Company names starting with "T"

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.

Takeda Pharmaceuticals U.S.A., Inc.
Elaprase (Injection) (Intravenous) idursulfase
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glycosaminoglycan (GAG)-specific enzyme
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125151  Prod. No.: 001 Rx (6MG/3ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 24, 2013Orphan Designation: Long term enzyme replacement therapy for patients with mucopolysaccharidosis II (Hunter Syndrome)
Approved Labeled Indication: Indicated for patients with Hunter syndrome (mucopolysaccharidosis II, MPS II). Idursulfase has been shown to improve walking capacity in these patients

Takeda Pharmaceuticals U.S.A., Inc.
Kalbitor (Injection) (Subcutaneous) ecallantide
Drug Classes: Immunological Agents:Angioedema Agents == plasma kallikrein inhibitor
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125277  Prod. No.: 001 Rx (10MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 1, 2016Orphan Designation: Treatment of angioedema
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema in patients 16 years of age and older
Exclusivity Type: Orphan Drug ExclusivityMar 28, 2021Orphan Designation: Treatment of angioedema
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema (HAE) in patients 12 years of age and older
Exclusivity Protected Indication: Treatment of acute attacks of hereditary angioedema (HAE) in patients 12 through 15 years of age.

Takeda Pharmaceuticals U.S.A., Inc.
Takhzyro (Injection) (Subcutaneous) lanadelumab-flyo
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

Theratechnologies Inc.
Trogarzo (Injection) (Intravenous) ibalizumab-uiyk
NDA Applicant: Theratechnologies Inc.      BLA No.: 761065  Prod. No.: 001 Rx (200MG/1.33ML (150MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 6, 2025Orphan Designation: Treatment of HIV-1 infection in treatment experienced adult patients with documented multi-antiretroviral class resistance and evidence of HIV-1 replication despite ongoing antiretroviral therapy
Approved Labeled Indication: TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
Exclusivity Protected Indication: TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.


Last edited: 15 November 2022
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