Regulatory Exclusivity: NEW PATIENT POPULATION
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Drugs with New Patient Population Regulatory Exclusivity
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Pharmacyclics Llc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-002 | Dec 20, 2017 | RX | Yes | No | ⤷ Start Trial | NEW PATIENT POPULATION | |
| Pharmacyclics Llc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | ⤷ Start Trial | NEW PATIENT POPULATION | |
| Pharmacyclics Llc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-001 | Feb 16, 2018 | RX | Yes | No | ⤷ Start Trial | NEW PATIENT POPULATION | |
| Pharmacyclics Llc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-002 | Feb 16, 2018 | RX | Yes | No | ⤷ Start Trial | NEW PATIENT POPULATION | |
| Pharmacyclics Llc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-003 | Feb 16, 2018 | RX | Yes | Yes | ⤷ Start Trial | NEW PATIENT POPULATION | |
| Pharmacyclics Llc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-004 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Start Trial | NEW PATIENT POPULATION | |
| Pfizer | CIBINQO | abrocitinib | TABLET;ORAL | 213871-001 | Jan 14, 2022 | RX | Yes | No | ⤷ Start Trial | NEW PATIENT POPULATION | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
