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Last Updated: April 17, 2021

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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, Akorn Inc, Mylan Labs Ltd, Par Sterile Products, and Zydus Pharms, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are thirty-eight drug master file entries for mycophenolate mofetil hydrochloride. Six suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for mycophenolate mofetil hydrochloride

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

SponsorPhase
Anelixis Therapeutics, Inc.Phase 2
University of Southern CaliforniaPhase 4
Roche Pharma AGPhase 3

See all mycophenolate mofetil hydrochloride clinical trials

Generic filers with tentative approvals for MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial500MGINJECTABLE; 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
Akorn Inc MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 204043-001 Feb 28, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Par Sterile Products MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 203575-001 Oct 28, 2016 AP RX No No   Start Trial   Start Trial   Start Trial
Zydus Pharms MYCOPHENOLATE MOFETIL HYDROCHLORIDE mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 204473-001 Aug 31, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Roche Palo CELLCEPT mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 050758-001 Aug 12, 1998 AP RX Yes Yes   Start Trial   Start Trial   Start Trial
>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   Start Trial   Start Trial
Roche Palo CELLCEPT mycophenolate mofetil hydrochloride INJECTABLE;INJECTION 050758-001 Aug 12, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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