Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| 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. |
Kanuma (Injection) (Intravenous) sebelipase alfa
NDA Applicant: Alexion Pharmaceuticals, Inc. BLA No.: 125561 Prod. No.: 001 Rx (20MG/10ML (2MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 8, 2022 | Orphan 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)
NDA Applicant: CSL Behring GmbH BLA No.: 125421 Prod. No.: 001 Rx (500IU); 002 Rx (1000IU)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 29, 2020 | Orphan 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 Exclusivity | Dec 13, 2020 | Orphan 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
NDA Applicant: Merck Sharp & Dohme LLC BLA No.: 125514 Prod. No.: 002 Rx (100MG/4ML (25MG/ML)) BLA No.: 125514 Prod. No.: 001 Disc (50MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 4, 2021 | Orphan 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 Exclusivity | Dec 18, 2022 | Orphan 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 Exclusivity | Mar 14, 2024 | Orphan 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 Exclusivity | Sep 22, 2024 | Orphan 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 Exclusivity | Jun 13, 2025 | Orphan 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 Exclusivity | Nov 9, 2025 | Orphan 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 Exclusivity | Dec 19, 2025 | Orphan 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 Exclusivity | Feb 15, 2026 | Orphan 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 Exclusivity | Jul 30, 2026 | Orphan 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 Exclusivity | May 5, 2028 | Orphan 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 |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 3, 2028 | Orphan Designation: Treatment of Stage IIB through IV malignant melanoma Approved Labeled Indication: adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB, IIC, or III melanoma following complete resection Exclusivity Protected Indication: adjuvant treatment of adult and pediatric (12 years and older) patients with Stage IIB or IIC melanoma following complete resection, and adjuvant treatment of pediatric (12 years and older) patients with Stage III melanoma following complete resection |
Kimmtrak (Injection) (Intravenous) tebentafusp-tebn
NDA Applicant: Immunocore Limited BLA No.: 761228 Prod. No.: 001 Rx (100MCG/0.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jan 25, 2029 | Orphan Designation: Treatment of uveal melanoma Approved Labeled Indication: treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma Exclusivity Protected Indication: treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma |
Kineret (Injection) (Subcutaneous) anakinra
NDA Applicant: Swedish Orphan Biovitrum AB (publ) BLA No.: 103950 Prod. No.: 001 Rx (100MG/0.67ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 21, 2019 | Orphan Designation: Treatment of cryopyrin-associated periodic syndromes Approved Labeled Indication: Treatment of neonatal-onset multisystem inflammatory disease (NOMID) |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 18, 2027 | Orphan 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
NDA Applicant: Horizon Therapeutics Ireland DAC BLA No.: 125293 Prod. No.: 001 Rx (8MG/1ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 14, 2017 | Orphan 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
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)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | May 1, 2025 | Orphan 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. |
| Exclusivity Type: Orphan Drug Exclusivity | May 27, 2029 | Orphan Designation: Treatment of follicular lymphoma Approved Labeled Indication: Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy |