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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Teva
Farmers Insurance
McKinsey
Healthtrust
Deloitte
Johnson and Johnson
Colorcon
Fuji
Citi

Generated: February 25, 2018

DrugPatentWatch Database Preview

Insulin lispro recombinant - Generic Drug Details

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What are the generic drug sources for insulin lispro recombinant and what is the scope of insulin lispro recombinant freedom to operate?

Insulin lispro recombinant
is the generic ingredient in three branded drugs marketed by Lilly and Eli Lilly And Co, and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin lispro recombinant has fifty-five patent family members in thirty-one countries.

There are thirty-nine drug master file entries for insulin lispro recombinant. Four suppliers are listed for this compound.
Summary for insulin lispro recombinant
International Patents:55
US Patents:3
Tradenames:3
Applicants:2
NDAs:2
Drug Master File Entries: 39
Suppliers / Packagers: 4
Clinical Trials: 4,098
Drug Prices:see low prices
DailyMed Link:insulin lispro recombinant at DailyMed
Pharmacology for insulin lispro recombinant
Ingredient-typeInsulin
Drug ClassInsulin Analog
Medical Subject Heading (MeSH) Categories for insulin lispro recombinant

US Patents and Regulatory Information for insulin lispro recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And Co HUMALOG KWIKPEN insulin lispro recombinant SOLUTION;SUBCUTANEOUS 205747-001 May 26, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Eli Lilly And Co HUMALOG KWIKPEN insulin lispro recombinant SOLUTION;SUBCUTANEOUS 205747-001 May 26, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly HUMALOG PEN insulin lispro recombinant INJECTABLE;INJECTION 020563-002 Aug 6, 1998 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Eli Lilly And Co HUMALOG KWIKPEN insulin lispro recombinant SOLUTION;SUBCUTANEOUS 205747-001 May 26, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly HUMALOG KWIKPEN insulin lispro recombinant INJECTABLE;INJECTION 020563-003 Sep 6, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly HUMALOG insulin lispro recombinant INJECTABLE;INJECTION 020563-001 Jun 14, 1996 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Expired US Patents for insulin lispro recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly HUMALOG insulin lispro recombinant INJECTABLE;INJECTION 020563-001 Jun 14, 1996 ➤ Sign Up ➤ Sign Up
Lilly HUMALOG KWIKPEN insulin lispro recombinant INJECTABLE;INJECTION 020563-003 Sep 6, 2007 ➤ Sign Up ➤ Sign Up
Lilly HUMALOG PEN insulin lispro recombinant INJECTABLE;INJECTION 020563-002 Aug 6, 1998 ➤ Sign Up ➤ Sign Up
Lilly HUMALOG PEN insulin lispro recombinant INJECTABLE;INJECTION 020563-002 Aug 6, 1998 ➤ Sign Up ➤ Sign Up
Lilly HUMALOG insulin lispro recombinant INJECTABLE;INJECTION 020563-001 Jun 14, 1996 ➤ Sign Up ➤ Sign Up
Lilly HUMALOG KWIKPEN insulin lispro recombinant INJECTABLE;INJECTION 020563-003 Sep 6, 2007 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for insulin lispro recombinant

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
7,427,275 Medication dispensing apparatus with triple screw threads for mechanical advantage ➤ Sign Up
6,906,028 Stable insulin formulations ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for insulin lispro recombinant

Supplementary Protection Certificates for insulin lispro recombinant

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004005,C0792290 Lithuania ➤ Sign Up 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
0885961/01 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
90029-5 Sweden ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEK
/2000 Austria ➤ Sign Up PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
00698 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
C0035 France ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
13/34 Ireland ➤ Sign Up 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
2209800/01 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
C0085 France ➤ Sign Up PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
91022-0 Sweden ➤ Sign Up PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
QuintilesIMS
Teva
Colorcon
Chubb
Daiichi Sankyo
Fuji
Citi
Merck

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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