Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 25, 2018 | Orphan Designation: Treatment of high risk Stage II, Stage III, and Stage IV melanoma Approved Labeled Indication: Treatment of unresectable or metastatic melanoma |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 28, 2022 | Orphan Designation: Treatment of high risk Stage II, Stage III, and Stage IV melanoma Approved Labeled Indication: For the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection including total lymphadenectomy. Exclusivity Protected Indication: For the adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm, who have undergone complete resection including total lymphadenectomy. |
| Exclusivity Type: Orphan Drug Exclusivity | Jul 21, 2024 | Orphan Designation: Treatment of high risk Stage II, Stage III, and Stage IV melanoma Approved Labeled Indication: treatment of unresectable or metastatic melanoma in adults and pediatric patients (12 years and older) Exclusivity Protected Indication: treatment of unresectable or metastatic melanoma in pediatric patients (12 years and older). |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 2, 2027 | Orphan Designation: This Orphan Designation could not be obtained via our automated process due to a trademark mismatch between the Purple Book and the FDA's "Orphan Drug Designations and Approvals" search engine. Please use the FDA's search engine to manually look up the orphan designation. |
Yescarta (Injection) (Intravenous) axicabtagene ciloleucel
NDA Applicant: Kite Pharma Inc. BLA No.: 125643 Prod. No.: 001 Rx (2 _ 10^6 CAR-POSITIVE VIABLE T CELLS PER KG OF BODY WEIGHT)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Oct 18, 2024 | Orphan Designation: Treatment of primary mediastinal B-cell lymphoma. Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 18, 2024 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma) |
| Exclusivity Type: Orphan Drug Exclusivity | Oct 18, 2024 | Orphan Designation: Treatment of follicular lymphoma. Approved Labeled Indication: Treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy, treatment of adult patients with relapsed or refractory DLBCL arising from follicular lymphoma after two or more lines of systemic therapy, and treatment of adult patients with relapsed or refractory primary mediastinal B-cell lymphoma after two or more lines of systemic therapy (not including treatment of patients with primary central nervous system lymphoma) |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 5, 2028 | Orphan Designation: Treatment of follicular lymphoma. Approved Labeled Indication: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy, excluding patients with diffuse large B-cell lymphoma arising from follicular lymphoma. |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2029 | Orphan Designation: Treatment of follicular lymphoma. Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Exclusivity Protected Indication: treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, treatment of adult patients with DLBCL arising from follicular lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult patients with primary mediastinal B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (not including treatment of patients with primary central nervous system lymphoma and excluding patients covered by the indication that received marketing approval on October 18, 2017 for Yescarta) |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2029 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Exclusivity Protected Indication: treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, treatment of adult patients with DLBCL arising from follicular lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult patients with primary mediastinal B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (not including treatment of patients with primary central nervous system lymphoma and excluding patients covered by the indication that received marketing approval on October 18, 2017 for Yescarta) |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 1, 2029 | Orphan Designation: Treatment of primary mediastinal B-cell lymphoma. Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy. Limitations of Use: Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. Exclusivity Protected Indication: treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, treatment of adult patients with DLBCL arising from follicular lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy, and treatment of adult patients with primary mediastinal B-cell lymphoma that is refractory to first-line chemoimmunotherapy or that relapses within 12 months of first-line chemoimmunotherapy (not including treatment of patients with primary central nervous system lymphoma and excluding patients covered by the indication that received marketing approval on October 18, 2017 for Yescarta) |