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 | 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. |
Octagam (Injection) (Intravenous) Immune Globulin Intravenous (Human)
NDA Applicant: Octapharma Pharmazeutika Produktionsges.m.b.H. BLA No.: 125062 Prod. No.: 001 Rx (5% 5.0G); 002 Rx (5% 1.0G); 003 Rx (5% 10G); 004 Rx (5% 2.5G); 005 Rx (5% 25G); 006 Rx (10% 20G); 007 Rx (10% 5G); 008 Rx (10% 2G); 009 Rx (10% 10G)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 15, 2028 | Orphan Designation: Treatment of dermatomyositis Approved Labeled Indication: Treatment of dermatomyositis in adults Exclusivity Protected Indication: Treatment of dermatomyositis in adults |
OMISIRGE (For Injection) (Intravenous) omidubicel-onlv
NDA Applicant: Gamida Cell Ltd. BLA No.: 125738 Prod. No.: 001 Rx (>4.0x10^8 total viable cells, >2.4x10^7 CD3+ cells with 41mL dil sol); 002 Rx (>8.0x10^8 total viable cells, >8.7% CD34+ cells, >9.2x10^7 CD34+ cells with 81mL dil so)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 17, 2030 | Orphan Designation: Enhancement of cell engraftment and immune reconstitution in patients receiving hematopoietic stem cell transplant Approved Labeled Indication: for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection Exclusivity Protected Indication: for use in adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection |
Oncaspar (Injection) (Intravenous, Intramuscular) pegaspargase
NDA Applicant: Servier Pharmaceuticals LLC BLA No.: 103411 Prod. No.: 001 Rx (3,750IU/5ML(750IU/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 1, 2001 | 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. |
Ontak (Injection) (Intravenous) denileukin diftitox
NDA Applicant: Eisai, Incorporated BLA No.: 103767 Prod. No.: 001 Disc (150MCG/ML (300MCG/2ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 5, 2006 | Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma Approved Labeled Indication: Treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor. |
Opdivo (Injection) (Intravenous) nivolumab
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 125554 Prod. No.: 001 Rx (40MG/4ML (10MG/ML)); 002 Rx (100MG/10ML (10MG/ML)); 003 Rx (240MG/24ML (10MG/ML)); 004 Rx (120MG/12ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 22, 2021 | Orphan Designation: Treatment of Stage IIb to IV 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 Protected 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 | May 17, 2023 | Orphan Designation: Treatment of Hodgkin lymphoma Approved Labeled Indication: Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin Exclusivity Protected Indication: Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 25, 2024 | Orphan Designation: Treatment of Hodgkin lymphoma Approved Labeled Indication: Treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin; or 3 or more lines of systemic therapy that includes autologous HSCT. Exclusivity Protected Indication: Treatment of adult patients with Classical Hodgkin lymphoma that has relapsed or progressed after 3 or more lines of systemic therapy that includes autologous HSCT, not including any overlap with the orphan exclusivity awarded for the 2016 marketing approval of nivolumab for the treatment of adult patients with classical Hodgkin lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin. |
| Exclusivity Type: Orphan Drug Exclusivity | Dec 20, 2024 | Orphan Designation: Treatment of Stage IIb to IV melanoma Approved Labeled Indication: Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection Exclusivity Protected Indication: Adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection |
| Exclusivity Type: Orphan Drug Exclusivity | Jun 10, 2027 | Orphan Designation: Treatment of esophageal cancer Approved Labeled Indication: Opdivo (nivolumab) indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. Exclusivity Protected Indication: For the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy. |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 16, 2028 | Orphan Designation: Treatment of gastric cancer and gastro-esophageal junction cancer Approved Labeled Indication: in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma Exclusivity Protected Indication: treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma |
| Exclusivity Type: Orphan Drug Exclusivity | Apr 16, 2028 | Orphan Designation: Treatment of esophageal cancer Approved Labeled Indication: in combination with fluoropyrimidine- and platinum-containing chemotherapy for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma Exclusivity Protected Indication: treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma |
| Exclusivity Type: Orphan Drug Exclusivity | May 20, 2028 | Orphan Designation: Treatment of gastric cancer and gastro-esophageal junction cancer Approved Labeled Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT) Exclusivity Protected Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT) |
| Exclusivity Type: Orphan Drug Exclusivity | May 20, 2028 | Orphan Designation: Treatment of esophageal cancer Approved Labeled Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT) Exclusivity Protected Indication: adjuvant treatment of completely resected esophageal or gastroesophageal junction cancer with residual pathologic disease in patients who have received neoadjuvant chemoradiotherapy (CRT) |
| Exclusivity Type: Orphan Drug Exclusivity | May 27, 2029 | Orphan Designation: Treatment of esophageal cancer Approved Labeled Indication: In combination with ipilimumab, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) Exclusivity Protected Indication: First-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) |
| Exclusivity Type: Orphan Drug Exclusivity | May 27, 2029 | Orphan Designation: Treatment of esophageal cancer Approved Labeled Indication: In combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) Exclusivity Protected Indication: First-line treatment of adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC) |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 15, 2030 | Orphan Designation: Treatment of Stage IIb to IV melanoma Approved Labeled Indication: As a single agent or in combination with ipilimumab, for the treatment of adult and pediatric patients 12 years and older with unresectable or metastatic melanoma Exclusivity Protected Indication: Treatment of pediatric patients 12 years and older with unresectable or metastatic melanoma |
| Exclusivity Type: Orphan Drug Exclusivity | Feb 15, 2030 | Orphan Designation: Treatment of Stage IIb to IV melanoma Approved Labeled Indication: adjuvant treatment of adult and pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection Exclusivity Protected Indication: adjuvant treatment of pediatric patients 12 years and older with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection |
Opdualag (Injection) (Intravenous) nivolumab and relatlimab-rmbw
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 761234 Prod. No.: 001 Rx (240MG, 80MG/20ML (12MG, 4MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 18, 2029 | Orphan Designation: Treatment of stage IIb to IV melanoma Approved Labeled Indication: Treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma Exclusivity Protected Indication: Treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma |
Orencia (For Injection) (Intravenous; Subcutaneous) abatacept
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 125118 Prod. No.: 001 Rx (250MG); 002 Rx (125MG/ML); 003 Rx (125MG/ML); 004 Rx (50MG/0.4ML); 005 Rx (87.5MG/0.7ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 15, 2028 | Orphan Designation: Prevention of graft versus host disease Approved Labeled Indication: prophylaxis of acute graft versus host disease (aGVHD), in combination with a calcineurin inhibitor and methotrexate, in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor Exclusivity Protected Indication: prophylaxis of acute graft versus host disease (aGVHD) in adults and pediatric patients 2 years of age and older undergoing hematopoietic stem cell transplantation (HSCT) from a matched or 1 allele-mismatched unrelated-donor |
Oxervate (Solution) (Topical) cenegermin-bkbj
NDA Applicant: Dompˇ farmaceutici S.p.A. BLA No.: 761094 Prod. No.: 001 Rx (0.002% (20MCG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 22, 2025 | Orphan Designation: Treatment of neurotrophic keratitis Approved Labeled Indication: Treatment of neurotrophic keratitis Exclusivity Protected Indication: Treatment of neurotrophic keratitis |