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Last Updated: October 27, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206321


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NDA 206321 describes SAXENDA, which is a drug marketed by Novo and is included in one NDA. It is available from two suppliers. There are twenty-two patents protecting this drug. Additional details are available on the SAXENDA profile page.

The generic ingredient in SAXENDA is liraglutide recombinant. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the liraglutide recombinant profile page.
Summary for 206321
Tradename:SAXENDA
Applicant:Novo
Ingredient:liraglutide recombinant
Patents:22
Formulation / Manufacturing:see details
DrugPatentWatch® Estimated Generic Entry Opportunity Date for 206321
Generic Entry Date for 206321*:
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: 206321
Medical Subject Heading (MeSH) Categories for 206321
Suppliers and Packaging for NDA: 206321
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321 NDA Novo Nordisk 0169-2800 0169-2800-15 5 SYRINGE, PLASTIC in 1 CARTON (0169-2800-15) > 3 mL in 1 SYRINGE, PLASTIC
SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321 NDA Novo Nordisk 0169-2800 0169-2800-90 1 SYRINGE, PLASTIC in 1 CARTON (0169-2800-90) > 3 mL in 1 SYRINGE, PLASTIC
Paragraph IV (Patent) Challenges for 206321
Tradename Dosage Ingredient NDA Submissiondate
SAXENDA SOLUTION;SUBCUTANEOUS liraglutide recombinant 206321 2021-08-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength18MG/3ML (6MG/ML)
Approval Date:Dec 23, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 4, 2023
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:⤷  Try it FreePatent Expiration:Jan 17, 2027Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try it FreePatent Expiration:Jan 20, 2026Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 206321

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 ⤷  Try it Free ⤷  Try it Free
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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