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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203202

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NDA 203202 describes NORTHERA, which is a drug marketed by Lundbeck Na Ltd and is included in one NDA. It is available from one supplier. Additional details are available on the NORTHERA profile page.

The generic ingredient in NORTHERA is droxidopa. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the droxidopa profile page.
Summary for 203202
Tradename:NORTHERA
Applicant:Lundbeck Na Ltd
Ingredient:droxidopa
Patents:0
Generic Entry Opportunity Date for 203202
Generic Entry Date for 203202*:
Constraining patent/regulatory exclusivity:
TREATMENT OF NEUROGENIC SYMPTOMATIC ORTHOSTATIC HYPOTENSION IN PATIENTS WITH PRIMARY AUTONOMIC FAILURE, DOPAMINE-BETA-HYDROXYLASE DEFICIENCY, AND NONDIABETIC AUTONOMIC NEUROPATHY
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 203202
Ingredient-typeCatecholamines
Physiological EffectIncreased Blood Pressure
Medical Subject Heading (MeSH) Categories for 203202
Suppliers and Packaging for NDA: 203202
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NORTHERA droxidopa CAPSULE;ORAL 203202 NDA Lundbeck Pharmaceuticals LLC 67386-820 67386-820-19 90 CAPSULE in 1 BOTTLE (67386-820-19)
NORTHERA droxidopa CAPSULE;ORAL 203202 NDA Lundbeck Pharmaceuticals LLC 67386-821 67386-821-19 90 CAPSULE in 1 BOTTLE (67386-821-19)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength100MG
Approval Date:Feb 18, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 18, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Feb 18, 2021
Regulatory Exclusivity Use:TREATMENT OF NEUROGENIC SYMPTOMATIC ORTHOSTATIC HYPOTENSION IN PATIENTS WITH PRIMARY AUTONOMIC FAILURE, DOPAMINE-BETA-HYDROXYLASE DEFICIENCY, AND NONDIABETIC AUTONOMIC NEUROPATHY

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Feb 18, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Feb 18, 2019
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY

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