.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Drug patents in 130+ countries

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Express Scripts
Farmers Insurance
Queensland Health
Julphar
Baxter
McKesson
Daiichi Sankyo
Mallinckrodt
Medtronic
Harvard Business School

Generated: December 13, 2017

DrugPatentWatch Database Preview

Insulin lispro recombinant - Generic Drug Details

« Back to Dashboard

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-three patent family members in thirty-one countries and forty-two supplementary protection certificates in twelve countries.

There are thirty-eight drug master file entries for insulin lispro recombinant. Three suppliers are listed for this compound.

Summary for insulin lispro recombinant

Pharmacology for insulin lispro recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog

Medical Subject Heading (MeSH) Categories for insulin lispro recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Eli Lilly And CoHUMALOG KWIKPENinsulin lispro recombinantSOLUTION;SUBCUTANEOUS205747-001May 26, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Eli Lilly And CoHUMALOG KWIKPENinsulin lispro recombinantSOLUTION;SUBCUTANEOUS205747-001May 26, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
LillyHUMALOG KWIKPENinsulin lispro recombinantINJECTABLE;INJECTION020563-003Sep 6, 2007RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Eli Lilly And CoHUMALOG KWIKPENinsulin lispro recombinantSOLUTION;SUBCUTANEOUS205747-001May 26, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
LillyHUMALOG PENinsulin lispro recombinantINJECTABLE;INJECTION020563-002Aug 6, 1998DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
LillyHUMALOGinsulin lispro recombinantINJECTABLE;INJECTION020563-001Jun 14, 1996RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: insulin lispro recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
LillyHUMALOGinsulin lispro recombinantINJECTABLE;INJECTION020563-001Jun 14, 1996► Subscribe► Subscribe
LillyHUMALOG PENinsulin lispro recombinantINJECTABLE;INJECTION020563-002Aug 6, 1998► Subscribe► Subscribe
LillyHUMALOG KWIKPENinsulin lispro recombinantINJECTABLE;INJECTION020563-003Sep 6, 2007► Subscribe► Subscribe
LillyHUMALOG PENinsulin lispro recombinantINJECTABLE;INJECTION020563-002Aug 6, 1998► Subscribe► Subscribe
LillyHUMALOG KWIKPENinsulin lispro recombinantINJECTABLE;INJECTION020563-003Sep 6, 2007► Subscribe► Subscribe
LillyHUMALOGinsulin lispro recombinantINJECTABLE;INJECTION020563-001Jun 14, 1996► Subscribe► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: 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
7,427,275Medication dispensing apparatus with triple screw threads for mechanical advantage► Subscribe
6,906,028 Stable insulin formulations► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: insulin lispro recombinant

Country Document Number Estimated Expiration
Spain2264713► Subscribe
Australia734781► Subscribe
Ukraine61109► Subscribe
Austria226088► Subscribe
Denmark0884053► Subscribe
Poland194244► Subscribe
Germany69834956► Subscribe
South Africa200601093► Subscribe
Czech Republic299637► Subscribe
Japan2007502146► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: INSULIN LISPRO RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00596Netherlands► SubscribePRODUCT 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
2017 00013Denmark► SubscribePRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
2107069/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
2107069/02Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
00698Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
0880Netherlands► SubscribePRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
2017000040Germany► SubscribePRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
2013000062Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
C/GB04/036United Kingdom► SubscribePRODUCT 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

McKesson
Express Scripts
Deloitte
Cipla
Cerilliant
Merck
Johnson and Johnson
Colorcon
Novartis
Dow

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot