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Mycophenolate mofetil - Generic Drug Details

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Mycophenolate mofetil is the generic ingredient in three branded drugs marketed by Alkem Labs Ltd, Vintage Pharms Llc, Roxane, Dr Reddys Labs Ltd, Accord Hlthcare, Apotex Corp, Mylan, Roche Palo, Zydus Pharms Usa Inc, Sandoz, Strides Pharma, Teva Pharms, Jubilant Cadista, Apotex, and Par Sterile Products, and is included in thirty NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-five drug master file entries for mycophenolate mofetil. Twenty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: mycophenolate mofetil

Tradenames:3
Patents:0
Applicants:15
NDAs:30
Drug Master File Entries: see list35
Suppliers / Packaging: see list22
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: mycophenolate mofetil

Tentative approvals for MYCOPHENOLATE MOFETIL

Applicant Application No. Form Dosage
<disabled><disabled>INJECTABLE; INJECTION500MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd
MYCOPHENOLATE MOFETIL
mycophenolate mofetil
CAPSULE;ORAL200197-001Jun 13, 2013RXNo► subscribe► subscribe
Roche Palo
CELLCEPT
mycophenolate mofetil
SUSPENSION;ORAL050759-001Oct 1, 1998RXYes► subscribe► subscribe
Roche Palo
CELLCEPT
mycophenolate mofetil
TABLET;ORAL050723-001Jun 19, 1997RXYes► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: mycophenolate mofetil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
CELLCEPT
mycophenolate mofetil
CAPSULE;ORAL050722-001May 3, 19954,753,935► subscribe
Roche Palo
CELLCEPT
mycophenolate mofetil
TABLET;ORAL050723-001Jun 19, 19974,753,935► subscribe
Roche Palo
CELLCEPT
mycophenolate mofetil
SUSPENSION;ORAL050759-001Oct 1, 19985,688,529► 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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