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: Orphan Drug Exclusivity | Aug 30, 2012 | Orphan Designation: Treatment of growth hormone insensitivity syndrome. Approved Labeled Indication: Long-term treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone. |
mecasermin rinfabate (Injection) (Subcutaneous) Iplex
NDA Applicant: Insmed Incorporated BLA No.: 021884 Prod. No.: 001 Disc (36MG/0.6ML (60MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 12, 2012 | Orphan Designation: Treatment of growth hormone insensitivity syndrome (GHIS) Approved Labeled Indication: Treatment of growth failure in children with severe primary IGF-1 deficiency (Primary IGFD) or with growth hormone (GH) gene deletion who have developed neutralizing antibodies to growth hormone |
Meningococcal (Groups A, C, Y, W) Conjugate Vaccine (Injection) (Intramuscular) Menquadfi
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 |
Meningococcal Group B Vaccine (Injection) (Intramuscular) Trumenba
NDA Applicant: Wyeth Pharmaceuticals LLC BLA No.: 125549 Prod. No.: 001 Rx (0.5ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Ref. Product Exclusivity | Oct 29, 2026 |
mepolizumab (For Injection) (Subcutaneous) Nucala
NDA Applicant: GlaxoSmithKline LLC BLA No.: 125526 Prod. No.: 001 Rx (100MG); 002 Rx (100MG/ML); 003 Rx (100MG/ML); 004 Rx (40MG/0.4ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 12, 2024 | Orphan Designation: Treatment of Churg-Strauss Syndrome Approved Labeled Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA) Exclusivity Protected Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA) |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 25, 2027 | Orphan Designation: For treatment of hypereosinophilic syndrome Approved Labeled Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause Exclusivity Protected Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause |
mepolizumab (For Injection) (Subcutaneous) Nucala
NDA Applicant: GlaxoSmithKline LLC BLA No.: 761122 Prod. No.: 001 Rx (100MG); 002 Rx (100MG/ML); 003 Rx (100MG/ML); 004 Rx (40MG/0.4ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 12, 2024 | Orphan Designation: Treatment of Churg-Strauss Syndrome Approved Labeled Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA) Exclusivity Protected Indication: Treatment of adult patients with Eosinophilic Granulomatosis Polyangiitis (EGPA) |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 25, 2027 | Orphan Designation: For treatment of hypereosinophilic syndrome Approved Labeled Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause Exclusivity Protected Indication: treatment of adult and pediatric patients aged 12 years and older with hypereosinophilic syndrome (HES) for > or = 6 months without an identifiable non-hematologic secondary cause |
metreleptin (For Injection) (Subcutaneous) Myalept
NDA Applicant: Amryt Pharmaceuticals DAC BLA No.: 125390 Prod. No.: 001 Rx (11.3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| 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. |
mirvetuximab soravtansine-gynx (Injection) (Intravenous) Elahere
NDA Applicant: ImmunoGen, Inc. BLA No.: 761310 Prod. No.: 001 Rx (100MG/20ML (5MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Nov 14, 2029 | Orphan Designation: Treatment of ovarian cancer Approved Labeled Indication: treatment of adult patients with folate receptor-alpha (FR?) positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens. Select patients for therapy based on an FDA-approved test. Exclusivity Protected Indication: treatment of adult patients with folate receptor-alpha (FR?) positive, platinum-resistant epithelial ovarian cancer, as detected by an FDA-approved test, who have received one to three prior systemic treatment regimens |
mogamulizumab-kpkc (Injection) (Intravenous) Poteligeo
NDA Applicant: Kyowa Kirin, Inc. BLA No.: 761051 Prod. No.: 001 Rx (20MG/5ML (4MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Aug 8, 2025 | Orphan Designation: Treatment of patients with cutaneous T-cell lymphoma. Approved Labeled Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S_ry syndrome (SS) after at least one prior systemic therapy. Exclusivity Protected Indication: POTELIGEO is indicated for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or S_ry syndrome (SS) after at least one prior systemic therapy. |
mosunetuzumab-axgb (Injection) (Intravenous) Lunsumio
NDA Applicant: Genentech, Inc. BLA No.: 761263 Prod. No.: 001 Rx (1MG/ML); 002 Rx (30MG/30ML (1MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Dec 22, 2029 | Orphan Designation: Treatment of follicular lymphoma Approved Labeled Indication: treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy Exclusivity Protected Indication: treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy |
moxetumomab pasudotox-tdfk (For Injection) (Intravenous) Lumoxiti
NDA Applicant: Innate Pharma, Inc. BLA No.: 761104 Prod. No.: 001 Disc (1MG)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Sep 13, 2025 | Orphan Designation: Treatment of hairy cell leukemia Approved Labeled Indication: LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). Exclusivity Protected Indication: LUMOXITI is indicated for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA). |