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Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050791

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NDA 050791 describes MYFORTIC, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There is one patent protecting this drug and two Paragraph IV challenges. Additional details are available on the MYFORTIC profile page.

The generic ingredient in MYFORTIC is mycophenolic acid. There are seventeen 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 050791
Tradename:MYFORTIC
Applicant:Novartis
Ingredient:mycophenolic acid
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 050791
Medical Subject Heading (MeSH) Categories for 050791
Suppliers and Packaging for NDA: 050791
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791 NDA Novartis Pharmaceuticals Corporation 0078-0385 0078-0385-66 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0385-66)
MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791 NDA Novartis Pharmaceuticals Corporation 0078-0386 0078-0386-66 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0078-0386-66)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength180MG
Approval Date:Feb 27, 2004TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 27, 2018Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength360MG
Approval Date:Feb 27, 2004TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Feb 27, 2018Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 050791

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-002 Feb 27, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis MYFORTIC mycophenolic acid TABLET, DELAYED RELEASE;ORAL 050791-001 Feb 27, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
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Healthtrust
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Accenture
Medtronic
Mallinckrodt
Covington

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