Details for New Drug Application (NDA): 209637
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NDA 209637 describes OZEMPIC, which is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are twenty-one patents protecting this drug. Additional details are available on the OZEMPIC profile page.
The generic ingredient in OZEMPIC is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.
The generic ingredient in OZEMPIC is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.
Summary for 209637
| Tradename: | OZEMPIC |
| Applicant: | Novo |
| Ingredient: | semaglutide |
| Patents: | 21 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209637
Generic Entry Date for 209637*:
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: 209637
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
Suppliers and Packaging for NDA: 209637
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637 | NDA | Novo Nordisk | 0169-4130 | 0169-4130-13 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-4130-13) / 3 mL in 1 SYRINGE, PLASTIC (0169-4130-01) |
| OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637 | NDA | Novo Nordisk | 0169-4132 | 0169-4132-12 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-4132-12) / 1.5 mL in 1 SYRINGE, PLASTIC (0169-4132-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 2MG/1.5ML (1.34MG/ML) | ||||
| Approval Date: | Dec 5, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jul 17, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 21, 2033 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | A METHOD OF TREATING TYPE 2 DIABETES COMPRISING ADMINISTERING SEMAGLUTIDE ONCE WEEKLY IN A AMOUNT OF 1.0 MG TO A SUBJECT IN NEED THEREOF | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jan 20, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 209637
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-001 | Dec 5, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-001 | Dec 5, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-002 | Apr 9, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-001 | Dec 5, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-003 | Mar 28, 2022 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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