Details for New Drug Application (NDA): 215256
✉ Email this page to a colleague
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
Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
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: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 0.25MG/0.5ML (0.25MG/0.5ML) | ||||
Approval Date: | Jun 4, 2021 | TE: | 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 |
Complete Access Available with Subscription