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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Citi
Dow
Medtronic
Daiichi Sankyo
Boehringer Ingelheim
Healthtrust
Mallinckrodt
Johnson and Johnson
Moodys

Generated: February 17, 2018

DrugPatentWatch Database Preview

HUMULIN R Drug Profile

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When do Humulin R patents expire, and what generic 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-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the insulin human profile page.
Summary for HUMULIN R
International Patents:12
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 3
Clinical Trials: 20
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:HUMULIN R at DailyMed
Drug patent expirations by year for HUMULIN R
Pharmacology for HUMULIN R
Ingredient-typeInsulin
Drug ClassInsulin

US Patents and Regulatory Information for HUMULIN R

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;INJECTION 018780-001 Oct 28, 1982 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly HUMULIN R PEN insulin recombinant human INJECTABLE;INJECTION 018780-005 Aug 6, 1998 OTC Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lilly HUMULIN R insulin human SOLUTION;SUBCUTANEOUS 018780-004 Mar 31, 1994 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Lilly HUMULIN R KWIKPEN insulin human SOLUTION;SUBCUTANEOUS 018780-002 Dec 29, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
7,427,275 Medication dispensing apparatus with triple screw threads for mechanical advantage ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for HUMULIN R

Supplementary Protection Certificates for HUMULIN R

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90067-4 Sweden ➤ Sign Up PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2107069/02 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
2/2005 Austria ➤ Sign Up PRODUCT NAME: INSULIN GLULISINE
2017 00013 Denmark ➤ Sign Up PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
90029-5 Sweden ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEK
0596 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
2017000040 Germany ➤ Sign Up PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
91022-0 Sweden ➤ Sign Up PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
90042 Netherlands ➤ Sign Up PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
00160 Netherlands ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Fuji
Johnson and Johnson
Farmers Insurance
QuintilesIMS
US Department of Justice
Julphar
Cantor Fitzgerald
Express Scripts

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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