Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, all expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 23, 2025 | Orphan Designation: Treatment of angioedema Approved Labeled Indication: Prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older Exclusivity Protected Indication: Prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients 12 years and older |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 3, 2030 | Orphan Designation: Treatment of angioedema Approved Labeled Indication: prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 2 years and older Exclusivity Protected Indication: prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged 2 years to less than 12 years |
laronidase (Injection) (Intravenous) Aldurazyme
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 125058 Prod. No.: 001 Rx (2.9MG/5ML (0.58MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 30, 2010 | Orphan Designation: Treatment of patients with mucopolysaccharidosis-I. Approved Labeled Indication: Treatment for patients with Hurler and Hurler-Scheie forms of Mucopolysaccharidosis I (MPS I) and for patients with the Scheie form who have moderate to severe symptoms |
lisocabtagene maraleucel (Injection) (Intravenous) Breyanzi
NDA Applicant: Juno Therapeutics, Inc. a Bristol Myer-Squibb Company BLA No.: 125714 Prod. No.: 001 Rx (4.6ML/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 5, 2028 | Orphan Designation: Treatment of primary mediastinal 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 (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma) after two or more lines of systemic therapy; treatment of adult patients with relapsed or refractory primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy; and treatment of adult patients with relapsed or refractory follicular lymphoma grade 3B after two or more lines of systemic therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 5, 2028 | 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 (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B 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 primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy; and treatment of adult patients with relapsed or refractory follicular lymphoma grade 3B after two or more lines of systemic therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 5, 2028 | Orphan Designation: Treatment of follicular lymphoma (FL) 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 (including DLBCL arising from indolent lymphoma), high-grade B cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B 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 primary mediastinal large B-cell lymphoma after two or more lines of systemic therapy; and treatment of adult patients with relapsed or refractory follicular lymphoma grade 3B after two or more lines of systemic therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 24, 2029 | Orphan Designation: Treatment of follicular lymphoma (FL) Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. Exclusivity Protected Indication: Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (not including treatment of patients with primary central nervous system (CNS) lymphoma and excluding patients covered by the indication that received marketing approval on February 5, 2021 for Breyanzi) |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 24, 2029 | Orphan Designation: Treatment of primary mediastinal large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. Exclusivity Protected Indication: Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (not including treatment of patients with primary central nervous system (CNS) lymphoma and excluding patients covered by the indication that received marketing approval on February 5, 2021 for Breyanzi) |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 24, 2029 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: Treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system (CNS) lymphoma. Exclusivity Protected Indication: Treatment of adult patients with diffuse large B-cell lymphoma (DLBCL) , primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age (not including treatment of patients with primary central nervous system (CNS) lymphoma and excluding patients covered by the indication that received marketing approval on February 5, 2021 for Breyanzi) |
loncastuximab tesirine-lpyl (For Injection) (Intravenous) Zynlonta
NDA Applicant: ADC Therapeutics SA BLA No.: 761196 Prod. No.: 001 Rx (10MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 23, 2028 | 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, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy |
luspatercept-aamt (For Injection) (Subcutaneous) Reblozyl
NDA Applicant: Celgene Corporation, a Bristol-Myers Squibb Company BLA No.: 761136 Prod. No.: 001 Rx (25MG/VIAL); 002 Rx (75MG/VIAL)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 8, 2026 | Orphan Designation: Treatment of B-thalassemia Approved Labeled Indication: REBLOZYL is indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. Exclusivity Protected Indication: Indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 3, 2027 | Orphan Designation: Treatment of myelodysplastic syndrome Approved Labeled Indication: REBLOZYL is indicated for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T). Exclusivity Protected Indication: For the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) |