Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 16, 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 sixteen patent family members in twelve countries.

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

Drug patent expirations by year for HUMULIN R
Drug Prices for HUMULIN R

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Drug Sales Revenue Trends for HUMULIN R

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Recent Clinical Trials for HUMULIN R

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SponsorPhase
Centre hospitalier de l'Université de Montréal (CHUM)Phase 1
Juvenile Diabetes Research FoundationPhase 2
HealthPartners InstitutePhase 2

See all HUMULIN R clinical trials

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

Supplementary Protection Certificates for HUMULIN R

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2340033 2017C/024 Belgium   See Pricing PRODUCT NAME: SNELWERKENDE INSULINE ASPART; AUTHORISATION NUMBER AND DATE: EU/1/16/1160 20170111
2107069 SPC/GB13/037 United Kingdom   See Pricing PRODUCT NAME: INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, COMPLEXES, OR SALTS THEREOF; REGISTERED: UK EU/1/12/807/001 20130123; UK EU/1/12/807/004 20130123; UK EU/1/12/807/005 20130123; UK EU/1/12/807/007 20130123; UK EU/1/12/807/008 20130123; UK EU/1/12/807/009 20130123; UK EU/1/12/807/012 20130123; UK EU/1/12/807/013 20130123; UK EU/1/12/807/015 20130123
2597103 CR 2017 00013 Denmark   See Pricing PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
2107069 C02107069/01 Switzerland   See Pricing PRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
2209800 122014000114 Germany   See Pricing PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
0792290 C300160 Netherlands   See Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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