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 nine 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.
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: | 9 |
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: | Aug 15, 2028 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF NONCIRRHOTIC METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH), FORMERLYKNOWN AS NONALCOHOLIC STEATOHEPATITIS (NASH), WITH MODERATE TO ADVANCED LIVER FIBROSIS (CONSISTENT WITH STAGES F2 TO F3 FIBROSIS) IN ADULTS | ||||||||
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