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: Ref. Product Exclusivity | May 1, 2031 |
Sanofi Pasteur Inc.
Menquadfi (Injection) (Intramuscular) Meningococcal (Groups A, C, Y, W) Conjugate Vaccine
NDA Applicant: Sanofi Pasteur Inc. BLA No.: 125701 Prod. No.: 001 Rx (0.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Jan 14, 2017 |
Sanofi-Aventis U.S. LLC
Elitek (For Injection) (Intravenous) rasburicase
NDA Applicant: Sanofi-Aventis U.S. LLC BLA No.: 103946 Prod. No.: 001 Rx (1.5MG); 002 Rx (7.5MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jul 12, 2009 | Orphan Designation: Treatment of malignancy-associated or chemotherapy-induced hyperuricemia. Approved Labeled Indication: Initial management of plasma uric acid levels in pediatric patients with leukemia,lymphoma, and solid tumor malignancies who are receiving anti-cancer therapy expected to result in tumor lysis and subsequent elevation of plasma uric acid. |
Sanofi-Aventis U.S. LLC
Sarclisa (Injection) (Intravenous) isatuximab-irfc
NDA Applicant: Sanofi-Aventis U.S. LLC BLA No.: 761113 Prod. No.: 001 Rx (100MG/5ML (20MG/ML)); 002 Rx (500MG/25ML (20MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 2, 2027 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: SARCLISA is indicated, in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. Exclusivity Protected Indication: Indicated in combination with pomalidomide and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 31, 2028 | Orphan Designation: Treatment of multiple myeloma Approved Labeled Indication: in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 prior line of therapy, and for treatment of adult patients with relapsed or refractory multiple myeloma who have received 2 to 3 prior therapies excluding patients covered by the indication approved on March 2, 2020 |
Sarepta Therapeutics, Inc.
ELEVIDYS (Suspension) (Intravenous) delandistrogene moxeparvovec-rokl
NDA Applicant: Sarepta Therapeutics, Inc. BLA No.: 125781 Prod. No.: 001 Rx (1.33 _10E14 vector genomes (vg)/kg/bodyweight(bw))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 22, 2030 | Orphan Designation: Treatment of Duchenne Muscular Dystrophy Approved Labeled Indication: treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene Exclusivity Protected Indication: treatment of ambulatory pediatric patients aged 4 through 5 years with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene |
Seagen Inc.
Adcetris (For Injection) (Intravenous) brentuximab vedotin
NDA Applicant: Seagen Inc. BLA No.: 125388 Prod. No.: 001 Rx (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11505593 Anti-VEGF protein compositions and methods for producing the same Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): None | Aug 18, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 19, 2018 | Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod Approved Labeled Indication: The treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 19, 2018 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: The treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant (ASCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not ASCT candidates |
| Exclusivity Type: Orphan Drug Exclusivity | Aug 17, 2022 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. Exclusivity Protected Indication: Treatment of patients with classical Hodgkin lymphoma at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation (auto-HSCT) consolidation. |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 9, 2024 | Orphan Designation: Treatment of mycosis fungoides Approved Labeled Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy Exclusivity Protected Indication: Treatment for adult patients with CD30-expressing mycosis fungoides who have received prior systemic therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 9, 2024 | Orphan Designation: Treatment of primary cutaneous CD30-positive T-cell lymphoproliferative disorders Approved Labeled Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy Exclusivity Protected Indication: For adult patients with primary cutaneous anaplastic large cell lymphoma who have received prior systemic therapy |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 20, 2025 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy. Exclusivity Protected Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with chemotherapy. |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 16, 2025 | Orphan Designation: Treatment of peripheral T-cell lymphoma, including anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, angioimmunoblastic T-cell lymphoma, adult T-cell leukemia/lymphoma, enteropathy-associated T-cell lymphoma, and extranod Approved Labeled Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone Exclusivity Protected Indication: ADCETRIS is indicated for the treatment of adult patients with previously untreated sALCL or other CD30-expressing PTCL, including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone |
| Exclusivity Type: Orphan Drug Exclusivity | Nov 10, 2029 | Orphan Designation: Treatment of Hodgkin's lymphoma Approved Labeled Indication: treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL) in combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide Exclusivity Protected Indication: treatment of pediatric patients 2 years and older with previously untreated high risk classical Hodgkin lymphoma (cHL) |
Seres Therapeutics, Inc.
Vowst (Capsule) (Oral) Fecal Microbiota Spores
NDA Applicant: Seres Therapeutics, Inc. BLA No.: 125757 Prod. No.: 001 Rx (1X10 LOG 6 AND 3X10 LOG 7CFU/TAB)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Apr 26, 2030 | Orphan Designation: Treatment of recurrent Clostridium difficile infection (CDI) Approved Labeled Indication: to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI) Exclusivity Protected Indication: to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI) |
| Exclusivity Type: Ref. Product Exclusivity | Apr 26, 2035 |
Servier Pharmaceuticals LLC
Asparlas (Injection) (Intravenous) calaspargase pegol-mknl
NDA Applicant: Servier Pharmaceuticals LLC BLA No.: 761102 Prod. No.: 001 Rx (3,750UNITS/5ML (750UNITS/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. |
Servier Pharmaceuticals LLC
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. |
Solstice NeuroSciences, LLC
Myobloc (Injection) (Intramuscular, Intraglandular) rimabotulinumtoxinB
NDA Applicant: Solstice NeuroSciences, LLC BLA No.: 103846 Prod. No.: 001 Rx (2,500UNITS/0.5ML); 002 Rx (5,000UNITS/ML); 003 Rx (10,000UNITS/2ML (5,000UNITS/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 8, 2007 | Orphan Designation: Treatment of cervical dystonia. Approved Labeled Indication: Treatment of patients with cervical dystonia to reduce the severity of abnormal head position and neck pain associated with cervical dystonia. |
Spark Therapeutics, Inc.
Luxturna (Injection) (Intraocular) Voretigene Neparvovec
NDA Applicant: Spark Therapeutics, Inc. BLA No.: 125610 Prod. No.: 001 Rx (1.5X10 TO 11 ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 19, 2024 | Orphan Designation: Treatment of inherited retinal dystrophy due to biallelic RPE65 gene mutations Approved Labeled Indication: an adeno-associated virus vector-based gene therapy indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy. Patients must have viable retinal cells determined by a treating physician Exclusivity Protected Indication: Treatment of patients with confirmed biallelic RPE65 mutation-associated retinal distrophy. Patients must have viable retinal cells determined by a treating physician. |
Stemline Therapeutics, Inc.
Elzonris (Injection) (Intravenous) tagraxofusp-erzs
NDA Applicant: Stemline Therapeutics, Inc. BLA No.: 761116 Prod. No.: 001 Rx (1,000MCG/1ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 21, 2025 | Orphan Designation: Treatment of blastic plasmacytoid dendritic cell neoplasm Approved Labeled Indication: ELZONRIS is a CD123-directed cytotoxin for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. Exclusivity Protected Indication: ELZONRIS is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older. |
Stratatech Corporation
StrataGraft (Cell Sheets) (Topical) Allogeneic cultured keratinocytes and dermal fibroblasts in murine collagen-dsat
NDA Applicant: Stratatech Corporation BLA No.: 125730 Prod. No.: 001 Rx (100CM SQUARED)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Jun 15, 2028 | Orphan Designation: Treatment of hospitalized patients with complex skin defects resulting from partial and full thickness skin burns requiring excision and grafting Approved Labeled Indication: Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns) Exclusivity Protected Indication: Treatment of adults with thermal burns containing intact dermal elements for which surgical intervention is clinically indicated (deep partial-thickness burns) |
| Exclusivity Type: Ref. Product Exclusivity | Jun 15, 2033 |
Swedish Orphan Biovitrum AB (publ)
Gamifant (Injection) (Intravenous) emapalumab-lzsg
NDA Applicant: Swedish Orphan Biovitrum AB (publ) BLA No.: 761107 Prod. No.: 001 Rx (10MG/2ML (5MG/ML)); 002 Rx (50MG/10ML (5MG/ML)); 003 Rx (100MG/20ML (5MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 20, 2025 | Orphan Designation: Treatment of hemophagocytic lymphohistiocytosis Approved Labeled Indication: GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. Exclusivity Protected Indication: GAMIFANT is indicated for the treatment of adult and pediatric (newborn and older) patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. |
Swedish Orphan Biovitrum AB (publ)
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) |