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Generated: May 29, 2017

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Mycophenolate mofetil hydrochloride - Generic Drug Details

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What are the generic sources for mycophenolate mofetil hydrochloride and what is the scope of mycophenolate mofetil hydrochloride freedom to operate?

Mycophenolate mofetil hydrochloride
is the generic ingredient in two branded drugs marketed by Akorn Inc, Roche Palo, Mylan Labs Ltd, and Par Sterile Products, and is included in four NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are thirty-six drug master file entries for mycophenolate mofetil hydrochloride. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: mycophenolate mofetil hydrochloride

Tradenames:2
Patents:1
Applicants:4
NDAs:4
Drug Master File Entries: see list36
Suppliers / Packagers: see list3
Bulk Api Vendors: see list8
Clinical Trials: see list1,328
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:mycophenolate mofetil hydrochloride at DailyMed

Pharmacology for Ingredient: mycophenolate mofetil hydrochloride

Tentative approvals for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe500MGINJECTABLE; INJECTION
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Labs Ltd
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION203859-001Mar 31, 2017APRXNoNo► Subscribe► Subscribe
Akorn Inc
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION204043-001Feb 28, 2017APRXNoNo► Subscribe► Subscribe
Par Sterile Products
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION203575-001Oct 28, 2016APRXNoNo► Subscribe► Subscribe
Roche Palo
CELLCEPT
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION050758-001Aug 12, 1998APRXYesYes► Subscribe► Subscribe
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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.

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