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Last Updated: July 11, 2020

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Insulin glargine recombinant - Generic Drug Details

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What are the generic sources for insulin glargine recombinant and what is the scope of freedom to operate?

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

Insulin glargine recombinant has two hundred and sixty-nine patent family members in forty-four countries.

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

Summary for insulin glargine recombinant
Recent Clinical Trials for insulin glargine recombinant

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Max super speciality hospitals New DelhiPhase 4
All India institute of medical sciences, RaipurPhase 4
Institute of Post-Graduate Medical Education and Research, KolkataPhase 4

See all insulin glargine recombinant clinical trials

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

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

Supplementary Protection Certificates for insulin glargine recombinant

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 SPC/GB14/079 United Kingdom   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF, AND LIRAGLUTIDE, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF; REGISTERED: CH 65041 20140912; UK EU/1/14/947 20140922
2209800 14C0085 France   Start Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2107069 C300597 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
0705275 40/2005 Austria   Start Trial PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
AstraZeneca
McKinsey
Johnson and Johnson
Merck
Baxter

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