Insulin human - Biologic Drug Details

Summary for insulin human

Tradenames:	5
High Confidence Patents:	10
Applicants:	4
BLAs:	4
Suppliers: see list	5
Recent Clinical Trials:	See clinical trials for insulin human
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for insulin human

Recent Clinical Trials for insulin human

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Pichamol Jirapinyo, MD, MPH	Phase 4
Valeo Pharma Inc	Phase 3
Western University, Canada	Phase 3

See all insulin human clinical trials

Recent Litigation for insulin human

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Pandora Marketing LLC	2024-01-31
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12

See all insulin human litigation

Pharmacology for insulin human

Established Pharmacologic Class	Insulin
Chemical Structure	Insulin

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for insulin human Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin human Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938			Company disclosures
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938		2014-05-06	Company disclosures
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938		2014-12-02	Company disclosures
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938		2016-07-05	Company disclosures
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938			Company disclosures
Novo Nordisk Inc.	NOVOLIN R	insulin human	Injection	019938		2010-09-21	Company disclosures

3) Low Certainty: US Patents for insulin human Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780		2025-05-23	Patent claims search
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780		2034-12-02	Patent claims search
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780		2034-05-15	Patent claims search
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780		2028-03-18	Patent claims search
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780		2034-10-14	Patent claims search
Eli Lilly And Company	HUMULIN R U-100	insulin human	Injection	018780		2040-04-01	Patent claims search

International Patents for insulin human

Country	Patent Number	Estimated Expiration
Canada	2258491
South Korea	20030020299
Denmark	1570876
Spain	2073173
South Korea	100709485
European Patent Office	0499613