MYFORTIC Drug Patent Profile
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Which patents cover Myfortic, and when can generic versions of Myfortic launch?
Myfortic is a drug marketed by Novartis and is included in one NDA.
The generic ingredient in MYFORTIC 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 Myfortic
A generic version of MYFORTIC was approved as mycophenolic sodium by APOTEX INC on August 21st, 2012.
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Summary for MYFORTIC
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 146 |
| Clinical Trials: | 118 |
| Drug Prices: | Drug price information for MYFORTIC |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for MYFORTIC |
| What excipients (inactive ingredients) are in MYFORTIC? | MYFORTIC excipients list |
| DailyMed Link: | MYFORTIC at DailyMed |
Recent Clinical Trials for MYFORTIC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Chiesi Farmaceutici S.p.A. | Phase 4 |
| Nantes University Hospital | Phase 4 |
| Zachariah Michael DeFilipp | Phase 1 |
Pharmacology for MYFORTIC
| Drug Class | Antimetabolite Immunosuppressant |
Paragraph IV (Patent) Challenges for MYFORTIC
| 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 MYFORTIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | AB | RX | Yes | Yes | ⤷ 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 MYFORTIC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-002 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | MYFORTIC | mycophenolic sodium | TABLET, DELAYED RELEASE;ORAL | 050791-001 | Feb 27, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for MYFORTIC
See the table below for patents covering MYFORTIC around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Italy | 1297045 | COMPOSIZIONI FARMACEUTICHE CON RIVESTIMENTO ENTERICO | ⤷ Sign Up |
| Hong Kong | 1016490 | ⤷ Sign Up | |
| Turkey | 9802056 | ⤷ Sign Up | |
| Italy | RM970207 | ⤷ Sign Up | |
| Spain | 2216141 | ⤷ Sign Up | |
| Spain | 2178510 | COMPOSICIONES FARMACEUTICAS DE MICOFENOLATO REVESTIDAS ENTERICAMENTE. | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for MYFORTIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0892640 | SPC/GB04/030 | United Kingdom | ⤷ Sign Up | SPC/GB04/030: 20050609, EXPIRES: 20171023 |
| 0892640 | C00892640/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ACIDUM MYCOPHENOLICUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 56115 24.10.2002 |
| 0892640 | 300157 | Netherlands | ⤷ Sign Up | 300157, 20170410, EXPIRES: 20181009 |
| 0892640 | CA 2004 00024 | Denmark | ⤷ Sign Up | |
| 0892640 | 91094 | Luxembourg | ⤷ Sign Up | 91094, EXPIRES: 20181010 |
| 0892640 | SPC017/2004 | Ireland | ⤷ Sign Up | SPC017/2004, 20060201, EXPIRES: 20171023 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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