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Last Updated: November 21, 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, Aurobindo Pharma, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms. and is included in forty-six NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Mycophenolate Mofetil

A generic version of MYCOPHENOLATE MOFETIL was approved as mycophenolate mofetil hydrochloride by ENDO OPERATIONS on October 28th, 2016.

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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
Fred Hutchinson Cancer CenterPhase 2
National Cord Blood NetworkPhase 2
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaPhase 1

See all MYCOPHENOLATE MOFETIL clinical trials

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
Endo Operations MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 203575-001 Oct 28, 2016 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Jubilant Cadista MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090661-001 Dec 15, 2014 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Steriscience Speclts MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 216390-001 Dec 23, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 217937-001 Feb 20, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065521-001 May 4, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Concord Biotech Ltd MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 212087-001 Jul 31, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 090253-001 May 4, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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