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Last Updated: November 2, 2024

Mycophenolate mofetil - Generic Drug Details


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

Mycophenolate mofetil is the generic ingredient in four branded drugs marketed by Roche Palo, 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, Azurity, Apotex, Aurobindo Pharma, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms, and is included in fifty-one NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Mycophenolate mofetil has four patent family members in three countries.

There are twenty-nine drug master file entries for mycophenolate mofetil. Thirty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for mycophenolate mofetil
Drug Prices for mycophenolate mofetil

See drug prices for mycophenolate mofetil

Recent Clinical Trials for mycophenolate mofetil

Identify potential brand extensions & 505(b)(2) entrants

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

See all mycophenolate mofetil clinical trials

Generic filers with tentative approvals for MYCOPHENOLATE MOFETIL
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up500MGINJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
Teva Pharms MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 065491-001 May 6, 2009 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Pharms Usa Inc MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 065433-001 May 4, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090499-001 Apr 22, 2009 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065413-001 Jul 29, 2008 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma MYCOPHENOLATE MOFETIL mycophenolate mofetil FOR SUSPENSION;ORAL 212634-001 Aug 29, 2023 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

Expired US Patents for mycophenolate mofetil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo CELLCEPT mycophenolate mofetil TABLET;ORAL 050723-001 Jun 19, 1997 ⤷  Sign Up ⤷  Sign Up
Roche Palo CELLCEPT mycophenolate mofetil CAPSULE;ORAL 050722-001 May 3, 1995 ⤷  Sign Up ⤷  Sign Up
Roche Palo CELLCEPT mycophenolate mofetil FOR SUSPENSION;ORAL 050759-001 Oct 1, 1998 ⤷  Sign Up ⤷  Sign Up
Roche Palo CELLCEPT mycophenolate mofetil FOR SUSPENSION;ORAL 050759-001 Oct 1, 1998 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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

International Patents for mycophenolate mofetil

Country Patent Number Title Estimated Expiration
United Kingdom 202103764 ⤷  Sign Up
United Kingdom 2591396 Pharmaceutical suspension for oral dosage ⤷  Sign Up
European Patent Office 3836898 SUSPENSION PHARMACEUTIQUE POUR FORME GALÉNIQUE ORALE (PHARMACEUTICAL SUSPENSION FOR ORAL DOSAGE) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2020039263 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for mycophenolate mofetil

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0281713 96C0031 Belgium ⤷  Sign Up PRODUCT NAME: MYCOPHENOLATE MOFETIL; NAT. REGISTRATION NO/DATE: EU/1/96/005/001 19960214; FIRST REGISTRATION: CH 53337 19951103
0281713 SPC/GB96/026 United Kingdom ⤷  Sign Up PRODUCT NAME: MYCOPHENOLATE MOFETIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 53337 19951103; CH 53338 19951103; UK EU/1/96/005/001 19960214; UK EU/96/005/002 19960214
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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