Details for New Drug Application (NDA): 218316
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NDA 218316 describes WEGOVY, which is a drug marketed by Novo and is included in two NDAs. It is available from two suppliers. There are eighteen patents protecting this drug. Additional details are available on the WEGOVY profile page.
The generic ingredient in WEGOVY is semaglutide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.
The generic ingredient in WEGOVY is semaglutide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.
Summary for 218316
| Tradename: | WEGOVY |
| Applicant: | Novo |
| Ingredient: | semaglutide |
| Patents: | 9 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 218316
Generic Entry Date for 218316*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL |
*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: 218316
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Suppliers and Packaging for NDA: 218316
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| WEGOVY | semaglutide | TABLET;ORAL | 218316 | NDA | Novo Nordisk Pharmaceutical Industries, LP | 0169-4404 | 0169-4404-31 | 30 TABLET in 1 BOTTLE, PLASTIC (0169-4404-31) |
| WEGOVY | semaglutide | TABLET;ORAL | 218316 | NDA | Novo Nordisk Pharmaceutical Industries, LP | 0169-4409 | 0169-4409-31 | 30 TABLET in 1 BOTTLE, PLASTIC (0169-4409-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1.5MG | ||||
| Approval Date: | Dec 22, 2025 | 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 22, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | May 2, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF WEIGHT REDUCTION AND MAINTENANCE OF WEIGHT REDUCTION VIA ORAL ADMINISTRATION | ||||||||
Expired US Patents for NDA 218316
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novo | WEGOVY | semaglutide | TABLET;ORAL | 218316-004 | Dec 22, 2025 | ⤷ Start Trial | ⤷ Start Trial |
| Novo | WEGOVY | semaglutide | TABLET;ORAL | 218316-003 | Dec 22, 2025 | ⤷ Start Trial | ⤷ Start Trial |
| Novo | WEGOVY | semaglutide | TABLET;ORAL | 218316-001 | Dec 22, 2025 | ⤷ Start Trial | ⤷ Start Trial |
| Novo | WEGOVY | semaglutide | TABLET;ORAL | 218316-002 | Dec 22, 2025 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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