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 | Dec 16, 2020 | 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. |
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)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Mar 30, 2014 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Oct 10, 2015 | Orphan Designation: Treatment of angioedema Approved Labeled Indication: Routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE) |
Exclusivity Type: Orphan Drug Exclusivity | Jun 20, 2025 | Orphan 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))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jul 24, 2013 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jun 22, 2019 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Dec 1, 2016 | Orphan 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 Exclusivity | Mar 28, 2021 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jan 23, 2022 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Oct 23, 2021 | Orphan 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)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Sep 12, 2021 | 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. |
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))
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 |
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)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Jan 28, 2029 | Orphan 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))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Type: Orphan Drug Exclusivity | Mar 6, 2025 | Orphan 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. |