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Generated: April 26, 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 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

Drug Master File Entries: see list36
Suppliers / Packagers: see list3
Bulk Api Vendors: see list8
Clinical Trials: see list1,328
Patent Applications: see list24
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:mycophenolate mofetil hydrochloride at DailyMed

Pharmacology for Ingredient: mycophenolate mofetil hydrochloride


Applicant Application No. Form Dosage
► Subscribe► SubscribeINJECTABLE; INJECTION500MG
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Par Sterile Products
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION203575-001Oct 28, 2016APRXNoNo► Subscribe► Subscribe
Roche Palo
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION050758-001Aug 12, 1998APRXYesYes► Subscribe► Subscribe
Mylan Labs Ltd
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION203859-001Mar 31, 2017APRXNoNo► Subscribe► Subscribe
Akorn Inc
mycophenolate mofetil hydrochloride
INJECTABLE;INJECTION204043-001Feb 28, 2017APRXNoNo► Subscribe► Subscribe
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