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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 six suppliers. There are eight 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. Six suppliers are listed for this compound. Additional details are available on the insulin glargine recombinant profile page.

Summary for NDA: 021081

Tradename:
LANTUS
Applicant:
Sanofi Aventis Us
Ingredient:
insulin glargine recombinant
Patents:11

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:7,476,652*PEDPatent Expiration:Jan 23, 2024Product Flag?Substance Flag?Delist Request?Y
Patent:7,713,930*PEDPatent Expiration:Dec 13, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:7,918,833*PEDPatent 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, 20005,656,722*PED► subscribe
Sanofi Aventis Us
LANTUS
insulin glargine recombinant
INJECTABLE;INJECTION021081-001Apr 20, 20006,100,376*PED► subscribe
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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 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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