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Last Updated: January 28, 2020

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HUMULIN 70/30 Drug Profile

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Which patents cover Humulin 70/30, and what generic alternatives are available?

Humulin 70/30 is a drug marketed by Lilly and is included in one NDA. There is one patent protecting this drug.

This drug has eighteen patent family members in fourteen countries.

The generic ingredient in HUMULIN 70/30 is insulin recombinant human; insulin susp isophane recombinant 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 recombinant human; insulin susp isophane recombinant human profile page.

US ANDA Litigation and Generic Entry Outlook for Humulin 70/30

Humulin 70/30 was eligible for patent challenges on December 31, 1968.

Annual sales in 2017 were $1mm indicating the motivation for generic entry (peak sales were $214mm in 2009).

Indicators of Generic Entry

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Drug patent expirations by year for HUMULIN 70/30
Drug Sales Revenue Trends for HUMULIN 70/30

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Recent Clinical Trials for HUMULIN 70/30

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Centre hospitalier de l'Université de Montréal (CHUM)Phase 1
HealthPartners InstitutePhase 2
International Diabetes Center at Park NicolletPhase 2

See all HUMULIN 70/30 clinical trials

Synonyms for HUMULIN 70/30
1021924-27-5
1038820-20-0
1104460-98-1
11061-68-0
1146625-72-0
1171191-96-0
1171210-94-8
1171228-96-8
1171244-30-6
1245604-13-0
1Y17CTI5SR
Actrapid
Actrapid HM
Biohulin
H-Tronin
Human Protaphane
IN 105
Incelligent AF
Incelligent SG
Insugen
Insulin human (biosynthesis)
Insulin human [USAN:USP:INN:BAN]
Insulin U-500
Insulin, Regular, Human
Insulin(human)
Insulina humana
Insuline humaine
Insulinum humanum
Insuman Rapid
Isuhuman
Jusuline
NN 1953
Novolin
Oral-lyn
ORMD 0801
Regular human insulin
Umulin
Umulin Rapide
UNII-1Y17CTI5SR
Velosulin HM
Velosuline HM
Viaject

US Patents and Regulatory Information for HUMULIN 70/30

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly HUMULIN 70/30 insulin recombinant human; insulin susp isophane recombinant human INJECTABLE;INJECTION 019717-001 Apr 25, 1989 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
Lilly HUMULIN 70/30 PEN insulin recombinant human; insulin susp isophane recombinant human INJECTABLE;INJECTION 019717-002 Aug 6, 1998 OTC Yes Yes   Start Trial   Start Trial Y   Start Trial
>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 70/30

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 C300596 Netherlands   Start Trial PRODUCT 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
2340033 122017000040 Germany   Start Trial PRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
0368187 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609
2107069 C02107069/02 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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