Mycophenolate mofetil - Generic Drug Details

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

International Patents:	4
US Patents:	3
Tradenames:	4
Applicants:	30
NDAs:	51
Drug Master File Entries:	29
Finished Product Suppliers / Packagers:	30
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	954
Patent Applications:	7,690
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
Fred Hutchinson Cancer Center	Phase 2
National Cord Blood Network	Phase 2
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China	Phase 1

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
Hikma	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065413-001	Jul 29, 2008	AB	RX	No	No
Endo Operations	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	203575-001	Oct 28, 2016	AP	RX	No	No
Teva Pharms Usa	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	FOR SUSPENSION;ORAL	211272-001	Jan 25, 2022	AB	RX	No	No
Strides Pharma	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	090456-001	Jun 10, 2010	AB	RX	No	No
Strides Pharma	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	CAPSULE;ORAL	090111-001	Dec 22, 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
Roche Palo	CELLCEPT	mycophenolate mofetil	CAPSULE;ORAL	050722-001	May 3, 1995
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998
Roche Palo	CELLCEPT	mycophenolate mofetil	FOR SUSPENSION;ORAL	050759-001	Oct 1, 1998

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

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)
World Intellectual Property Organization (WIPO)	2020039263
United Kingdom	2591396	Pharmaceutical suspension for oral dosage
United Kingdom	202103764

Supplementary Protection Certificates for mycophenolate mofetil

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
0281713	96C0031	Belgium		PRODUCT NAME: MYCOPHENOLATE MOFETIL; NAT. REGISTRATION NO/DATE: EU/1/96/005/001 19960214; FIRST REGISTRATION: CH 53337 19951103