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Last Updated: March 19, 2024

MYCOPHENOLATE MOFETIL Drug Patent Profile


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Which patents cover Mycophenolate Mofetil, and what generic alternatives are available?

Mycophenolate Mofetil is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Corp, Aurobindo Pharma Ltd, Concord Biotech Ltd, Dr Reddys Labs Ltd, Hikma, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Teva Pharms, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Hetero Labs Ltd V, Lannett Co Inc, Teva Pharms Usa, Vistapharm, Apotex, Bpi Labs, Meitheal, Mylan Labs Ltd, Par Sterile Products, Rising, Steriscience, and Zydus Pharms. and is included in forty-four NDAs.

The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Drug patent expirations by year for MYCOPHENOLATE MOFETIL
Drug Prices for MYCOPHENOLATE MOFETIL

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Recent Clinical Trials for MYCOPHENOLATE MOFETIL

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SponsorPhase
University Hospital, RouenPhase 4
Children's Hospital of Chongqing Medical UniversityPhase 2
Kezar Life Sciences, Inc.Phase 2

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Pharmacology for MYCOPHENOLATE MOFETIL
Paragraph IV (Patent) Challenges for MYCOPHENOLATE MOFETIL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CELLCEPT For Oral Suspension mycophenolate mofetil 200 mg/mL 050759 1 2011-03-25

US Patents and Regulatory Information for MYCOPHENOLATE MOFETIL

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 mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 203575-001 Oct 28, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065451-001 Oct 15, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys Labs Ltd MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090464-001 Sep 13, 2010 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090456-001 Jun 10, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065413-001 Jul 29, 2008 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for MYCOPHENOLATE MOFETIL

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Passauer Pharma GmbH Myclausen mycophenolate mofetil EMEA/H/C/001218
Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.,
Authorised yes no no 2010-10-07
Roche Registration GmbH CellCept mycophenolate mofetil EMEA/H/C/000082
CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Authorised no no no 1996-02-14
Teva B.V. Myfenax mycophenolate mofetil EMEA/H/C/000884
Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Authorised yes no no 2008-02-21
Teva Pharma B.V. Mycophenolate mofetil Teva mycophenolate mofetil EMEA/H/C/000882
Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants.
Authorised yes no no 2008-02-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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