Regulatory Exclusivity: NEW INDICATION
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Drugs with New Indication Regulatory Exclusivity
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| Applicant | Tradename | Generic Name | NDA | Approval Date | Type | Patent No. | Patent Expiration | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|
| Incyte Corp | OPZELURA | ruxolitinib phosphate | 215309 | Sep 21, 2021 | RX | 12,233,067 | ⤷ Start Trial | ⤷ Start Trial | INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| Incyte Corp | OPZELURA | ruxolitinib phosphate | 215309 | Sep 21, 2021 | RX | 11,510,923 | ⤷ Start Trial | ⤷ Start Trial | INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| Incyte Corp | OPZELURA | ruxolitinib phosphate | 215309 | Sep 21, 2021 | RX | 11,602,536 | ⤷ Start Trial | ⤷ Start Trial | INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| Incyte Corp | OPZELURA | ruxolitinib phosphate | 215309 | Sep 21, 2021 | RX | 11,590,138 | ⤷ Start Trial | ⤷ Start Trial | INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| Incyte Corp | OPZELURA | ruxolitinib phosphate | 215309 | Sep 21, 2021 | RX | 11,590,137 | ⤷ Start Trial | ⤷ Start Trial | INDICATED FOR THE TOPICAL TREATMENT OF NONSEGMENTAL VITILIGO IN ADULT AND PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER |
| >Applicant | >Tradename | >Generic Name | >NDA | >Approval Date | >Type | >Patent No. | >Patent Expiration | >Exclusivity Expiration | >Patented / Exclusive Use |
