Tradenames starting with "L"

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


Lartruvo (Injection) (Intravenous) olaratumab
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate
NDA Applicant: Eli Lilly and Company      BLA No.: 761038  Prod. No.: 001 Disc (500MG/50ML (10MG/ML)); 002 Disc (190MG/19ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityFeb 25, 2020Orphan 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
Drug Classes: Immunological Agents:Immunostimulants == leukocyte growth factor
NDA Applicant: Partner Therapeutics, Inc.      BLA No.: 103362  Prod. No.: 001 Rx (250MCG) BLA No.: 103362  Prod. No.: 002 Disc (500MCG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMar 5, 1998Orphan 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 ExclusivitySep 15, 2002Orphan 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 ExclusivityMar 29, 2025Orphan 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
Drug Classes: Ophthalmic Agents:Ophthalmic Agents, Other
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))
PatentsExpirationPatented Use
Pat. No. 6716602 Metabolic rate shifts in fermentations expressing recombinant proteins
Claim Types: Process
Pat. Sub. Date(s): None
Oct 31, 2021 
Pat. No. 6828121 Bacterial host strains
Claim Types: Bacterial strain; Process
Pat. Sub. Date(s): None
Jul 7, 2022 
Pat. No. 6921659 Protease-deficient cells
Claim Types: Bacterial strain; Process
Pat. Sub. Date(s): None
Oct 16, 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 7, 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 9, 2034 
Pat. No. 10017732 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 2034 
Pat. No. 10112994 Methods of producing two chain proteins in bacteria
Claim Types: Process
Pat. Sub. Date(s): None
Nov 4, 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 18, 2033 
Pat. No. 10829732 Cell culture compositions with antioxidants and methods for polypeptide production
Claim Types: Process
Pat. Sub. Date(s): None
Mar 13, 2034 

Lumoxiti (For Injection) (Intravenous) moxetumomab pasudotox-tdfk
Drug Classes: Antineoplastics:Monoclonal Antibody/Antibody-Drug Conjugate
NDA Applicant: Innate Pharma, Inc.      BLA No.: 761104  Prod. No.: 001 Rx (1MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivitySep 13, 2025Orphan 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).

Luxturna (Injection) (Intraocular) Voretigene Neparvovec
Drug Classes: adeno-associated virus vector-based gene therapy
NDA Applicant: Spark Therapeutics, Inc.      BLA No.: 125610  Prod. No.: 001 Rx (1.5X10 TO 11 ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 19, 2024Orphan 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.



Last edited: 15 November 2022
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