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Generated: September 23, 2017

DrugPatentWatch Database Preview

HUMULIN R Drug Profile

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What is the patent landscape for Humulin R, and what generic Humulin R alternatives are available?

Humulin R is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug.

This drug has twelve patent family members in nine countries.

The generic ingredient in HUMULIN R is insulin human. There are thirty-eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the insulin human profile page.

Summary for Tradename: HUMULIN R

Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Clinical Trials: see list23
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:HUMULIN R at DailyMed

Pharmacology for Tradename: HUMULIN R

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
insulin recombinant human
INJECTABLE;INJECTION018780-001Oct 28, 1982OTCYesYes► Subscribe► Subscribe► Subscribe
Lilly
HUMULIN R PEN
insulin recombinant human
INJECTABLE;INJECTION018780-005Aug 6, 1998OTCYesYes► Subscribe► Subscribe► Subscribe
Lilly
HUMULIN R
insulin human
SOLUTION;SUBCUTANEOUS018780-004Mar 31, 1994RXYesYes► Subscribe► SubscribeY ► Subscribe
Lilly
HUMULIN R KWIKPEN
insulin human
SOLUTION;SUBCUTANEOUS018780-002Dec 29, 2015RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: HUMULIN R

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 Tradename: HUMULIN R

Country Document Number Estimated Expiration
China100531813► Subscribe
World Intellectual Property Organization (WIPO)2005018721► Subscribe
European Patent Office1656170► Subscribe
South Korea101121317► Subscribe
Australia2004266131► Subscribe
Japan4718462► Subscribe
South Africa200601093► Subscribe
South Korea20060061822► Subscribe
Norway20061150► Subscribe
China1835774► 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: HUMULIN R

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
213Luxembourg► SubscribePRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
60026Netherlands► SubscribePRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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
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
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
0885961/01Switzerland► SubscribePRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
AstraZeneca
Covington
Mallinckrodt
UBS
Julphar
Medtronic
Dow
Merck
Healthtrust

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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