MYCOPHENOLIC SODIUM Drug Patent Profile
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Which patents cover Mycophenolic Sodium, and when can generic versions of Mycophenolic Sodium launch?
Mycophenolic Sodium is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Amta, Apotex Inc, Aurobindo Pharma Ltd, Biocon Pharma, Concord Biotech Ltd, Rk Pharma, Teva Pharms Usa, Twi Pharms, and Wanbang Biopharms. and is included in twelve 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.
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Questions you can ask:
- What is the 5 year forecast for MYCOPHENOLIC SODIUM?
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Summary for MYCOPHENOLIC SODIUM
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 17 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 21 |
| DailyMed Link: | MYCOPHENOLIC SODIUM at DailyMed |
Recent Clinical Trials for MYCOPHENOLIC SODIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AstraZeneca | Phase 3 |
| University Hospital, Tours | Phase 4 |
| Lee's Pharmaceutical Limited | Phase 4 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rk Pharma | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 091248-001 | Jan 8, 2014 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Wanbang Biopharms | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 216637-002 | May 29, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Apotex Inc | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 091558-001 | Aug 21, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | MYCOPHENOLIC SODIUM | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 208315-002 | Sep 23, 2021 | 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 |
