MYCOPHENOLATE MOFETIL - Generic Drug Details

What are the generic drug sources for mycophenolate mofetil and what is the scope of patent protection?

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, Hetero Labs Ltd V, Hikma, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Strides Pharma Intl, Teva Pharms, Wuxi, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Lannett Co Inc, Rising, Teva Pharms Usa, Vistapharm Llc, Azurity, Apotex, Aurobindo Pharma, Bpi Labs, Meitheal, Mylan Labs Ltd, Onesource Specialty, Ph Health, and Zydus Pharms, and is included in fifty-four NDAs. There are five 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. Twenty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for MYCOPHENOLATE MOFETIL

International Patents:	4
US Patents:	5
Tradenames:	4
Applicants:	32
NDAs:	54
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	29
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1,009
Drug Prices:	Drug price trends for MYCOPHENOLATE MOFETIL
What excipients (inactive ingredients) are in MYCOPHENOLATE MOFETIL?	MYCOPHENOLATE MOFETIL excipients list
DailyMed Link:	MYCOPHENOLATE MOFETIL at DailyMed

See drug prices for MYCOPHENOLATE MOFETIL

Recent Clinical Trials for MYCOPHENOLATE MOFETIL

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

Sponsor	Phase
National Cancer Institute (NCI)	PHASE1
City of Hope Medical Center	PHASE1
Mayo Clinic	PHASE2

See all MYCOPHENOLATE MOFETIL clinical trials

Generic filers with tentative approvals for MYCOPHENOLATE MOFETIL

Applicant	Application No.	Strength	Dosage Form
		500MG	INJECTABLE; 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

Drug Class

Antimetabolite Immunosuppressant

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	TABLET;ORAL	065457-001	May 4, 2009		DISCN	No	No
Wuxi	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	214079-001	Nov 7, 2024	AB	RX	No	No
Dr Reddys Labs Ltd	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	090464-001	Sep 13, 2010		DISCN	No	No
Zydus Pharms Usa Inc	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	065433-001	May 4, 2009		DISCN	No	No

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	4,753,935
Roche Palo	CELLCEPT	mycophenolate mofetil	CAPSULE;ORAL	050722-001	May 3, 1995	4,753,935
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998	5,688,529
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998	4,753,935

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/001218Myclausen 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/000082CellCept 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/000884Myfenax 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/000882Mycophenolate 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

International Patents for MYCOPHENOLATE MOFETIL

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

Supplementary Protection Certificates for MYCOPHENOLATE MOFETIL

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0281713	96C0031	Belgium		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		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