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Last Updated: April 22, 2024

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.
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
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:RXDosage:SOLUTION;SUBCUTANEOUSStrength2MG/1.5ML (1.34MG/ML)
Approval Date:Dec 5, 2017TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jul 17, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Jun 21, 2033Product 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 TrialPatent Expiration:Jan 20, 2026Product Flag?YSubstance 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.