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Last Updated: January 20, 2020

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ADMELOG SOLOSTAR Drug Profile

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

Admelog Solostar is a drug marketed by Sanofi-aventis Us and is included in one NDA. There are nineteen patents protecting this drug.

This drug has two hundred and twenty patent family members in twenty-eight countries.

The generic ingredient in ADMELOG SOLOSTAR is insulin lispro. There are forty drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the insulin lispro profile page.

US ANDA Litigation and Generic Entry Outlook for Admelog Solostar

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Admelog Solostar was eligible for patent challenges on December 31st, 1968.

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.

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

See drug prices for ADMELOG SOLOSTAR

Recent Litigation for ADMELOG 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 ADMELOG SOLOSTAR litigation

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

See all ADMELOG SOLOSTAR litigation

Pharmacology for ADMELOG SOLOSTAR
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for ADMELOG 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 ADMELOG SOLOSTAR insulin lispro SOLUTION;INTRAVENOUS, SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;INTRAVENOUS, SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;INTRAVENOUS, SUBCUTANEOUS 209196-002 Dec 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Sanofi-aventis Us ADMELOG SOLOSTAR insulin lispro SOLUTION;INTRAVENOUS, SUBCUTANEOUS 209196-002 Dec 11, 2017 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 ADMELOG SOLOSTAR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 1490067-4 Sweden   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2340033 300880 Netherlands   Start Trial PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
2498802 PA2017020 Lithuania   Start Trial PRODUCT NAME: INSULINAS GLARGINAS + LIKSIZENATIDAS; REGISTRATION NO/DATE: EU/1/16/1157 20170111
0792290 PA2004005 Lithuania   Start Trial PRODUCT NAME: INSULIN DETEMIR
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKesson
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