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 28, 2024

CELLCEPT Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Cellcept, and when can generic versions of Cellcept launch?

Cellcept is a drug marketed by Roche Palo and is included in four NDAs.

The generic ingredient in CELLCEPT 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 CELLCEPT
Drug Prices for CELLCEPT

See drug prices for CELLCEPT

Drug Sales Revenue Trends for CELLCEPT

See drug sales revenues for CELLCEPT

Recent Clinical Trials for CELLCEPT

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

SponsorPhase
University of California, DavisPhase 3
Medical College of WisconsinPhase 2
Paladin Labs Inc.Phase 4

See all CELLCEPT clinical trials

Pharmacology for CELLCEPT
Paragraph IV (Patent) Challenges for CELLCEPT
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 CELLCEPT

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 CAPSULE;ORAL 050722-001 May 3, 1995 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche Palo CELLCEPT mycophenolate mofetil TABLET;ORAL 050723-001 Jun 19, 1997 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Roche Palo CELLCEPT mycophenolate mofetil FOR SUSPENSION;ORAL 050759-001 Oct 1, 1998 AB RX Yes Yes ⤷  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 CELLCEPT

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for CELLCEPT

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for CELLCEPT

See the table below for patents covering CELLCEPT around the world.

Country Patent Number Title Estimated Expiration
Russian Federation 2150942 ORAL SUSPENSION CONTAINING HIGH DOSE OF MOFETIL MYCOPHENOLATE ⤷  Try a Trial
Japan H09509648 ⤷  Try a Trial
Japan S63188672 MORPHOLINO ETHYL ESTER OF MYCOPHENOLIC ACID AND ITS DERIVATIVE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CELLCEPT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0281713 C960019 Netherlands ⤷  Try a Trial PRODUCT NAME: MYCOFENOLAAT MOFETIL, DESGEWENST IN DE VORM VAN EEN FARMACEUTIS CH AANVAARDBAAR ZOUT, OF IN DE VORM VAN EEN ESTER MET EEN CARBO NZUUR MET DE FORMULE RCOOH WAARIN R EEN ALKYL- OF CYCLOALKYLGRO EP MET 1-6 KOOLSTOFATOMEN IS OF EEN UIT AL DAN NIET GESUBSTITUE; REGISTRATION NO/DATE: EU/1/96/005/001 - EU/1/96/005/002 19960214, IKS 53337-01 19951103
0281713 96C0031 Belgium ⤷  Try a Trial 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 ⤷  Try a Trial 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

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.