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Last Updated: October 22, 2019

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APIDRA SOLOSTAR Drug Profile

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Which patents cover Apidra Solostar, and when can generic versions of Apidra Solostar launch?

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

This drug has two hundred and fifty-six patent family members in thirty-five countries.

The generic ingredient in APIDRA SOLOSTAR is insulin glulisine recombinant. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin glulisine recombinant profile page.

Drug patent expirations by year for APIDRA SOLOSTAR
Drug Prices for APIDRA SOLOSTAR

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Recent Clinical Trials for APIDRA SOLOSTAR

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SponsorPhase
SanofiPhase 4

See all APIDRA SOLOSTAR clinical trials

Recent Litigation for APIDRA SOLOSTAR

Identify potential future generic entrants

District Court Litigation
Case NameDate
SANOFI-AVENTIS U.S. LLC v. MYLAN N v.2017-10-24
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.2016-09-16
Sanofi-Aventis U.S. LLC v. Eli Lilly and Company2014-01-30

See all APIDRA SOLOSTAR litigation

PTAB Litigation
PetitionerDate
Pfizer Inc.2019-05-02
Mylan Pharmaceuticals Inc.2018-10-29
Mylan Pharmaceuticals Inc2018-09-10

See all APIDRA SOLOSTAR litigation

Pharmacology for APIDRA SOLOSTAR
Ingredient-typeInsulin
Drug ClassInsulin Analog
Synonyms for APIDRA SOLOSTAR
(3(sup B)-L-Lysine,29(sup B)-L-glutamic acid)insulin (human)
207748-29-6
7XIY785AZD
Apidra
B3-lysyl-B29-glutamylinsulin
HMR 1964
Insulin (human), 3B-L-lysine-29B-L-glutamic acid-
Insulin (human),3(sup B)-L-lysine,29(sup B)-L-glutamic acid-
Insulin glulisine [USAN:INN:JAN]
Insulin, Lys(B3)-Glu(B29)-
Insulin, lysyl(B3)-glutamyl(B29)-
UNII-7XIY785AZD

US Patents and Regulatory Information for APIDRA SOLOSTAR

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 APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No   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

Supplementary Protection Certificates for APIDRA SOLOSTAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0792290 0491022-0 Sweden   Start Trial PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2107069 C02107069/02 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
0792290 PA2004005,C0792290 Lithuania   Start Trial PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
2498802 PA2017020 Lithuania   Start Trial PRODUCT NAME: INSULINAS GLARGINAS + LIKSIZENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
2107069 C 2013 019 Romania   Start Trial PRODUCT NAME: INSULINA DEGLUDECIN TOATE FORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001; DATE OF FIRST AUTHORISATION IN EEA: 20130121
2107069 300596 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
0368187 SZ 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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