Regulatory Exclusivity Expiring in 2022
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Drugs with Regulatory Exclusivity Expiring in 2022
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
---|---|---|---|---|---|---|---|---|---|---|---|
Redhill | TALICIA | amoxicillin; omeprazole magnesium; rifabutin | CAPSULE, DELAYED RELEASE;ORAL | 213004-001 | Nov 1, 2019 | RX | Yes | Yes | ⤷ Try a Trial | NEW PRODUCT | |
Lupin | SOLOSEC | secnidazole | GRANULE;ORAL | 209363-001 | Sep 15, 2017 | RX | Yes | Yes | ⤷ Try a Trial | NEW CHEMICAL ENTITY | |
Astellas | CRESEMBA | isavuconazonium sulfate | CAPSULE;ORAL | 207500-002 | Nov 22, 2022 | RX | Yes | No | ⤷ Try a Trial | PEDIATRIC EXCLUSIVITY | |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |