Mycophenolate mofetil hydrochloride - Generic Drug Details
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What are the generic sources for mycophenolate mofetil hydrochloride and what is the scope of patent protection?
Mycophenolate mofetil hydrochloride
is the generic ingredient in two branded drugs marketed by Roche Palo, Amneal, Bpi Labs, Meitheal, Mylan Labs Ltd, Par Sterile Products, Rising, Steriscience, and Zydus Pharms, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.There is one drug master file entry for mycophenolate mofetil hydrochloride. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for mycophenolate mofetil hydrochloride
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 9 |
NDAs: | 9 |
Drug Master File Entries: | 1 |
Finished Product Suppliers / Packagers: | 12 |
Raw Ingredient (Bulk) Api Vendors: | 25 |
Clinical Trials: | 941 |
Patent Applications: | 229 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in mycophenolate mofetil hydrochloride? | mycophenolate mofetil hydrochloride excipients list |
DailyMed Link: | mycophenolate mofetil hydrochloride at DailyMed |
Recent Clinical Trials for mycophenolate mofetil hydrochloride
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 |
Generic filers with tentative approvals for MYCOPHENOLATE MOFETIL HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 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 hydrochloride
Drug Class | Antimetabolite Immunosuppressant |
US Patents and Regulatory Information for mycophenolate mofetil hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
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 | |||
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 | |||
Steriscience | MYCOPHENOLATE MOFETIL HYDROCHLORIDE | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 216390-001 | Dec 23, 2022 | 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 |
Expired US Patents for mycophenolate mofetil hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Roche Palo | CELLCEPT | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 050758-001 | Aug 12, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
Roche Palo | CELLCEPT | mycophenolate mofetil hydrochloride | INJECTABLE;INJECTION | 050758-001 | Aug 12, 1998 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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