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Generated: May 20, 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 two suppliers. 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. Eight 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

Antibiotics, Antineoplastic
Antibiotics, Antitubercular
Enzyme Inhibitors

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	N	0078-0385-66
MYFORTIC	mycophenolic acid	TABLET, DELAYED RELEASE;ORAL	050791	NDA	Novartis Pharmaceuticals Corporation	0078-0386	N	0078-0386-66

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	180MG
Approval Date:	Feb 27, 2004	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Feb 27, 2018	Product Flag?	Y	Substance Flag?		Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	360MG
Approval Date:	Feb 27, 2004	TE:	AB	RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Feb 27, 2018	Product Flag?	Y	Substance Flag?		Delist Request?

Expired US Patents for NDA 050791

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

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