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Last Updated: November 4, 2024

MYCOPHENOLATE MOFETIL HYDROCHLORIDE - Generic Drug Details


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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
Recent Clinical Trials for MYCOPHENOLATE MOFETIL HYDROCHLORIDE

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

SponsorPhase
Fred Hutchinson Cancer CenterPhase 2
National Cord Blood NetworkPhase 2
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaPhase 1

See all MYCOPHENOLATE MOFETIL HYDROCHLORIDE clinical trials

Generic filers with tentative approvals for MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up500MGINJECTABLE; 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

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
Rising MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 204043-001 Feb 28, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Roche Palo CELLCEPT mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 050758-001 Aug 12, 1998 AP RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 212130-001 Jan 15, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
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
Zydus Pharms MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 204473-001 Aug 31, 2017 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bpi Labs MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 214283-001 Jun 1, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 211374-001 Mar 5, 2021 DISCN 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

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

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