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Last Updated: January 26, 2020

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HUMALOG MIX 75/25 KWIKPEN Drug Profile

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Which patents cover Humalog Mix 75/25 Kwikpen, and when can generic versions of Humalog Mix 75/25 Kwikpen launch?

Humalog Mix 75/25 Kwikpen 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 HUMALOG MIX 75/25 KWIKPEN is insulin lispro protamine recombinant; insulin lispro recombinant. There are forty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin lispro protamine recombinant; insulin lispro recombinant profile page.

US ANDA Litigation and Generic Entry Outlook for Humalog Mix 75/25 Kwikpen

Humalog Mix 75/25 Kwikpen was eligible for patent challenges on December 31, 1968.

Indicators of Generic Entry

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Summary for HUMALOG MIX 75/25 KWIKPEN
Drug patent expirations by year for HUMALOG MIX 75/25 KWIKPEN
Recent Clinical Trials for HUMALOG MIX 75/25 KWIKPEN

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

SponsorPhase
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludPhase 4
Beta Bionics, Inc.Phase 2
Massachusetts General HospitalPhase 2

See all HUMALOG MIX 75/25 KWIKPEN clinical trials

Pharmacology for HUMALOG MIX 75/25 KWIKPEN
Ingredient-typeInsulin
Drug ClassInsulin Analog

US Patents and Regulatory Information for HUMALOG MIX 75/25 KWIKPEN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly HUMALOG MIX 75/25 KWIKPEN insulin lispro protamine recombinant; insulin lispro recombinant INJECTABLE;INJECTION 021017-002 Sep 6, 2007 RX 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

Expired US Patents for HUMALOG MIX 75/25 KWIKPEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lilly HUMALOG MIX 75/25 KWIKPEN insulin lispro protamine recombinant; insulin lispro recombinant INJECTABLE;INJECTION 021017-002 Sep 6, 2007   Start Trial   Start Trial
Lilly HUMALOG MIX 75/25 KWIKPEN insulin lispro protamine recombinant; insulin lispro recombinant INJECTABLE;INJECTION 021017-002 Sep 6, 2007   Start Trial   Start Trial
Lilly HUMALOG MIX 75/25 KWIKPEN insulin lispro protamine recombinant; insulin lispro recombinant INJECTABLE;INJECTION 021017-002 Sep 6, 2007   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for HUMALOG MIX 75/25 KWIKPEN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0368187 SZ 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
2107069 31/2013 Austria   Start Trial PRODUCT NAME: INSULIN DEGLUDEC UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/807/001, EU/1/12/807/004, EU/1/12/807/005, EU/1/12/807/007, EU/1/12/807/008, EU/1/12/807/009, EU/1/12/807/012, EU/1/12/807/013, EU/1/12/807/015 (MITTEILUNG) 20130123
0705275 32/2000 Austria   Start Trial PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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