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Serving leading biopharmaceutical companies globally:

Federal Trade Commission
QuintilesIMS
Baxter
Colorcon
Daiichi Sankyo
Argus Health
US Army
Cipla
Chubb
US Department of Justice

Generated: November 24, 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 and forty-two supplementary protection certificates in twelve countries.

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

Pharmacology for 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
Japan2007502146► Subscribe
South Korea101121317► Subscribe
Norway20061150► Subscribe
China1835774► Subscribe
China100531813► Subscribe
South Korea20060061822► Subscribe
European Patent Office1656170► Subscribe
Canada2530263► Subscribe
South Africa200601093► Subscribe
Japan4718462► 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
90029-5Sweden► SubscribePRODUCT NAME: INSULIN DEGLUDEK
2107069/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
0880Netherlands► SubscribePRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
/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
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
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
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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
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Serving leading biopharmaceutical companies globally:

Argus Health
Harvard Business School
Chinese Patent Office
Medtronic
Cipla
Healthtrust
Baxter
Colorcon
Farmers Insurance
Fish and Richardson

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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