MYCOPHENOLIC SODIUM Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Mycophenolic Sodium, and when can generic versions of Mycophenolic Sodium launch?
Mycophenolic Sodium is a drug marketed by Accord Hlthcare, Airis Pharma Pvt Ltd, Alkem Labs Ltd, Amta, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Rk Pharma, Teva Pharms Usa, and Twi Pharms. and is included in eleven NDAs.
The generic ingredient in MYCOPHENOLIC SODIUM is mycophenolic sodium. There are seventeen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the mycophenolic sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Mycophenolic Sodium
A generic version of MYCOPHENOLIC SODIUM was approved as mycophenolic sodium by APOTEX INC on August 21st, 2012.
Summary for MYCOPHENOLIC SODIUM
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 20 |
| Patent Applications: | 571 |
| DailyMed Link: | MYCOPHENOLIC SODIUM at DailyMed |
Recent Clinical Trials for MYCOPHENOLIC SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Hospital, Tours | Phase 4 |
| Lee's Pharmaceutical Limited | Phase 4 |
| Surface Pharmaceuticals, Inc. | Phase 2 |
Pharmacology for MYCOPHENOLIC SODIUM
| Drug Class | Antimetabolite Immunosuppressant |
Paragraph IV (Patent) Challenges for MYCOPHENOLIC SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| MYFORTIC | Delayed-release Tablets | mycophenolic sodium | 180 mg | 050791 | 1 | 2009-06-03 |
| MYFORTIC | Delayed-release Tablets | mycophenolic sodium | 360 mg | 050791 | 1 | 2009-02-02 |
US Patents and Regulatory Information for MYCOPHENOLIC SODIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Accord Hlthcare | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 202555-001 | Aug 23, 2017 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rk Pharma | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 091248-001 | Jan 8, 2014 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amta | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 214376-001 | Feb 10, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Airis Pharma Pvt Ltd | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 217031-002 | Nov 29, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Aurobindo Pharma Ltd | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 218603-002 | Feb 27, 2024 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 202720-002 | Oct 30, 2014 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Amta | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 214376-002 | Feb 10, 2021 | AB | 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 |
