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.

N/A (Injection) (Intravenous) raxibacumab
NDA Applicant: Emergent Manufacturing Operations Baltimore LLC BLA No.: 125349 Prod. No.: 001 Rx (1,700MG/34ML (50MG/ML))

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 14, 2019	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.

N/A (Injection) (Intravenous) HPC, Cord Blood
NDA Applicant: Clinimmune Labs BLA No.: 125391 Prod. No.: 001 Rx (5X10^8 TOTAL NUCLEATED CELLS WITH AT LEAST 1.25X10^6 VIABLE CD34+ CELLS)

Patents Expiration Patented Use

Pat. No. 11559564 Use of a VEGF antagonist to treat angiogenic eye disorders
Claim Types: Method of use; Dosaage regimen
Pat. Sub. Date(s): None Jan 11, 2032
Pat. No. 11577025 Devices and methods for overfilling drug containers
Claim Types: Process
Pat. Sub. Date(s): None Oct 6, 2037

Patents	Expiration	Patented Use
Pat. No. 11559564 Use of a VEGF antagonist to treat angiogenic eye disorders Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): None	Jan 11, 2032
Pat. No. 11577025 Devices and methods for overfilling drug containers Claim Types: Process Pat. Sub. Date(s): None	Oct 6, 2037

Naglazyme (Injection) (Intravenous) galsulfase
NDA Applicant: BioMarin Pharmaceutical Inc. BLA No.: 125117 Prod. No.: 001 Rx (5MG/5ML (1MG/ML))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity May 31, 2012 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	May 31, 2012	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.

Natpara (For Injection) (Subcutaneous) parathyroid hormone
NDA Applicant: Takeda Pharmaceuticals U.S.A., Inc. BLA No.: 125511 Prod. No.: 001 Rx (25MCG); 002 Rx (50MCG); 003 Rx (75MCG); 004 Rx (100MCG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jan 23, 2022 Orphan 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

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jan 23, 2022	Orphan 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
NDA Applicant: Amgen Inc. BLA No.: 125031 Prod. No.: 001 Rx (6MG/0.6ML); 002 Rx (6MG/0.6ML)

Patents Expiration Patented Use

Pat. No. 9856287 Refolding proteins using a chemically controlled redox state
Claim Types: Process
Pat. Sub. Date(s): None Jun 21, 2030
Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Nov 13, 2022 Orphan 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)

Patents	Expiration	Patented Use
Pat. No. 9856287 Refolding proteins using a chemically controlled redox state Claim Types: Process Pat. Sub. Date(s): None	Jun 21, 2030
Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Nov 13, 2022	Orphan 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
NDA Applicant: Wyeth Pharmaceuticals Inc. BLA No.: 103694 Prod. No.: 001 Disc (5MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Nov 25, 2004 Orphan Designation: Prevention of severe chemotherapy-induced thrombocytopenia.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Nov 25, 2004	Orphan Designation: Prevention of severe chemotherapy-induced thrombocytopenia.

Neupogen (Injection) (Intravenous, Subcutaneous ) filgrastim
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)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jun 15, 2001 Orphan 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 Exclusivity Dec 19, 2001 Orphan 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 Exclusivity Dec 28, 2002 Orphan 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 Exclusivity Apr 2, 2005 Orphan 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 Exclusivity Mar 30, 2022 Orphan 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).

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jun 15, 2001	Orphan 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 Exclusivity	Dec 19, 2001	Orphan 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 Exclusivity	Dec 28, 2002	Orphan 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 Exclusivity	Apr 2, 2005	Orphan 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 Exclusivity	Mar 30, 2022	Orphan 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).

Nexobrid (For Topical Gel) (Topical) anacaulase-bcdb
NDA Applicant: MediWound, Ltd. BLA No.: 761192 Prod. No.: 001 Disc (8.8% (1.94GM)); 002 Disc (8.8% (4.85GM))

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Dec 28, 2029 Orphan Designation: Debridement of acute, deep dermal burns in hospitalized patients
Approved Labeled Indication: eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns
Exclusivity Protected Indication: eschar removal in hospitalized adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Dec 28, 2029	Orphan Designation: Debridement of acute, deep dermal burns in hospitalized patients Approved Labeled Indication: eschar removal in adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns Exclusivity Protected Indication: eschar removal in hospitalized adults with deep partial thickness (DPT) and/or full thickness (FT) thermal burns

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)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity May 31, 2014 Orphan Designation: Treatment of short stature in patients with Noonan syndrome
Approved Labeled Indication: Treatment of short stature in patients with Noonan syndrome

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	May 31, 2014	Orphan 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)
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)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jul 2, 2021 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.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jul 2, 2021	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.

Nplate (For Injection) (Subcutaneous) romiplostim
NDA Applicant: Amgen Inc. BLA No.: 125268 Prod. No.: 001 Rx (250MCG); 002 Rx (500MCG); 003 Rx (125MCG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Aug 22, 2015 Orphan 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 Exclusivity Dec 14, 2025 Orphan 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 Exclusivity Oct 17, 2026 Orphan 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 Exclusivity Jan 28, 2028 Orphan 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])

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Aug 22, 2015	Orphan 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 Exclusivity	Dec 14, 2025	Orphan 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 Exclusivity	Oct 17, 2026	Orphan 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 Exclusivity	Jan 28, 2028	Orphan 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
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

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

Nucala (For Injection) (Subcutaneous) mepolizumab
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

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

Nulojix (For Injection) (Intravenous) belatacept
NDA Applicant: Bristol-Myers Squibb Company BLA No.: 125288 Prod. No.: 001 Rx (250MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Jun 15, 2018 Orphan Designation: Prophylaxis of organ rejection in renal allograft recipients
Approved Labeled Indication: Prophylaxis of organ rejection in adult patients receiving kidney transplants

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Jun 15, 2018	Orphan 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
NDA Applicant: Genentech, Inc. BLA No.: 020168 Prod. No.: 001 Disc (5MG); 002 Disc (10MG)

Exclusivity Expiration Exclusivity Description

Exclusivity Type: Orphan Drug Exclusivity Oct 17, 1992 Orphan 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 Exclusivity Nov 17, 2000 Orphan 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 Exclusivity Dec 30, 2003 Orphan 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 Exclusivity Dec 15, 2004 Orphan Designation: As replacement therapy for growth hormone deficiency in adults after epiphyseal closure.

Exclusivity	Expiration	Exclusivity Description
Exclusivity Type: Orphan Drug Exclusivity	Oct 17, 1992	Orphan 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 Exclusivity	Nov 17, 2000	Orphan 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 Exclusivity	Dec 30, 2003	Orphan 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 Exclusivity	Dec 15, 2004	Orphan Designation: As replacement therapy for growth hormone deficiency in adults after epiphyseal closure.