Siponimod fumaric acid - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for siponimod fumaric acid and what is the scope of freedom to operate?
Siponimod fumaric acid
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Siponimod fumaric acid has one hundred and thirty-eight patent family members in thirty-nine countries.
One supplier is listed for this compound.
Summary for siponimod fumaric acid
| International Patents: | 138 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | siponimod fumaric acid at DailyMed |
US Patents and Regulatory Information for siponimod fumaric acid
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-003 | Aug 24, 2021 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-003 | Aug 24, 2021 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-001 | Mar 26, 2019 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-003 | Aug 24, 2021 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for siponimod fumaric acid
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | PI0410439 | compostos e composições imunossupressoras | See Plans and Pricing |
| Canada | 2524047 | COMPOSES IMMUNOSUPPRESSEURS ET COMPOSITIONS (IMMUNOSUPPRESSANT COMPOUNDS AND COMPOSITIONS) | See Plans and Pricing |
| Australia | 2004240637 | Immunosuppressant compounds and compositions | See Plans and Pricing |
| Japan | 5941110 | See Plans and Pricing | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for siponimod fumaric acid
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2379069 | LUC00160 | Luxembourg | See Plans and Pricing | PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115 |
| 2379069 | C02379069/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67230 22.10.2020 |
| 2379069 | PA2020513 | Lithuania | See Plans and Pricing | PRODUCT NAME: SIPONIMODAS; REGISTRATION NO/DATE: EU/1/19/1414 20200113 |
| 2379069 | C202030029 | Spain | See Plans and Pricing | PRODUCT NAME: SIPONIMOD; NATIONAL AUTHORISATION NUMBER: EU/1/19/1414; DATE OF AUTHORISATION: 20200113; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1414; DATE OF FIRST AUTHORISATION IN EEA: 20200113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
