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BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

McKinsey
Julphar
QuintilesIMS
Baxter
Healthtrust
Argus Health
Fuji
Mallinckrodt
US Army
Fish and Richardson

Generated: December 17, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021081

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NDA 021081 describes LANTUS SOLOSTAR, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. It is available from five suppliers. There are sixteen patents protecting this drug. Additional details are available on the LANTUS SOLOSTAR profile page.

The generic ingredient in LANTUS SOLOSTAR is insulin glargine recombinant. There are thirty-eight drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.

Summary for 021081

Tradename:2
Applicant:1
Ingredient:1
Patents:19

Pharmacology for NDA: 021081

Ingredient-typeInsulin

Suppliers and Packaging for NDA: 021081

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081 NDA sanofi-aventis U.S. LLC 0088-2219 0088-2219-00 1 SYRINGE in 1 PACKAGE (0088-2219-00) > 3 mL in 1 SYRINGE
LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081 NDA sanofi-aventis U.S. LLC 0088-2219 0088-2219-05 5 SYRINGE in 1 PACKAGE (0088-2219-05) > 3 mL in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100 UNITS/ML
Approval Date:Apr 20, 2000TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jan 23, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Dec 13, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:► SubscribePatent Expiration:Mar 23, 2028Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 021081

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis UsLANTUSinsulin glargine recombinantINJECTABLE;INJECTION021081-001Apr 20, 2000► Subscribe► Subscribe
Sanofi Aventis UsLANTUSinsulin glargine recombinantINJECTABLE;INJECTION021081-001Apr 20, 2000► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Deloitte
Harvard Business School
Baxter
Healthtrust
Chinese Patent Office
Daiichi Sankyo
Moodys
QuintilesIMS
US Army

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.

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