MYCOPHENOLATE MOFETIL Drug Patent Profile
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Which patents cover Mycophenolate Mofetil, and what generic alternatives are available?
Mycophenolate Mofetil 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, and Zydus Pharms. and is included in forty-nine NDAs.
The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Seven 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
A generic version of MYCOPHENOLATE MOFETIL was approved as mycophenolate mofetil hydrochloride by PH HEALTH on October 28th, 2016.
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Questions you can ask:
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Summary for MYCOPHENOLATE MOFETIL
| US Patents: | 0 |
| Applicants: | 30 |
| NDAs: | 49 |
| Finished Product Suppliers / Packagers: | 27 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 1,009 |
| Drug Prices: | Drug price information for MYCOPHENOLATE MOFETIL |
| DailyMed Link: | MYCOPHENOLATE MOFETIL at DailyMed |
Recent Clinical Trials for MYCOPHENOLATE MOFETIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| City of Hope Medical Center | PHASE1 |
| National Cancer Institute (NCI) | PHASE1 |
| Mayo Clinic | PHASE2 |
Pharmacology for MYCOPHENOLATE MOFETIL
| Drug Class | Antimetabolite Immunosuppressant |
Paragraph IV (Patent) Challenges for MYCOPHENOLATE MOFETIL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| CELLCEPT | For Oral Suspension | mycophenolate mofetil | 200 mg/mL | 050759 | 1 | 2011-03-25 |
US Patents and Regulatory Information for MYCOPHENOLATE MOFETIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||
| Mylan Labs Ltd | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 203859-001 | Mar 31, 2017 | AP | 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 |
EU/EMA Drug Approvals for MYCOPHENOLATE MOFETIL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Passauer Pharma GmbH | Myclausen | mycophenolate mofetil | EMEA/H/C/001218Myclausen is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants., | Authorised | yes | no | no | 2010-10-07 | |
| Roche Registration GmbH | CellCept | mycophenolate mofetil | EMEA/H/C/000082CellCept is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. | Authorised | no | no | no | 1996-02-14 | |
| Teva B.V. | Myfenax | mycophenolate mofetil | EMEA/H/C/000884Myfenax is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. | Authorised | yes | no | no | 2008-02-21 | |
| Teva Pharma B.V. | Mycophenolate mofetil Teva | mycophenolate mofetil | EMEA/H/C/000882Mycophenolate mofetil Teva is indicated in combination with ciclosporin and corticosteroids for the prophylaxis of acute transplant rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. | Authorised | yes | no | no | 2008-02-21 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
