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Serving leading biopharmaceutical companies globally:

Deloitte
Fuji
AstraZeneca
Cerilliant
Cipla
Julphar
Moodys
McKinsey
Queensland Health
Merck

Generated: December 15, 2017

DrugPatentWatch Database Preview

Insulin human - Generic Drug Details

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

Insulin human
is the generic ingredient in two branded drugs marketed by Lilly and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin human has twelve patent family members in nine countries and forty-two supplementary protection certificates in twelve countries.

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

Pharmacology for insulin human

Ingredient-typeInsulin
Drug ClassInsulin
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
LillyHUMULIN Rinsulin humanSOLUTION;SUBCUTANEOUS018780-004Mar 31, 1994RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
LillyHUMULIN R KWIKPENinsulin humanSOLUTION;SUBCUTANEOUS018780-002Dec 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin human

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
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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.

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International Patent Family for Ingredient: insulin human

Country Document Number Estimated Expiration
South Africa200601093► Subscribe
Norway20061150► Subscribe
Japan4718462► Subscribe
Australia2004266131► Subscribe
South Korea101121317► Subscribe
World Intellectual Property Organization (WIPO)2005018721► Subscribe
Japan2007502146► Subscribe
China1835774► Subscribe
China100531813► Subscribe
European Patent Office1656170► Subscribe
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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.

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Supplementary Protection Certificates for Tradename: INSULIN HUMAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00160Netherlands► SubscribePRODUCT NAME: INSULINE DETEMIRUM; NAT. REGISTRATION NO/DATE: EU/1/04/278/001EU/1/04/278/002EU/1/04/278/003EU/1/04/278/005EU/1/04/278/004EU/1/04/278/006EU/1/04/278/007EU/1/04/278/008EU/1/04/278/009 2004010601; FIRST REGISTRATION: 563705637156372EU/1/04/278/001 T/M -/009 2003101110
C/GB00/027United Kingdom► SubscribePRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
90029-5Sweden► SubscribePRODUCT NAME: INSULIN DEGLUDEK
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
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
0885961/01Switzerland► SubscribePRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
C/GB96/036United Kingdom► SubscribePRODUCT 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
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
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
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
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Serving leading biopharmaceutical companies globally:

Harvard Business School
Express Scripts
Cantor Fitzgerald
Johnson and Johnson
Federal Trade Commission
Fuji
Medtronic
Farmers Insurance
Accenture
Daiichi Sankyo

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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