MYCOPHENOLATE MOFETIL HYDROCHLORIDE Drug Patent Profile

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

Mycophenolate Mofetil Hydrochloride is a drug marketed by Amneal, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience, and Zydus Pharms. and is included in eight NDAs.

The generic ingredient in MYCOPHENOLATE MOFETIL HYDROCHLORIDE 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mycophenolate Mofetil Hydrochloride

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

Summary for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

US Patents:	0
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	952
Patent Applications:	137
Formulation / Manufacturing:	see details
DailyMed Link:	MYCOPHENOLATE MOFETIL HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

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 HYDROCHLORIDE clinical trials

Pharmacology for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Drug Class

Antimetabolite Immunosuppressant

US Patents and Regulatory Information for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	211374-001	Mar 5, 2021		DISCN	No	No
Steriscience	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	216390-001	Dec 23, 2022	AP	RX	No	No
Meitheal	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	212130-001	Jan 15, 2021	AP	RX	No	No
Zydus Pharms	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	204473-001	Aug 31, 2017	AP	RX	No	No
Bpi Labs	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	214283-001	Jun 1, 2023	AP	RX	No	No
Endo Operations	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	203575-001	Oct 28, 2016	AP	RX	No	No