Tradenames starting with "N"

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


Naglazyme (Injection) (Intravenous) galsulfase
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment == hydrolytic lysozomal glycosaminoglycan (GAG)-specific enzyme
NDA Applicant: BioMarin Pharmaceutical Inc.      BLA No.: 125117  Prod. No.: 001 Rx (5MG/5ML (1MG/ML))
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityMay 31, 2012Orphan 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.

Natpara (For Injection) (Subcutaneous) parathyroid hormone
Drug Classes: Metabolic Bone Disease Agents == parathyroid hormone
NDA Applicant: NPS Pharmaceuticals, Inc.      BLA No.: 125511  Prod. No.: 001 Rx (25MCG); 002 Rx (50MCG); 003 Rx (75MCG); 004 Rx (100MCG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJan 23, 2022Orphan Designation: Treatment of hypoparathyroidism
Approved Labeled Indication: An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism
Exclusivity Protected Indication: An adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism

Neulasta; Neulasta Onpro (Injection) (Subcutaneous) pegfilgrastim
Drug Classes: leukocyte growth factor
NDA Applicant: Amgen, Inc.      BLA No.: 125031  Prod. No.: 001 Rx (6MG/0.6ML); 002 Rx (6MG/0.6ML)
PatentsExpirationPatented Use
Pat. No. 9856287 Refolding proteins using a chemically controlled redox state
Claim Types: Process
Pat. Sub. Date(s): None
Jun 21, 2030 
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 13, 2022Orphan Designation: Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident
Approved Labeled Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome)
Exclusivity Protected Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome)

Neumega (For Injection) (Subcutaneous) oprelvekin
Drug Classes: megakaryocyte growth factor
NDA Applicant: Wyeth Pharmaceuticals Inc.      BLA No.: 103694  Prod. No.: 001 Disc (5MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityNov 25, 2004Orphan Designation: Prevention of severe chemotherapy-induced thrombocytopenia.

Neupogen (Injection) (Intravenous, Subcutaneous ) filgrastim
Drug Classes: Immunological Agents:Immunostimulants == leukocyte growth factor
NDA Applicant: Amgen, Inc.      BLA No.: 103353  Prod. No.: 001 Rx (300MCG/ML); 002 Rx (480MCG/1.6ML); 003 Rx (300MCG/0.5ML); 004 Rx (480MCG/0.8ML)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 15, 2001Orphan Designation: Treatment of neutropenia associated with bone marrow transplants.
Approved Labeled Indication: Reduce the duration of neutropenia and neutropenia sequelae in patients with non-myeloid malignancies undergoing ablative chemotherapy followed by BMT.
Exclusivity Type: Orphan Drug ExclusivityDec 19, 2001Orphan Designation: Treatment of patients with severe chronic neutropenia (absolute neutrophil count less than 500/mm3).
Approved Labeled Indication: Treatment of patients with severe chronic neutropenia.
Exclusivity Type: Orphan Drug ExclusivityDec 28, 2002Orphan Designation: For use in the mobilization of peripheral blood progenitor cells for collection in patients who will receive myeloablative or myelosuppressive chemotherapy.
Approved Labeled Indication: For use in the mobilization of hematopoietic progenitor cells into the peripheral blood collection by leukapheresis.
Exclusivity Type: Orphan Drug ExclusivityApr 2, 2005Orphan Designation: Reduction in the duration of neutropenia, fever, antibiotic use, and hospitalization, following induction and consolidation treatment for acute myeloid leukemia.
Approved Labeled Indication: Reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia.
Exclusivity Type: Orphan Drug ExclusivityMar 30, 2022Orphan Designation: Treatment of subjects at risk of developing myelosuppression after a radiological or nuclear incident
Approved Labeled Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).
Exclusivity Protected Indication: To increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome).

Norditropin (Injection) (Subcutaneous) somatropin
Drug Classes: Gastrointestinal Agents:Gastrointestinal Agents, Other == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary) == recombinant human growth hormone
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

Novoseven, Novoseven Rt (For Injection) (Intravenous) Coagulation Factor VIIa (Recombinant)
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == human blood coagulation factor ==
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.

Nplate (For Injection) (Subcutaneous) romiplostim
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other
NDA Applicant: Amgen, Inc.      BLA No.: 125268  Prod. No.: 001 Rx (250MCG); 002 Rx (500MCG); 003 Rx (125MCG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityAug 22, 2015Orphan Designation: Treatment of immune thrombocytopenic purpura
Approved Labeled Indication: Treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
Exclusivity Type: Orphan Drug ExclusivityDec 14, 2025Orphan Designation: Treatment of immune thrombocytopenic purpura
Approved Labeled Indication: Nplate is indicated for the treatment of thrombocytopenia in pediatric patients 1 year of age and older with ITP for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Exclusivity Protected Indication: Nplate is indicated for the treatment of pediatric patients 1 year of age and older with immune thrombocytopenia (ITP) for at least 6 months who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Exclusivity Type: Orphan Drug ExclusivityOct 17, 2026Orphan Designation: Treatment of immune thrombocytopenic purpura
Approved Labeled Indication: Nplate is indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy
Exclusivity Protected Indication: For the treatment of thrombocytopenia in adult patients with non-chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
Exclusivity Type: Orphan Drug ExclusivityJan 28, 2028Orphan Designation: Treatment of patients acutely exposed to myelosuppressive doses of radiation following radiological/nuclear incident
Approved Labeled Indication: to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS])
Exclusivity Protected Indication: to increase survival in adults and pediatric patients (including term neonates) acutely exposed to myelosuppressive doses of radiation (Hematopoietic Syndrome of Acute Radiation Syndrome [HS-ARS])

Nucala (For Injection) (Subcutaneous) mepolizumab
Drug Classes: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == interleukin-5 antagonist
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 12, 2024Orphan 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 ExclusivitySep 25, 2027Orphan 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

Nucala (For Injection) (Subcutaneous) mepolizumab
Drug Classes: Respiratory Tract/ Pulmonary Agents:Respiratory Tract Agents, Other == interleukin-5 antagonist
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)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityDec 12, 2024Orphan 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 ExclusivitySep 25, 2027Orphan 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

Nulojix (For Injection) (Intravenous) belatacept
Drug Classes: Immunological Agents:Immunological Agents, Other == selective T-cell costimulation blocker
NDA Applicant: Bristol-Myers Squibb Company      BLA No.: 125288  Prod. No.: 001 Rx (250MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityJun 15, 2018Orphan Designation: Prophylaxis of organ rejection in renal allograft recipients
Approved Labeled Indication: Prophylaxis of organ rejection in adult patients receiving kidney transplants

Nutropin (For Injection) (Subcutaneous) somatropin
Drug Classes: Gastrointestinal Agents:Gastrointestinal Agents, Other == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary) == recombinant human growth hormone
NDA Applicant: Genentech, Inc.      BLA No.: 020168  Prod. No.: 001 Disc (5MG); 002 Disc (10MG)
ExclusivityExpirationExclusivity Description
Exclusivity Type: Orphan Drug ExclusivityOct 17, 1992Orphan Designation: For use in the long-term treatment of children who have growth failure due to a lack of adequate endogenous growth hormone secretion.
Exclusivity Type: Orphan Drug ExclusivityNov 17, 2000Orphan Designation: Treatment of growth retardation associated with chronic renal failure.
Approved Labeled Indication: Treatment of children with growth failure associated with chronic renal insufficency.
Exclusivity Type: Orphan Drug ExclusivityDec 30, 2003Orphan Designation: Treatment of short stature associated with Turner's syndrome.
Approved Labeled Indication: Treatment of growth failure associated with Turner syndrome.
Exclusivity Type: Orphan Drug ExclusivityDec 15, 2004Orphan Designation: As replacement therapy for growth hormone deficiency in adults after epiphyseal closure.



Last edited: 15 November 2022
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