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Generated: November 13, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209637

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NDA 209637 describes OZEMPIC, which is a drug marketed by Novo Nordisk Inc 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 OZEMPIC profile page.

The generic ingredient in OZEMPIC is semaglutide. One supplier is listed for this compound. Additional details are available on the semaglutide profile page.
Summary for 209637
Tradename:OZEMPIC
Applicant:Novo Nordisk Inc
Ingredient:semaglutide
Patents:18
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 209637
Generic Entry Date for 209637*:
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: 209637
Suppliers and Packaging for NDA: 209637
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637 NDA Novo Nordisk 0169-4132 0169-4132-12 1 SYRINGE, PLASTIC in 1 CARTON (0169-4132-12) > 1.5 mL in 1 SYRINGE, PLASTIC (0169-4132-11)
OZEMPIC semaglutide SOLUTION;SUBCUTANEOUS 209637 NDA Novo Nordisk 0169-4132 0169-4132-97 1 SYRINGE, PLASTIC in 1 CARTON (0169-4132-97) > 1.5 mL in 1 SYRINGE, PLASTIC (0169-4132-90)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength2MG/1.5ML (1.34MG/ML)
Approval Date:Dec 5, 2017TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 5, 2022
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:➤ Try a Free TrialPatent Expiration:Jan 2, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Try a Free TrialPatent Expiration:May 23, 2024Product Flag?YSubstance Flag?Delist Request?

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