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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Boehringer Ingelheim
Harvard Business School
Fuji
Deloitte
Johnson and Johnson
Chubb
Colorcon
McKinsey
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Generated: August 20, 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.

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

Summary for Generic Name: insulin human

Tradenames:2
Patents:1
Applicants:1
NDAs:1
Drug Master File Entries: see list38
Suppliers / Packagers: see list2
Clinical Trials: see list11,073
Therapeutic Class:Blood Glucose Regulators
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:insulin human at DailyMed

Pharmacology for Ingredient: insulin human

Ingredient-typeInsulin
Drug ClassInsulin
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly
HUMULIN R KWIKPEN
insulin human
SOLUTION;SUBCUTANEOUS018780-002Dec 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Lilly
HUMULIN R
insulin human
SOLUTION;SUBCUTANEOUS018780-004Mar 31, 1994RXYesYes► Subscribe► SubscribeY ► 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
China1835774► Subscribe
South Africa200601093► Subscribe
Australia2004266131► Subscribe
South Korea101121317► Subscribe
Canada2530263► 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
C0020France► SubscribePRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
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
00597Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
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
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
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Serving 500+ biopharmaceutical companies globally:

UBS
Federal Trade Commission
Cerilliant
Cantor Fitzgerald
Healthtrust
Chubb
Merck
QuintilesIMS
Daiichi Sankyo
AstraZeneca

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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