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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 215256


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NDA 215256 describes WEGOVY, which is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are seven patents protecting this drug. Additional details are available on the WEGOVY profile page.

The generic ingredient in WEGOVY is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.
Summary for 215256
Tradename:WEGOVY
Applicant:Novo
Ingredient:semaglutide
Patents:7
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215256
Generic Entry Date for 215256*:
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: 215256
Suppliers and Packaging for NDA: 215256
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256 NDA Novo Nordisk 0169-4501 0169-4501-14 4 SYRINGE, PLASTIC in 1 CARTON (0169-4501-14) / .5 mL in 1 SYRINGE, PLASTIC (0169-4501-01)
WEGOVY semaglutide SOLUTION;SUBCUTANEOUS 215256 NDA Novo Nordisk 0169-4505 0169-4505-14 4 SYRINGE, PLASTIC in 1 CARTON (0169-4505-14) / .5 mL in 1 SYRINGE, PLASTIC (0169-4505-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength0.25MG/0.5ML (0.25MG/0.5ML)
Approval Date:Jun 4, 2021TE:RLD:Yes
Regulatory Exclusivity Expiration:Mar 8, 2027
Regulatory Exclusivity Use:IN COMBINATION WITH A REDUCED CALORIE DIET AND INCREASED PHYSICAL ACTIVITY TO REDUCE THE RISK OF MAJOR ADVERSE CARDIOVASCULAR EVENTS (CARDIOVASCULAR DEATH, NON-FATAL MYOCARDIAL INFARCTION, OR NON-FATAL STROKE) IN ADULTS WITH ESTABLISHED CARDIOVASCULAR DISEASE AND EITHER OBESITY OR OVERWEIGHT
Regulatory Exclusivity Expiration:Dec 23, 2025
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jun 4, 2024
Regulatory Exclusivity Use:NEW PRODUCT

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