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, 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, Meitheal, Mylan Labs Ltd, Par Sterile Products, 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 PAR STERILE PRODUCTS on October 28th, 2016.
Summary for MYCOPHENOLATE MOFETIL
US Patents: | 0 |
Applicants: | 28 |
NDAs: | 45 |
Finished Product Suppliers / Packagers: | 29 |
Raw Ingredient (Bulk) Api Vendors: | 152 |
Clinical Trials: | 941 |
Patent Applications: | 3,296 |
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 |
---|---|
University Hospital, Rouen | Phase 4 |
Children's Hospital of Chongqing Medical University | Phase 2 |
Jewish General Hospital | Phase 2 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Labs Ltd | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 203859-001 | Mar 31, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Mylan | MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 065521-001 | May 4, 2009 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Zydus Pharms | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 204473-001 | Aug 31, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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/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 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |