You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 19, 2024

Mycophenolate mofetil - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Mycophenolate mofetil is the generic ingredient in three 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, Apotex, Bpi Labs, Meitheal, Mylan Labs Ltd, Par Sterile Products, Rising, Steriscience, and Zydus Pharms, and is included in forty-eight NDAs. Additional information is available in the individual branded drug profile pages.

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.

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

See all mycophenolate mofetil clinical trials

Generic filers with tentative approvals for MYCOPHENOLATE MOFETIL
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial500MGINJECTABLE; 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
Roche Palo CELLCEPT mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 050758-001 Aug 12, 1998 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090606-001 Jul 16, 2010 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 204473-001 Aug 31, 2017 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 065520-001 May 4, 2009 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jubilant Cadista MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 090762-001 Dec 15, 2014 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc MYCOPHENOLATE MOFETIL mycophenolate mofetil FOR SUSPENSION;ORAL 214525-001 Jul 29, 2021 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

Expired US Patents for mycophenolate mofetil

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

Make Better Decisions: Try a trial or see plans & pricing

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 verification 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.