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Generated: April 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203314

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NDA 203314 describes TRESIBA, which is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are sixteen patents protecting this drug. Additional details are available on the TRESIBA profile page.

The generic ingredient in TRESIBA is insulin degludec. There are forty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the insulin degludec profile page.
Summary for 203314
Ingredient:insulin degludec
Generic Entry Opportunity Date for 203314
Generic Entry Date for 203314*:
Constraining patent/regulatory exclusivity:

*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: 203314
Suppliers and Packaging for NDA: 203314
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314 NDA Novo Nordisk 0169-2550 0169-2550-13 3 SYRINGE, PLASTIC in 1 CARTON (0169-2550-13) > 3 mL in 1 SYRINGE, PLASTIC
TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314 NDA Novo Nordisk 0169-2550 0169-2550-97 1 SYRINGE, PLASTIC in 1 CARTON (0169-2550-97) > 3 mL in 1 SYRINGE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength300 UNITS/3ML (100 UNITS/ML)
Approval Date:Sep 25, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 25, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 16, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:➤ Sign UpPatent Expiration:Jan 2, 2022Product Flag?YSubstance Flag?Delist Request?

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