Insulin aspart - Biologic Drug Details

Summary for insulin aspart

Tradenames:	2
High Confidence Patents:	18
Applicants:	1
BLAs:	4
Suppliers: see list	4
Recent Clinical Trials:	See clinical trials for insulin aspart
Drug Prices:	Drug price information for insulin aspart
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for insulin aspart

Recent Clinical Trials for insulin aspart

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Gan and Lee Pharmaceuticals, USA	Phase 2
Sunshine Lake Pharma Co., Ltd.	Phase 3
Sun Yat-sen University	Phase 4

See all insulin aspart clinical trials

Recent Litigation for insulin aspart

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.	2024-02-05
Novo Nordisk, Inc. v. Mylan Pharmaceuticals, Inc.	2022-08-08
In Re: Ozempic (Semaglutide) Patent Litigation	2022-08-05

See all insulin aspart litigation

Pharmacology for insulin aspart

Established Pharmacologic Class	Insulin Analog
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 aspart Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin aspart 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.	NOVOLOG	insulin aspart	Injection	020986			Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2014-04-08	Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2014-05-06	Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2014-12-02	Company disclosures
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2016-06-20	Company disclosures

3) Low Certainty: US Patents for insulin aspart 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
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2025-05-23	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2033-03-11	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2034-12-01	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2034-07-21	Patent claims search
Novo Nordisk Inc.	NOVOLOG	insulin aspart	Injection	020986		2034-05-08	Patent claims search

International Patents for insulin aspart

Country	Patent Number	Estimated Expiration
Poland	2373361
Germany	602005017182
European Patent Office	2373361
Yugoslavia	4188
Japan	4361236

Supplementary Protection Certificates for insulin aspart

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
99C0044	Belgium		PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
SZ 40/2005	Austria		PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LÖSLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHÄLTNIS 50:50
35/2013	Austria		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC AND INSULIN ASPART UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, EU/1/12/806/008 (MITTEILUNG) 20180123
CA 2005 00046	Denmark		PRODUCT NAME: OPLOSELIGT INSULIN ASPART / PROTAMINKRYSTALLERET INSULIN ASPART 100E/ML I FORHOLDET 50/50
SPC/GB00/027	United Kingdom		PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801