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Last Updated: January 27, 2020

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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 sixty-nine 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.

US ANDA Litigation and Generic Entry Outlook for Apidra Solostar

Apidra Solostar was eligible for patent challenges on April 16, 2008.

There have been six patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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

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Recent Clinical Trials for APIDRA SOLOSTAR

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

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
Allergan Sales, LLC v. Teva Pharmaceuticals USA, Inc.2016-11-30
Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp.2016-09-16

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
>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
2107069 2013/34 Ireland   Start Trial PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
2107069 2013C/038 Belgium   Start Trial PRODUCT NAME: RYZODEG-INSULINE DEGLUDEC/INSULINE ASPARTE; AUTHORISATION NUMBER AND DATE: EU/1/12/806/001 20130121
2498802 PA2017020 Lithuania   Start Trial PRODUCT NAME: INSULINAS GLARGINAS + LIKSIZENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
2209800 C300698 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
2498802 2017/022 Ireland   Start Trial PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111
0792290 SPC/GB04/036 United Kingdom   Start Trial PRODUCT NAME: INSULIN DETEMIR, NEB29- TETRADECANOYL- DES(B30) HUMAN INSULIN; NATL REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: CH 56370, 56311, 56372 20031110
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Johnson and Johnson
Moodys
Medtronic
McKinsey
Merck

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