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Serving leading biopharmaceutical companies globally:

Dow
QuintilesIMS
Queensland Health
Citi
Argus Health
Merck
Cerilliant
US Department of Justice
Moodys
McKinsey

Generated: January 17, 2018

DrugPatentWatch Database Preview

apidra Drug Profile

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

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

This drug has eighty-seven patent family members in thirty-nine countries.

The generic ingredient in APIDRA is insulin glulisine recombinant. There are thirty-eight 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
International Patents:87
US Patents:4
Applicants:1
NDAs:1
Suppliers / Packagers: 1
Clinical Trials: 52
Drug Prices:see details
DailyMed Link:apidra at DailyMed
Drug patent expirations by year for apidra
Pharmacology for apidra
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for apidra

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 ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021629-001 Apr 16, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021629-002 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021629-001 Apr 16, 2004 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us APIDRA SOLOSTAR insulin glulisine recombinant INJECTABLE;SUBCUTANEOUS 021629-003 Feb 24, 2009 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Sanofi Aventis Us APIDRA insulin glulisine recombinant INJECTABLE;IV (INFUSION), SUBCUTANEOUS 021629-002 Dec 20, 2005 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
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

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
7,205,276 Zinc-free and low-zinc insulin preparations having improved stability ➤ Subscribe
7,205,277 Zinc-free and low-zinc insulin preparations having improved stability ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for apidra

Supplementary Protection Certificates for apidra

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004005,C0792290 Lithuania ➤ Subscribe 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
00596 Netherlands ➤ Subscribe PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001EU/1/12/807/004EU/1/12/807/005EU/1/12/807/007EU/1/12/807/008EU/1/12/807/009EU/1/12/807/012EU/1/12/807/013EU/1/12/807/015 2013210121
91022-0 Sweden ➤ Subscribe PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
0880 Netherlands ➤ Subscribe PRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
13/034 Ireland ➤ Subscribe APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
C/GB96/036 United Kingdom ➤ Subscribe PRODUCT NAME: INSULIN LISPRO, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY-ACCEPTABLE SALT; REGISTERED: CH 53290 19951123; CH 53553 19951123; UK EU/1/96/007/001 19960430; UK EU/1/96/007/002 19960430; UK EU/1/96/007/003 19960430
2004005 Lithuania ➤ Subscribe PRODUCT NAME: INSULIN DETEMIR
C0009 France ➤ Subscribe PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
C/GB05/024 United Kingdom ➤ Subscribe PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
/2004 Austria ➤ Subscribe PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Moodys
Daiichi Sankyo
Colorcon
Farmers Insurance
McKinsey
Deloitte
UBS
Medtronic

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