Last Updated: September 25, 2026

Details for New Drug Application (NDA): 050791

✉ Email this page to a colleague

NDA 050791 describes MYFORTIC, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the MYFORTIC profile page.

The generic ingredient in MYFORTIC is mycophenolate sodium. There is one drug master file entry for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the mycophenolate sodium profile page.

Summary for 050791

Tradename:	MYFORTIC
Applicant:	Novartis
Ingredient:	mycophenolate sodium
Patents:	0

Pharmacology for NDA: 050791

Suppliers and Packaging for NDA: 050791

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MYFORTIC	mycophenolate sodium	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	mycophenolate sodium	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:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 180MG BASE
Approval Date:	Feb 27, 2004	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	EQ 360MG BASE
Approval Date:	Feb 27, 2004	TE:	AB	RLD:	Yes

Expired US Patents for NDA 050791

Subscribe to access the full database, or Start Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	⤷ Start Trial	⤷ Start Trial
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	⤷ Start Trial	⤷ Start Trial
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	⤷ Start Trial	⤷ Start Trial
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791-002	Feb 27, 2004	⤷ Start Trial	⤷ Start Trial
Novartis	MYFORTIC	mycophenolate sodium	TABLET, DELAYED RELEASE;ORAL	050791-001	Feb 27, 2004	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.