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Siponimod fumaric acid - Generic Drug Details
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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-six patent family members in thirty-eight countries.
One supplier is listed for this compound.
Summary for siponimod fumaric acid
| International Patents: | 136 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| 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 | 209884-002 | Mar 26, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-001 | Mar 26, 2019 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-002 | Mar 26, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-002 | Mar 26, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Novartis | MAYZENT | siponimod fumaric acid | TABLET;ORAL | 209884-001 | Mar 26, 2019 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >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 | Estimated Expiration |
|---|---|---|
| Chile | 2004001119 | Start Trial |
| Tunisia | 2011000281 | Start Trial |
| China | 1791592 | Start Trial |
| Spain | 2467160 | Start Trial |
| China | 1791395 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for siponimod fumaric acid
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2379069 | LUC00160 | Luxembourg | Start Trial | PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115 |
| 2379069 | 2020C/526 | Belgium | Start Trial | PRODUCT NAME: SIPONIMOD; AUTHORISATION NUMBER AND DATE: EU/1/19/1414 20200115 |
| 2379069 | 301046 | Netherlands | Start Trial | PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 20200115 |
| 2379069 | 21/2020 | Austria | Start Trial | PRODUCT NAME: SIPONIMOD; REGISTRATION NO/DATE: EU/1/19/1414 (MITTEILUNG) 20200115 |
| 2379069 | PA2020513 | Lithuania | Start Trial | PRODUCT NAME: SIPONIMODAS; REGISTRATION NO/DATE: EU/1/19/1414 20200113 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
