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Last Updated: October 24, 2019

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 and is included in one NDA. It is available from two suppliers. There are twenty-one patents protecting this drug. Additional details are available on the OZEMPIC profile page.

The generic ingredient in OZEMPIC is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.
Summary for 209637
Tradename:OZEMPIC
Applicant:Novo
Ingredient:semaglutide
Patents:21
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:  Start TrialPatent Expiration:Jul 17, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Jun 21, 2033Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING TYPE 2 DIABETES COMPRISING ADMINISTERING SEMAGLUTIDE ONCE WEEKLY IN A AMOUNT OF 1.0 MG TO A SUBJECT IN NEED THEREOF

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