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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Cantor Fitzgerald
AstraZeneca
Boehringer Ingelheim
QuintilesIMS
Express Scripts
Medtronic
Fish and Richardson
Teva

Generated: April 20, 2018

DrugPatentWatch Database Preview

HUMULIN N Drug Profile

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Which patents cover Humulin N, and what generic alternatives are available?

Humulin N 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 N is insulin susp isophane recombinant human. There are thirty-nine drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the insulin susp isophane recombinant human profile page.
Summary for HUMULIN N
International Patents:12
US Patents:1
Applicants:1
NDAs:1
Suppliers / Packagers: 3
Clinical Trials: 20
Drug Prices:see details
DailyMed Link:HUMULIN N at DailyMed
Drug patent expirations by year for HUMULIN N

US Patents and Regulatory Information for HUMULIN N

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lilly HUMULIN N insulin susp isophane recombinant human INJECTABLE;INJECTION 018781-001 Oct 28, 1982 OTC Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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 N

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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Supplementary Protection Certificates for HUMULIN N

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004005,C0792290 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
2013000062 Germany ➤ Sign Up PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
C0020 France ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
C0035 France ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
AstraZeneca
Merck
Dow
Colorcon
Johnson and Johnson
Medtronic
Chinese Patent Office
Moodys

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