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Generated: February 23, 2019

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LANTUS Drug Profile

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Which patents cover Lantus, and what generic alternatives are available?

Lantus is a drug marketed by Sanofi Aventis Us and is included in one NDA. There are twenty-one patents protecting this drug.

This drug has two hundred and thirty-two patent family members in forty-four countries.

The generic ingredient in LANTUS is insulin glargine recombinant. There are forty 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.

Drug patent expirations by year for LANTUS
Pharmacology for LANTUS
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for LANTUS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sanofi Aventis Us LANTUS SOLOSTAR insulin glargine recombinant INJECTABLE;INJECTION 021081-002 Apr 27, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for LANTUS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000 ➤ Sign Up ➤ Sign Up
Sanofi Aventis Us LANTUS insulin glargine recombinant INJECTABLE;INJECTION 021081-001 Apr 20, 2000 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for LANTUS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2004 Austria ➤ Sign Up PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
2017000040 Germany ➤ Sign Up PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
C0023 France ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
2107069/02 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
34/2000 Austria ➤ Sign Up PRODUCT NAME: LANTUS - INSULIN GLARGIN
2013000061 Germany ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Healthtrust
Johnson and Johnson
Daiichi Sankyo
Merck
Accenture
US Department of Justice
Argus Health
Federal Trade Commission

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