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Last Updated: November 4, 2024

MYCOPHENOLATE MOFETIL Drug Patent Profile

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Which patents cover Mycophenolate Mofetil, and what generic alternatives are available?

Mycophenolate Mofetil is a drug marketed by 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, Aurobindo Pharma, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms. and is included in forty-six NDAs.

The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mycophenolate Mofetil

A generic version of MYCOPHENOLATE MOFETIL was approved as mycophenolate mofetil hydrochloride by ENDO OPERATIONS on October 28^th, 2016.

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Summary for MYCOPHENOLATE MOFETIL

US Patents:	0
Applicants:	28
NDAs:	46
Finished Product Suppliers / Packagers:	28
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	954
Patent Applications:	4,341
Drug Prices:	Drug price information for MYCOPHENOLATE MOFETIL
DailyMed Link:	MYCOPHENOLATE MOFETIL at DailyMed

Drug patent expirations by year for MYCOPHENOLATE MOFETIL

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

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	203575-001	Oct 28, 2016	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Jubilant Cadista	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	090661-001	Dec 15, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Steriscience Speclts	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	216390-001	Dec 23, 2022	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	217937-001	Feb 20, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	065521-001	May 4, 2009	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Concord Biotech Ltd	MYCOPHENOLATE MOFETIL	mycophenolate mofetil	TABLET;ORAL	212087-001	Jul 31, 2020	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

EU/EMA Drug Approvals for MYCOPHENOLATE MOFETIL

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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

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