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.
Autoplex, Feiba Nf, Feiba Vh (For Injection) (Intravenous) Anti-Inhibitor Coagulant Complex
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 101447  Prod. No.: 003 Rx (1000U); 004 Rx (500U); 005 Rx (2500U) BLA No.: 101447  Prod. No.: 001 Disc (1000IU); 002 Disc (500IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 16, 2020Orphan 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.

Takeda Pharmaceuticals U.S.A., Inc.
Ceprotin (For Injection) (Intravenous) Protein C Concentrate (Human)
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125234  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 30, 2014Orphan Designation: For replacement therapy in congenital protein C deficiency for the prevention and treatment of thrombosis, pulmonary emboli, and purpura fulminans.
Approved Labeled Indication: Prevention and treatment of venous thrombosis and purpura fulminans

Takeda Pharmaceuticals U.S.A., Inc.
Cinryze (For Injection) (Intravenous) C1 Esterase Inhibitor (Human)
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125267  Prod. No.: 001 Rx (500U)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 10, 2015Orphan Designation: Treatment of angioedema
Approved Labeled Indication: Routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE)
Exclusivity Type: Orphan Drug ExclusivityJun 20, 2025Orphan Designation: Treatment of angioedema
Approved Labeled Indication: CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE).
Exclusivity Protected Indication: CINRYZE (C1 esterase inhibitor [human]) is indicated for routine prophylaxis against angioedema attacks in pediatric patients ages 6-11 with Hereditary Angioedema (HAE).

Takeda Pharmaceuticals U.S.A., Inc.
Elaprase (Injection) (Intravenous) idursulfase
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.
Gammagard Liquid (Injection) (Intravenous, Subcutaneous) Immune Globulin Infusion (Human)
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125105  Prod. No.: 001 Rx (10% MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 22, 2019Orphan Designation: Treatment of multifocal motor neuropathy
Approved Labeled Indication: Maintenance therapy to improve muscle strength and disability in adult patients with Multifocal Motor Neuropathy (MMN).

Takeda Pharmaceuticals U.S.A., Inc.
Kalbitor (Injection) (Subcutaneous) ecallantide
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.
Natpara (For Injection) (Subcutaneous) parathyroid hormone
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125511  Prod. No.: 001 Rx (25MCG); 002 Rx (50MCG); 003 Rx (75MCG); 004 Rx (100MCG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 23, 2022Orphan Designation: Treatment of hypoparathyroidism
Approved Labeled Indication: An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism
Exclusivity Protected Indication: An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism

Takeda Pharmaceuticals U.S.A., Inc.
Obizur (For Injection) (Intravenous) Antihemophilic Factor (Recombinant), Porcine Sequence
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125512  Prod. No.: 001 Rx (500U)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 23, 2021Orphan Designation: Treatment and prevention of episodic bleeding in patients with inhibitor antibodies to human coagulation factor VIII
Approved Labeled Indication: Treatment of bleeding episodes in adults with acquired hemophilia A.
Exclusivity Protected Indication: Treatment of bleeding episodes in adults with acquired hemophilia A.

Takeda Pharmaceuticals U.S.A., Inc.
Rixubis (For Injection) (Intravenous) Coagulation Factor IX (Recombinant)
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125446  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU); 003 Rx (250IU); 004 Rx (3000IU); 005 Rx (2000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 12, 2021Orphan 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.

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)); 002 Rx (300MG/2ML (150MG/ML)); 003 Rx (150MG/1ML (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
Exclusivity Type: Orphan Drug ExclusivityFeb 3, 2030Orphan 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

Takeda Pharmaceuticals U.S.A., Inc.
Vonvendi (For Injection) (Intravenous) von Willebrand factor (Recombinant)
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc.      BLA No.: 125577  Prod. No.: 001 Rx (1300IU); 002 Rx (650IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 28, 2029Orphan Designation: Treatment of von Willebrand disease
Approved Labeled Indication: For use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 VWD receiving on-demand therapy
Exclusivity Protected Indication: For use in adults (age 18 and older) diagnosed with von Willebrand disease (VWD) for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 VWD receiving on-demand therapy

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: 19 August 2023
© 2001-2023 Bruce A. Pokras, All rights reserved worldwide