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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
UBS
Mallinckrodt
Fuji
AstraZeneca
US Department of Justice
Chinese Patent Office
US Army
Fish and Richardson

Generated: April 19, 2018

DrugPatentWatch Database Preview

apidra solostar Drug Profile

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When do Apidra Solostar patents expire, 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 seventy-three patent family members in forty-two countries.

The generic ingredient in APIDRA SOLOSTAR is insulin glulisine recombinant. There are thirty-nine 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.
Summary for apidra solostar
International Patents:273
US Patents:22
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 30
Drug Prices:see details
DailyMed Link:apidra solostar at DailyMed
Drug patent expirations by year for apidra solostar
Pharmacology for apidra solostar
Ingredient-typeInsulin
Drug ClassInsulin Analog

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 ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ 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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Non-Orange Book US Patents for apidra solostar

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,205,197 Drug delivery device dose setting mechanism ➤ Try a Free Trial
9,526,843 Drive mechanisms suitable for use in drug delivery devices ➤ Try a Free Trial
7,205,276 Zinc-free and low-zinc insulin preparations having improved stability ➤ Try a Free Trial
8,070,727 Drive mechanisms suitable for use in drug delivery devices ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for apidra solostar

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0170 Netherlands ➤ Try a Free Trial 300170, 20180615, EXPIRES: 20190927
C0085 France ➤ Try a Free Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
0596 Netherlands ➤ Try a Free Trial PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
34/2000 Austria ➤ Try a Free Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
McKesson
Cipla
Healthtrust
Covington
Harvard Business School
UBS
McKinsey
Dow

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