Regulatory Exclusivity Expiring in 2025
Drugs with Regulatory Exclusivity Expiring in 2025
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Exclusivity Expiration | Patented / Exclusive Use |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-001 | Jun 28, 2006 | AB | RX | Yes | No | ⤷ Start Trial | INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-002 | Jun 28, 2006 | AB | RX | Yes | No | ⤷ Start Trial | INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-003 | Jun 28, 2006 | AB | RX | Yes | No | ⤷ Start Trial | INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-005 | Oct 28, 2010 | AB | RX | Yes | No | ⤷ Start Trial | INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-004 | May 30, 2008 | AB | RX | Yes | Yes | ⤷ Start Trial | INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY |
| Bristol Myers Squibb | SPRYCEL | dasatinib | TABLET;ORAL | 021986-006 | Oct 28, 2010 | AB | RX | Yes | No | ⤷ Start Trial | INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) IN COMBINATION WITH CHEMOTHERAPY |
| Incyte Corp | JAKAFI | ruxolitinib phosphate | TABLET;ORAL | 202192-001 | Nov 16, 2011 | RX | Yes | No | ⤷ Start Trial | REVISIONS TO SECTION 8.4 OF THE LABELING TO INCLUDE THE RESULTS OF STUDY INCB 18424-269 | |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Exclusivity Expiration | >Patented / Exclusive Use |
