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Serving leading biopharmaceutical companies globally:

Mallinckrodt
US Army
Federal Trade Commission
Argus Health
Merck
US Department of Justice
Farmers Insurance
Citi
Colorcon
Chinese Patent Office

Generated: October 20, 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 four 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. Four suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.

Summary for NDA: 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 SOLOSTAR
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

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 Us
LANTUS
insulin glargine recombinant
INJECTABLE;INJECTION021081-001Apr 20, 2000► Subscribe► Subscribe
Sanofi Aventis Us
LANTUS
insulin glargine recombinant
INJECTABLE;INJECTION021081-001Apr 20, 2000► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Accenture
QuintilesIMS
Julphar
Mallinckrodt
Cantor Fitzgerald
Argus Health
Colorcon
Queensland Health
Novartis
Cipla

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