Company names starting with "N"

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.

Novartis Gene Therapies, Inc.
Zolgensma (Injection) (Intravenous) onasemnogene abeparvovec-xioi
NDA Applicant: Novartis Gene Therapies, Inc.      BLA No.: 125694  Prod. No.: 001 Rx (1.1X10E14 VG/KG VG/KG=VECTOR GENOMES PER KILOGRAM)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 24, 2026Orphan Designation: Treatment of spinal muscular atrophy
Approved Labeled Indication: Indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Exclusivity Protected Indication: Indicated for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene.
Exclusivity Type: Ref. Product ExclusivityMay 24, 2031 

Novartis Pharmaceuticals Corporation
Adakveo (Injection) (Intravenous) crizanlizumab-tmca
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 761128  Prod. No.: 001 Rx (100MG/10ML (10MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 15, 2026Orphan Designation: Treatment of sickle cell disease
Approved Labeled Indication: ADAKVEO is indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.
Exclusivity Protected Indication: Indicated to reduce the frequency of vasoocclusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease.

Novartis Pharmaceuticals Corporation
Arzerra (Injection) (Intravenous) ofatumumab
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 125326  Prod. No.: 001 Disc (100MG/5ML); 002 Disc (1,000MG/50ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 26, 2016Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: Treatment of chronic lymphocytic leukemia (CLL) refractory to alemtuzumab and fludarabine
Exclusivity Type: Orphan Drug ExclusivityApr 17, 2021Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: ARZERRA (ofatumumab) is indicated, in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Exclusivity Protected Indication: Ofatumumab in combination with chlorambucil, for the treatment of previously untreated patients with chronic lymphocytic leukemia (CLL) for whom fludarabine-based therapy is considered inappropriate.
Exclusivity Type: Orphan Drug ExclusivityJan 19, 2023Orphan Designation: Treatment of chronic lymphocytic leukemia
Approved Labeled Indication: For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.
Exclusivity Protected Indication: For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL.

Novartis Pharmaceuticals Corporation
Ilaris (For Injection) (Subcutaneous) canakinumab
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 125319  Prod. No.: 001 Rx (150MG); 002 Rx (150MG/ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 17, 2016Orphan Designation: Treatment of cryopyrin-associated periodic syndromes
Approved Labeled Indication: Treatment of cryopyrin-associated periodic syndromes (CAPS), in adults and children 4 years of age and older.
Exclusivity Type: Orphan Drug ExclusivityMay 9, 2020Orphan Designation: Treatment of pediatric (age 16 and under) juvenile rheumatoid arthritis.
Approved Labeled Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
Exclusivity Protected Indication: Treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 through 16 years.
Exclusivity Type: Orphan Drug ExclusivitySep 23, 2023Orphan Designation: Treatment of familial mediterranean fever
Approved Labeled Indication: Indicated for treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients
Exclusivity Protected Indication: Indicated for treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients
Exclusivity Type: Orphan Drug ExclusivitySep 23, 2023Orphan Designation: Treatment of TNF-receptor associated periodic syndrome (TRAPS)
Approved Labeled Indication: Indicated for the treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients
Exclusivity Protected Indication: Indicated for treatment of Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients
Exclusivity Type: Orphan Drug ExclusivitySep 23, 2023Orphan Designation: Treatment of hyperimmunoglobulinemia D and periodic fever syndrome
Approved Labeled Indication: Indicated for Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients
Exclusivity Protected Indication: Indicated for Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients
Exclusivity Type: Orphan Drug ExclusivityJun 16, 2027Orphan Designation: Treatment of adult-onset Still's Disease
Approved Labeled Indication: ILARIS is indicated for the treatment of active Stills disease, including Adult-Onset Stills Disease (AOSD) and Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
Exclusivity Protected Indication: For the treatment of active adult-onset Stills Disease (AOSD).

Novartis Pharmaceuticals Corporation
Kymriah (Injection) (Intravenous) tisagenlecleucel
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 125646  Prod. No.: 001 Rx (0.6 to 6.0 x 10^8 CAR-POSITIVE VIABLE T CELLS)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 1, 2025Orphan Designation: Treatment of diffuse large B-cell lymphoma
Approved Labeled Indication: KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of Adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma
Exclusivity Protected Indication: For treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma after two or more lines of systemic therapy.
Exclusivity Type: Orphan Drug ExclusivityMay 27, 2029Orphan Designation: Treatment of follicular lymphoma
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy
Exclusivity Protected Indication: Treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy

Novartis Pharmaceuticals Corporation
Simulect (For Injection) (Intravenous) basiliximab
NDA Applicant: Novartis Pharmaceuticals Corporation      BLA No.: 103764  Prod. No.: 001 Rx (20MG); 002 Rx (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 12, 2005Orphan Designation: Prophylaxis of solid organ rejection.
Approved Labeled Indication: Prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.

Novo Nordisk Inc.
Norditropin (Injection) (Subcutaneous) somatropin
NDA Applicant: Novo Nordisk Inc.      BLA No.: 021148  Prod. No.: 008 Rx (5MG/1.5ML); 009 Rx (10MG/1.5ML); 010 Rx (15MG/1.5ML); 011 Rx (30MG/3ML) BLA No.: 021148  Prod. No.: 001 Disc (5MG/1.5ML); 002 Disc (10MG/1.5ML); 003 Disc (15MG/1.5ML); 004 Disc (5MG/1.5ML); 005 Disc (10MG/1.5ML); 006 Disc (15MG/1.5ML); 007 Disc (30MG/3ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 31, 2014Orphan Designation: Treatment of short stature in patients with Noonan syndrome
Approved Labeled Indication: Treatment of short stature in patients with Noonan syndrome

Novo Nordisk Inc.
Novoseven, Novoseven Rt (For Injection) (Intravenous) Coagulation Factor VIIa (Recombinant)
NDA Applicant: Novo Nordisk Inc.      BLA No.: 103665  Prod. No.: 004 Rx (5.0MG); 005 Rx (1.0MG); 006 Rx (2.0MG); 007 Rx (8.0MG) BLA No.: 103665  Prod. No.: 001 Disc (2.4MG); 002 Disc (1.2MG); 003 Disc (4.8MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJul 2, 2021Orphan 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.

Novo Nordisk Inc.
Tretten (For Injection) (Intravenous) Coagulation Factor XIII A-Subunit (Recombinant)
NDA Applicant: Novo Nordisk Inc.      BLA No.: 125398  Prod. No.: 001 Rx (2000 - 3125IU)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 23, 2020Orphan Designation: Prophylaxis of bleeding associated with congential factor XIII deficiency
Approved Labeled Indication: Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.
Exclusivity Protected Indication: Routine prophylaxis of bleeding in patients with congenital Factor XIII A-subunit deficiency.


Last edited: 19 August 2023
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