Last Updated: June 22, 2026

MYCOPHENOLATE Drug Patent Profile


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When do Mycophenolate patents expire, and what generic alternatives are available?

Mycophenolate is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Corp, Aurobindo Pharma Ltd, Concord Biotech Ltd, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Strides Pharma Intl, Teva Pharms, Wuxi, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Lannett Co Inc, Rising, Teva Pharms Usa, Vistapharm Llc, Apotex, Aurobindo Pharma, Bpi Labs, Meitheal, Mylan Labs Ltd, Onesource Specialty, Ph Health, Zydus Pharms, Apotex Inc, Biocon Pharma, Fosun Wanbang, Rk Pharma, Twi Pharms, and Yichang Humanwell. and is included in sixty-one NDAs.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Mycophenolate

A generic version of MYCOPHENOLATE was approved as mycophenolate sodium by APOTEX INC on August 21st, 2012.

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Summary for MYCOPHENOLATE
US Patents:0
Applicants:36
NDAs:61
Drug Prices: Drug price information for MYCOPHENOLATE
DailyMed Link:MYCOPHENOLATE at DailyMed

US Patents and Regulatory Information for MYCOPHENOLATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yichang Humanwell MYCOPHENOLATE SODIUM mycophenolate sodium TABLET, DELAYED RELEASE;ORAL 214376-001 Feb 10, 2021 AB RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Zydus Pharms Usa Inc MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065477-001 May 4, 2009 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Dr Reddys Labs Ltd MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 090464-001 Sep 13, 2010 DISCN 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
Biocon Pharma MYCOPHENOLATE SODIUM mycophenolate sodium TABLET, DELAYED RELEASE;ORAL 214630-002 Nov 29, 2021 AB RX No No ⤷  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

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