Tradenames starting with "K"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


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.

Kanuma (Injection) (Intravenous) sebelipase alfa
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysosomal cholesteryl ester-specific enzyme == hydrolytic lysosomal triacylglycerol-specific enzyme
NDA Applicant: Alexion Pharmaceuticals, Inc.      BLA No.: 125561  Prod. No.: 001 Rx (20MG/10ML (2MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 8, 2022Orphan Designation: Treatment of lysosomal acid lipase deficiency
Approved Labeled Indication: Indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency
Exclusivity Protected Indication: Indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency

Kcentra (For Injection) (Intravenous) Prothrombin Complex Concentrate (Human)
Drug Classes: blood coagulation factor
NDA Applicant: CSL Behring GmbH      BLA No.: 125421  Prod. No.: 001 Rx (500IU); 002 Rx (1000IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityApr 29, 2020Orphan Designation: Treatment of patients needing urgent reversal of Vitamin K antagonist therapy for treatment of major bleeding and/or surgical procedures
Approved Labeled Indication: Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.
Exclusivity Protected Indication: Urgent reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding.
Exclusivity Type: Orphan Drug ExclusivityDec 13, 2020Orphan Designation: Treatment of patients needing urgent reversal of Vitamin K antagonist therapy for treatment of major bleeding and/or surgical procedures
Approved Labeled Indication: Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (VKA, e.g., warfarin) therapy in adult patients with acute major bleeding or need for an urgent surgery/invasive procedure.
Exclusivity Protected Indication: Urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist therapy (VKA, e.g., warfarin) in adult patients with the need for urgent surgery/invasive procedure.

Keytruda (For Injection) (Intravenous) pembrolizumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate == human programmed death receptor-1 (PD-1)-blocking antibody
NDA Applicant: Merck Sharp & Dohme Corp.      BLA No.: 125514  Prod. No.: 002 Rx (100MG/4ML (25MG/ML)) BLA No.: 125514  Prod. No.: 001 Disc (50MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 4, 2021Orphan Designation: Treatment of Stage IIB through IV malignant melanoma
Approved Labeled Indication: Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
Exclusivity Type: Orphan Drug ExclusivityDec 18, 2022Orphan Designation: Treatment of Stage IIB through IV malignant melanoma
Approved Labeled Indication: Treatment of patients with unresectable or metastatic melanoma.
Exclusivity Protected Indication: Initial treatment of patients with unresectable or metastatic melanoma
Exclusivity Type: Orphan Drug ExclusivityMar 14, 2024Orphan Designation: Treatment of Hodgkin lymphoma.
Approved Labeled Indication: Treatment for adult and pediatric patients with refractory classical Hodgkin Lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy.
Exclusivity Protected Indication: Treatment of adult and pediatric patients with refractory classical Hodgkin Lymphoma, or who have relapsed after 3 or more prior lines of therapy.
Exclusivity Type: Orphan Drug ExclusivitySep 22, 2024Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction adenocarcinoma
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) =1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy.
Exclusivity Protected Indication: Treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 [Combined Positive Score (CPS) >or =1] as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu targeted therapy excluding microsatellite instability-high or mismatch repair deficient gastric or gastroesophageal adenocarcinomas that have progressed and have no satisfactory alternative treatment options.
Exclusivity Type: Orphan Drug ExclusivityJun 13, 2025Orphan Designation: Treatment of primary mediastinal B cell lymphoma.
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy
Exclusivity Protected Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy
Exclusivity Type: Orphan Drug ExclusivityNov 9, 2025Orphan Designation: Treatment of hepatocellular carcinoma (HCC)
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Exclusivity Protected Indication: KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Exclusivity Type: Orphan Drug ExclusivityDec 19, 2025Orphan Designation: Treatment of Merkel cell carcinoma
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma
Exclusivity Protected Indication: KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma
Exclusivity Type: Orphan Drug ExclusivityFeb 15, 2026Orphan Designation: Treatment of Stage IIB through IV malignant melanoma
Approved Labeled Indication: KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Exclusivity Protected Indication: KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.
Exclusivity Type: Orphan Drug ExclusivityJul 30, 2026Orphan Designation: Treatment of esophageal carcinoma
Approved Labeled Indication: KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS =10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Exclusivity Protected Indication: Indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] =10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.
Exclusivity Type: Orphan Drug ExclusivityMay 5, 2028Orphan Designation: Treatment of gastric cancer, including gastroesophageal junction adenocarcinoma
Approved Labeled Indication: in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma
Exclusivity Protected Indication: for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma, excluding patients covered by Keytruda's previous indication for gastric or GEJ adenocarcinoma approved on September 22, 2017

Kineret (Injection) (Subcutaneous) anakinra
Drug Classes: Immunological Agents:Immunological Agents, Other == interleukin-1 (IL-1) receptor antagonist
NDA Applicant: Swedish Orphan Biovitrum AB (publ)      BLA No.: 103950  Prod. No.: 001 Rx (100MG/0.67ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 21, 2019Orphan Designation: Treatment of cryopyrin-associated periodic syndromes
Approved Labeled Indication: Treatment of neonatal-onset multisystem inflammatory disease (NOMID)
Exclusivity Type: Orphan Drug ExclusivityDec 18, 2027Orphan Designation: Treatment of Deficiency of IL-1 Receptor Antagonist
Approved Labeled Indication: treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)
Exclusivity Protected Indication: treatment of Deficiency of Interleukin-1 Receptor Antagonist (DIRA)

Krystexxa (Injection) (Intravenous) pegloticase
Drug Classes: Antigout Agents
NDA Applicant: Horizon Therapeutics Ireland DAC      BLA No.: 125293  Prod. No.: 001 Rx (8MG/1ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 14, 2017Orphan Designation: To control the clinical consequences of hyperuricemia in patients with severe gout in whom conventional therapy is contraindicated or has been ineffective
Approved Labeled Indication: Treatment of chronic gout in adult patients refractory to conventional treatment

Kymriah (Injection) (Intravenous) Tisagenlecleucel
Drug Classes: CD19-directed genetically modified autologous T-cells
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 125646  Prod. No.: 001 Rx (0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 1, 2025Orphan Designation: Treatment of diffuse large B-cell lymphoma
Approved Labeled Indication: KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma
Exclusivity Protected Indication: For treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma after two or more lines of systemic therapy.



Last edited: 15 November 2022
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