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AstraZeneca
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QuintilesIMS
Chubb
Daiichi Sankyo
Citi
Harvard Business School
Cipla
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Generated: January 19, 2019

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Insulin glargine recombinant - Generic Drug Details

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What are the generic drug sources for insulin glargine recombinant and what is the scope of insulin glargine recombinant patent protection?

Insulin glargine recombinant is the generic ingredient in four branded drugs marketed by Sanofi Aventis Us and Sanofi Us Services, and is included in two NDAs. There are twenty-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin glargine recombinant has three hundred and nineteen patent family members in fifty countries.

There are forty drug master file entries for insulin glargine recombinant. Five suppliers are listed for this compound.

Summary for insulin glargine recombinant
Pharmacology for insulin glargine recombinant
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for insulin glargine recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Us Services TOUJEO MAX SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-002 Mar 26, 2018 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Us Services TOUJEO MAX SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-002 Mar 26, 2018 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Us Services TOUJEO MAX SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-002 Mar 26, 2018 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Us Services TOUJEO SOLOSTAR insulin glargine recombinant SOLUTION;SUBCUTANEOUS 206538-001 Feb 25, 2015 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 insulin glargine recombinant

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

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Supplementary Protection Certificates for insulin glargine recombinant

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
213 Luxembourg ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
C0085 France ➤ Try a Free Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
13/034 Ireland ➤ Try a Free Trial APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
2017 00013 Denmark ➤ Try a Free Trial PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
00160 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Baxter
Chinese Patent Office
US Army
Queensland Health
US Department of Justice
Teva
Citi
Healthtrust

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