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 | Feb 16, 2030 | Orphan Designation: Treatment of alpha-mannosidosis Approved Labeled Indication: treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients Exclusivity Protected Indication: treatment of non-central nervous system manifestations of alpha-mannosidosis in adult and pediatric patients |
Lartruvo (Injection) (Intravenous) olaratumab
NDA Applicant: Eli Lilly and Company BLA No.: 761038 Prod. No.: 001 Disc (500MG/50ML (10MG/ML)); 002 Disc (190MG/19ML (10MG/ML))
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Feb 25, 2020 | 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. |
Leukine (For Injection) (Intravenous, Subcutaneous ) sargramostim
NDA Applicant: Partner Therapeutics, Inc. BLA No.: 103362 Prod. No.: 001 Rx (250MCG) BLA No.: 103362 Prod. No.: 002 Disc (500MCG/ML)
| Exclusivity | Expiration | Exclusivity Description |
|---|---|---|
| Exclusivity Type: Orphan Drug Exclusivity | Mar 5, 1998 | Orphan Designation: Treatment of neutropenia associated with bone marrow transplant, for the treatment of graft failure and delay of engraftment, and for the promotion of early engraftment. |
| Exclusivity Type: Orphan Drug Exclusivity | Sep 15, 2002 | Orphan Designation: To reduce neutropenia and leukopenia and decrease the incidence of death due to infection in patients with acute myelogenous leukemia. Approved Labeled Indication: Following induction chemotherapy in older adult patients with acute myelogenous leukemia to shorten time to neutrophil recovery and to reduce the incidence of severe and life-threatening infections and infections resulting in death. |
| Exclusivity Type: Orphan Drug Exclusivity | Mar 29, 2025 | Orphan Designation: Treatment of individuals acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome) Approved Labeled Indication: LEUKINE is indicated to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]). Exclusivity Protected Indication: to increase survival in adult and pediatric patients from birth to 17 years of age acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [H-ARS]) |
Lucentis (Injection) (Intravitreal) ranibizumab
NDA Applicant: Genentech, Inc. BLA No.: 125156 Prod. No.: 001 Rx (10MG/ML (0.5MG/0.05ML)); 002 Rx (6MG/ML (0.3MG/0.05ML)); 003 Rx (10MG/ML (0.5MG/0.05ML)); 004 Rx (6MG/ML (0.3MG/0.05ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6716602 Metabolic rate shifts in fermentations expressing recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Nov 1, 2021 | |
| Pat. No. 6828121 Bacterial host strains Claim Types: Bacterial strain; Process Pat. Sub. Date(s): None | Jul 8, 2022 | |
| Pat. No. 6921659 Protease-deficient cells Claim Types: Bacterial strain; Process Pat. Sub. Date(s): None | Oct 17, 2023 | |
| Pat. No. 8383773 Protein product and method for reducing biomass-biomass interactions Claim Types: Product-by-process Pat. Sub. Date(s): None | Dec 13, 2023 | |
| Pat. No. 8574869 Prevention of disulfide bond reduction during recombinant production of polypeptides Claim Types: Process Pat. Sub. Date(s): None | Jul 8, 2028 | |
| Pat. No. 9688775 System for antibody expression and assembly Claim Types: Process Pat. Sub. Date(s): None | Dec 31, 2022 | |
| Pat. No. 9765379 Harvest operations for recombinant proteins Claim Types: Process Pat. Sub. Date(s): None | Mar 10, 2034 | |
| Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 | |
| Pat. No. 10112994 Methods of producing two chain proteins in bacteria Claim Types: Process Pat. Sub. Date(s): None | Nov 5, 2035 | |
| Pat. No. 10421984 Methods for reducing norleucine misincorporation into proteins using a microorganism comprising a mutant metA allele Claim Types: Process Pat. Sub. Date(s): None | Sep 19, 2033 | |
| Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production Claim Types: Process Pat. Sub. Date(s): None | Mar 14, 2034 |
Lumoxiti (For Injection) (Intravenous) moxetumomab pasudotox-tdfk
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). |
Lunsumio (Injection) (Intravenous) mosunetuzumab-axgb
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 |
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. |