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Generated: May 22, 2019

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Details for New Drug Application (NDA): 208583

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NDA 208583 describes XULTOPHY 100/3.6, which is a drug marketed by Novo and is included in one NDA. It is available from one supplier. There are eighteen patents protecting this drug. Additional details are available on the XULTOPHY 100/3.6 profile page.

The generic ingredient in XULTOPHY 100/3.6 is insulin degludec; liraglutide. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin degludec; liraglutide profile page.
Summary for 208583
Tradename:XULTOPHY 100/3.6
Applicant:Novo
Ingredient:insulin degludec; liraglutide
Patents:18
Generic Entry Opportunity Date for 208583
Generic Entry Date for 208583*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS

*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: 208583
Suppliers and Packaging for NDA: 208583
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583 NDA Novo Nordisk 0169-2911 0169-2911-15 5 SYRINGE, PLASTIC in 1 CARTON (0169-2911-15) > 3 mL in 1 SYRINGE, PLASTIC
XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583 NDA Novo Nordisk 0169-2911 0169-2911-97 1 SYRINGE, PLASTIC in 1 CARTON (0169-2911-97) > 3 mL in 1 SYRINGE, PLASTIC (0169-2911-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength300 UNITS/3ML;10.8MG/3ML (100 UNITS/ML;3.6MG/ML)
Approval Date:Nov 21, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 25, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 21, 2019
Regulatory Exclusivity Use:NEW COMBINATION
Patent:➤ Sign UpPatent Expiration:Aug 22, 2022Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 208583

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 ➤ Sign Up ➤ Sign Up
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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