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 |
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Exclusivity Type: Ref. Product Exclusivity | Jan 14, 2017 |
Mepsevii (Injection) (Intravenous) vestronidase alfa-vjbk
NDA Applicant: Ultragenyx Pharamceutical Inc. BLA No.: 761047 Prod. No.: 001 Rx (10MG/5ML (2MG/ML))
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Nov 15, 2024 | Orphan Designation: Treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome) Approved Labeled Indication: Indicated in pediatric and adult patients for the treatment of Mucopolysaccharidosis VII (PMS VII, Sly syndrome). Exclusivity Protected Indication: Indicated in pediatric and adult patients for the treatment of mucopolysaccharidosis VII (MPS VII, Sly Syndrome). |
Monjuvi (For Injection) (Intravenous) tafasitamab-cxix
NDA Applicant: MorphoSys US Inc. BLA No.: 761163 Prod. No.: 001 Rx (200MG)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Jul 31, 2027 | Orphan Designation: Treatment of diffuse large B-cell lymphoma Approved Labeled Indication: MONJUVI is indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT) Exclusivity Protected Indication: indicated in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT) |
Mononine (For Injection) (Intravenous) Coagulation Factor IX (Human)
NDA Applicant: CSL Behring LLC BLA No.: 103957 Prod. No.: 001 Disc (1000IU); 002 Disc (500IU)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Aug 20, 1999 | Orphan Designation: Replacement treatment and prophylaxis of the hemorrhagic complications of hemophilia B. Approved Labeled Indication: Prevention and control of bleeding in factor IX deficiency, also known as hemophilia B or Christmas disease. |
Myalept (For Injection) (Subcutaneous) metreleptin
NDA Applicant: Amryt Pharmaceuticals DAC BLA No.: 125390 Prod. No.: 001 Rx (11.3MG)
Patents | Expiration | Patented Use |
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Pat. No. 11555176 Cell culture medium for eukaryotic cells Claim Types: Process Pat. Sub. Date(s): None | Jan 27, 2040 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Type: Orphan Drug Exclusivity | Feb 24, 2021 | Orphan Designation: Treatment of metabolic disorders secondary to lipodystrophy Approved Labeled Indication: Adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. Exclusivity Protected Indication: Adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. |
Mylotarg (For Injection) (Intravenous) gemtuzumab ozogamicin
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 761060 Prod. No.: 001 Rx (4.5MG)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | May 17, 2007 | Orphan Designation: Treatment of acute myeloid leukemia Approved Labeled Indication: Treatment of patients with CD33 positive acute myeloid leukemia in first relapse who are 60 years of age or older and who are not considered candidates for cytotoxic chemotherapy |
Exclusivity Type: Orphan Drug Exclusivity | Sep 1, 2024 | Orphan Designation: Treatment of acute myeloid leukemia Approved Labeled Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older Exclusivity Protected Indication: Treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older |
Exclusivity Type: Orphan Drug Exclusivity | Jun 16, 2027 | Orphan Designation: Treatment of acute myeloid leukemia Approved Labeled Indication: Mylotarg is indicated for the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in adults and pediatric patients 1 month and older and treatment of relapsed or refractory CD33-positive acute myeloid leukemia in adults and in pediatric patients 2 years and older. Exclusivity Protected Indication: For the treatment of newly-diagnosed CD33-positive acute myeloid leukemia in pediatric patients 1 month and older |
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 |
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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. |
Myozyme (For Injection) (Intravenous) alglucosidase alfa
NDA Applicant: Genzyme Corporation BLA No.: 125141 Prod. No.: 001 Disc (50MG)
Exclusivity | Expiration | Exclusivity Description |
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Exclusivity Type: Orphan Drug Exclusivity | Apr 28, 2013 | 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. |