.

Make Better Decisions

  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

Healthtrust
Accenture
Chubb
AstraZeneca
Cantor Fitzgerald
Covington
QuintilesIMS
Express Scripts
Baxter
Fuji

Generated: September 25, 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 Eli Lilly And Co and Lilly, 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 forty-nine patent family members in thirty-one countries.

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

Summary for Generic Name: insulin lispro recombinant

Tradenames:3
Patents:3
Applicants:2
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packagers: see list3
Clinical Trials: see list5,440
Drug Prices:see low prices
DailyMed Link:insulin lispro recombinant at DailyMed

Pharmacology for Ingredient: insulin lispro recombinant

Ingredient-typeInsulin
Drug ClassInsulin Analog
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;SUBCUTANEOUS205747-001May 26, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Eli Lilly And Co
HUMALOG KWIKPEN
insulin lispro recombinant
SOLUTION;SUBCUTANEOUS205747-001May 26, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Lilly
HUMALOG
insulin lispro recombinant
INJECTABLE;INJECTION020563-001Jun 14, 1996RXYesYes► Subscribe► Subscribe► Subscribe
Eli Lilly And Co
HUMALOG KWIKPEN
insulin lispro recombinant
SOLUTION;SUBCUTANEOUS205747-001May 26, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Lilly
HUMALOG PEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-002Aug 6, 1998DISCNNoNo► 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
Lilly
HUMALOG
insulin lispro recombinant
INJECTABLE;INJECTION020563-001Jun 14, 1996► Subscribe► Subscribe
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 2007► Subscribe► Subscribe
Lilly
HUMALOG KWIKPEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-003Sep 6, 2007► Subscribe► Subscribe
Lilly
HUMALOG PEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-002Aug 6, 1998► Subscribe► Subscribe
Lilly
HUMALOG
insulin lispro recombinant
INJECTABLE;INJECTION020563-001Jun 14, 1996► Subscribe► Subscribe
Lilly
HUMALOG PEN
insulin lispro recombinant
INJECTABLE;INJECTION020563-002Aug 6, 1998► 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
China100531813► Subscribe
European Patent Office1283051► Subscribe
Australia2004266131► Subscribe
Poland194244► Subscribe
Australia734781► Subscribe
Japan4718462► Subscribe
Indonesia24310► Subscribe
South Africa200601093► Subscribe
Ukraine61109► Subscribe
El Salvador1998000065► 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
13/034Ireland► SubscribeAPPLICATION 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
13/34Ireland► SubscribePRODUCT: 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
2004005,C0792290Lithuania► SubscribePRODUCT 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
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2107069/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
/2004Austria► SubscribePRODUCT 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
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
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
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 database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald
Chubb
Harvard Business School
US Army
Teva
Medtronic
Farmers Insurance
Cerilliant
Moodys

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 Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot