Ozanimod - Generic Drug Details
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Generic filers with tentative approvals for OZANIMOD
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Start Trial | ⤷ Start Trial | 0.23MG | CAPSULE |
| ⤷ Start Trial | ⤷ Start Trial | 0.46MG | CAPSULE |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
US Patents and Regulatory Information for Ozanimod
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-002 | Mar 25, 2020 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-001 | Mar 25, 2020 | RX | Yes | No | 8,481,573 | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-001 | Mar 25, 2020 | RX | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-003 | Mar 25, 2020 | RX | Yes | Yes | 10,239,846 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-002 | Mar 25, 2020 | RX | Yes | No | 9,382,217 | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bristol | ZEPOSIA | ozanimod hydrochloride | CAPSULE;ORAL | 209899-001 | Mar 25, 2020 | RX | Yes | No | 9,382,217 | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
