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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
US Army
Federal Trade Commission
Moodys
Baxter
Merck
UBS
Colorcon
Queensland Health

Generated: February 23, 2019

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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 forty 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 HUMULIN R
Drug patent expirations by year for HUMULIN R
Pharmacology for HUMULIN R
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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Supplementary Protection Certificates for HUMULIN R

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2004 Austria ➤ Sign Up PRODUCT 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
2017000040 Germany ➤ Sign Up PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
C0023 France ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
2107069/02 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
34/2000 Austria ➤ Sign Up PRODUCT NAME: LANTUS - INSULIN GLARGIN
2013000061 Germany ➤ Sign Up PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Harvard Business School
Accenture
Healthtrust
US Department of Justice
Moodys
Boehringer Ingelheim
US Army
Colorcon

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