Mycophenolate mofetil hydrochloride - Generic Drug Details

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

Mycophenolate mofetil hydrochloride is the generic ingredient in two branded drugs marketed by Roche Palo, Amneal, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for mycophenolate mofetil hydrochloride. Eleven suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for mycophenolate mofetil hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	954
Patent Applications:	229
What excipients (inactive ingredients) are in mycophenolate mofetil hydrochloride?	mycophenolate mofetil hydrochloride excipients list
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

Generic filers with tentative approvals for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

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 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
Zydus Pharms	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	204473-001	Aug 31, 2017	AP	RX	No	No
Mylan Labs Ltd	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	203859-001	Mar 31, 2017	AP	RX	No	No
Steriscience Speclts	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	216390-001	Dec 23, 2022	AP	RX	No	No
Amneal	MYCOPHENOLATE MOFETIL HYDROCHLORIDE	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	211374-001	Mar 5, 2021		DISCN	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
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998	AP	RX	Yes	Yes

Expired US Patents for mycophenolate mofetil hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998
Roche Palo	CELLCEPT	mycophenolate mofetil hydrochloride	INJECTABLE;INJECTION	050758-001	Aug 12, 1998