Generic names starting with "L"

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.


lanadelumab-flyo (Injection) (Subcutaneous) Takhzyro
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 761090  Prod. No.: 001 Rx (300MG/2ML (150MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 23, 2025Orphan 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

laronidase (Injection) (Intravenous) Aldurazyme
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glycosaminoglycan (GAG)-specific enzyme
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 125058  Prod. No.: 001 Rx (2.9MG/5ML (0.58MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 30, 2010Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 5, 2028Orphan 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 ExclusivityFeb 5, 2028Orphan 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 ExclusivityFeb 5, 2028Orphan 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

loncastuximab tesirine-lpyl (For Injection) (Intravenous) Zynlonta
NDA Applicant: ADC Therapeutics SA      BLA No.: 761196  Prod. No.: 001 Rx (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 23, 2028Orphan 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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 8, 2026Orphan 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 ExclusivityApr 3, 2027Orphan 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)



Last edited: 15 November 2022
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