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 six 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: | 6 |
| Formulation / Manufacturing: | see details |
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: | Dec 23, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Jun 4, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 24, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | METHOD FOR WEIGHT MANAGEMENT | ||||||||
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