Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Dow
Chubb
Cerilliant
Merck
Boehringer Ingelheim
Johnson and Johnson
Julphar
Harvard Business School
AstraZeneca

Generated: May 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050791

« Back to Dashboard

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
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:RXDosage:TABLET, DELAYED RELEASE;ORALStrength180MG
Approval Date:Feb 27, 2004TE:ABRLD:Yes
Patent:➤ Sign UpPatent 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:➤ Sign UpPatent 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 ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Federal Trade Commission
Colorcon
Queensland Health
Moodys
Mallinckrodt
McKinsey
AstraZeneca
Daiichi Sankyo

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.