Regulatory Exclusivity: NEW INDICATION
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Drugs with New Indication Regulatory Exclusivity
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Incyte Corp | OPZELURA | ruxolitinib phosphate | CREAM;TOPICAL | 215309-001 | Sep 21, 2021 | RX | Yes | Yes | ⤷ Get Started Free | INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER | |
| Beone Medicines Usa | BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217-001 | Nov 14, 2019 | DISCN | Yes | No | ⤷ Get Started Free | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) | |
| Beone Medicines Usa | BRUKINSA | zanubrutinib | TABLET;ORAL | 218785-001 | Jun 10, 2025 | RX | Yes | Yes | ⤷ Get Started Free | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) | |
| Seagen | TUKYSA | tucatinib | TABLET;ORAL | 213411-001 | Apr 17, 2020 | RX | Yes | No | ⤷ Get Started Free | TUCATINIB IN COMBINATION WITH TRASTUZUMAB FOR THE TREATMENT OF ADULT PATIENTS WITH RAS WILD-TYPE, HER2-POSITIVE, UNRESECTABLE OR METASTATIC COLORECTAL CANCER THAT HAS PROGRESSED FOLLOWING TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
