic acidDelayed-release Tablets180 mgMyfortic6/4/2009
mycophenolic acidDelayed-release Tablets360 mgMyfortic2/2/2009

International Patent Family for Tradename: MYFORTIC

Country Document Number Estimated Expiration
Cyprus2243► subscribe
Malaysia119049► subscribe
Germany69727559► 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: MYFORTIC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/030United Kingdom► subscribeSPC/GB04/030: 20050609, EXPIRES: 20171023
2004 00024Denmark► subscribe
C017/2004Ireland► subscribeSPC017/2004, 20060201, EXPIRES: 20171023
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