Get our Free Drug Patent Expiration Updates

Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Johnson and Johnson
Federal Trade Commission
US Department of Justice
Queensland Health
Farmers Insurance

Generated: September 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208673

« Back to Dashboard

NDA 208673 describes SOLIQUA 100/33, which is a drug marketed by Sanofi-aventis Us and is included in one NDA. It is available from one supplier. There are twenty-five patents protecting this drug. Additional details are available on the SOLIQUA 100/33 profile page.

The generic ingredient in SOLIQUA 100/33 is insulin glargine; lixisenatide. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glargine; lixisenatide profile page.
Summary for 208673
Tradename:SOLIQUA 100/33
Applicant:Sanofi-aventis Us
Ingredient:insulin glargine; lixisenatide
Generic Entry Opportunity Date for 208673
Generic Entry Date for 208673*:
Constraining patent/regulatory exclusivity:

*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: 208673
Suppliers and Packaging for NDA: 208673
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLIQUA 100/33 insulin glargine; lixisenatide SOLUTION;SUBCUTANEOUS 208673 NDA Sanofi-Aventis U.S. LLC 0024-5761 0024-5761-05 5 SYRINGE in 1 CARTON (0024-5761-05) > 3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength300 UNITS/3ML;99MCG/3ML (100 UNITS/ML;33MCG/ML)
Approval Date:Nov 21, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 27, 2021
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Nov 21, 2019
Regulatory Exclusivity Use:NEW COMBINATION
Patent:➤ Try a Free TrialPatent Expiration:Aug 2, 2032Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Daiichi Sankyo

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 verifification 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.