Mycophenolate mofetil - Generic Drug Details
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What are the generic drug sources for mycophenolate mofetil and what is the scope of freedom to operate?
Mycophenolate mofetil
is the generic ingredient in four branded drugs marketed by Roche Palo, 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, Azurity, Apotex, Aurobindo Pharma, Bpi Labs, Endo Operations, Meitheal, Mylan Labs Ltd, Rising, Steriscience Speclts, and Zydus Pharms, and is included in fifty-one NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Mycophenolate mofetil has four patent family members in three countries.
There are twenty-nine drug master file entries for mycophenolate mofetil. Thirty suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for mycophenolate mofetil
International Patents: | 4 |
US Patents: | 3 |
Tradenames: | 4 |
Applicants: | 30 |
NDAs: | 51 |
Drug Master File Entries: | 29 |
Finished Product Suppliers / Packagers: | 30 |
Raw Ingredient (Bulk) Api Vendors: | 152 |
Clinical Trials: | 954 |
Patent Applications: | 7,690 |
Drug Prices: | Drug price trends for mycophenolate mofetil |
What excipients (inactive ingredients) are in mycophenolate mofetil? | mycophenolate mofetil excipients list |
DailyMed Link: | mycophenolate mofetil at DailyMed |
Recent Clinical Trials for mycophenolate mofetil
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Fred Hutchinson Cancer Center | Phase 2 |
National Cord Blood Network | Phase 2 |
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China | Phase 1 |
Generic filers with tentative approvals for MYCOPHENOLATE MOFETIL
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 500MG | INJECTABLE; 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
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex | MYCOPHENOLATE MOFETIL | mycophenolate mofetil | TABLET;ORAL | 090499-001 | Apr 22, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Strides Pharma | MYCOPHENOLATE MOFETIL | mycophenolate mofetil | CAPSULE;ORAL | 090111-001 | Dec 22, 2009 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Strides Pharma | MYCOPHENOLATE MOFETIL | mycophenolate mofetil | FOR SUSPENSION;ORAL | 212634-001 | Aug 29, 2023 | AB | RX | 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 |
Expired US Patents for mycophenolate mofetil
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Roche Palo | CELLCEPT | mycophenolate mofetil | CAPSULE;ORAL | 050722-001 | May 3, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Roche Palo | CELLCEPT | mycophenolate mofetil | TABLET;ORAL | 050723-001 | Jun 19, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Roche Palo | CELLCEPT | mycophenolate mofetil | FOR SUSPENSION;ORAL | 050759-001 | Oct 1, 1998 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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 |
International Patents for mycophenolate mofetil
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
European Patent Office | 3836898 | SUSPENSION PHARMACEUTIQUE POUR FORME GALÉNIQUE ORALE (PHARMACEUTICAL SUSPENSION FOR ORAL DOSAGE) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2020039263 | ⤷ Sign Up | |
United Kingdom | 2591396 | Pharmaceutical suspension for oral dosage | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for mycophenolate mofetil
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0281713 | SPC/GB96/026 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MYCOPHENOLATE MOFETIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 53337 19951103; CH 53338 19951103; UK EU/1/96/005/001 19960214; UK EU/96/005/002 19960214 |
0281713 | 96C0031 | Belgium | ⤷ Sign Up | PRODUCT NAME: MYCOPHENOLATE MOFETIL; NAT. REGISTRATION NO/DATE: EU/1/96/005/001 19960214; FIRST REGISTRATION: CH 53337 19951103 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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