MYCOPHENOLATE MOFETIL Drug Patent Profile
✉ Email this page to a colleague
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, Hikma, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Teva Pharms, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Hetero Labs Ltd V, Lannett Co Inc, Teva Pharms Usa, Vistapharm, Apotex, Aurobindo Pharma, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience, and Zydus Pharms. and is included in forty-five NDAs.
The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Twelve 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 ENDO OPERATIONS on October 28th, 2016.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for MYCOPHENOLATE MOFETIL?
- What are the global sales for MYCOPHENOLATE MOFETIL?
- What is Average Wholesale Price for MYCOPHENOLATE MOFETIL?
Summary for MYCOPHENOLATE MOFETIL
| US Patents: | 0 |
| Applicants: | 28 |
| NDAs: | 45 |
| Finished Product Suppliers / Packagers: | 29 |
| Raw Ingredient (Bulk) Api Vendors: | 152 |
| Clinical Trials: | 947 |
| Patent Applications: | 4,341 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Mansoura University | Early Phase 1 |
| The First Affiliated Hospital of Xiamen University | Phase 2/Phase 3 |
| University Hospital, Rouen | Phase 4 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Meitheal | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 212130-001 | Jan 15, 2021 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 065521-001 | May 4, 2009 | AB | 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 | |||
| Concord Biotech Ltd | MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 212087-001 | Jul 31, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Sandoz | MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 065451-001 | Oct 15, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys Labs Ltd | MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 090464-001 | Sep 13, 2010 | 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 |
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/001218 Myclausen 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/000082 CellCept 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/000884 Myfenax 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/000882 Mycophenolate 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 |
