Details for New Drug Application (NDA): 209637
✉ Email this page to a colleague
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 nineteen 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: | 19 |
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 | 0169-4181 | 0169-4181-13 | 1 SYRINGE, PLASTIC in 1 CARTON (0169-4181-13) / 3 mL in 1 SYRINGE, PLASTIC (0169-4181-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 2MG/1.5ML (1.34MG/ML) | ||||
| Approval Date: | Dec 5, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 28, 2028 | ||||||||
| Regulatory Exclusivity Use: | TO REDUCE THE RISK OF SUSTAINED ESTIMATED GLOMERULAR FILTRATION RATE (EGFR) DECLINE, END-STAGE KIDNEY DISEASE, AND CARDIOVASCULAR DEATH IN ADULTS WITH TYPE 2 DIABETES MELLITUS AND CHRONIC KIDNEY DISEASE | ||||||||
| Patent: | 10,220,155 | Patent Expiration: | Jul 17, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | Y | |
| Patent: | 10,335,462 | 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 | ||||||||
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 | 8,684,969 | ⤷ Get Started Free |
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-003 | Mar 28, 2022 | 8,684,969 | ⤷ Get Started Free |
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-002 | Apr 9, 2019 | 8,684,969 | ⤷ Get Started Free |
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-001 | Dec 5, 2017 | 11,446,443 | ⤷ Get Started Free |
| Novo | OZEMPIC | semaglutide | SOLUTION;SUBCUTANEOUS | 209637-002 | Apr 9, 2019 | 6,899,699 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Complete Access Available with Subscription
