NOVOLOG MIX 50 Drug Profile

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. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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 NOVOLOG MIX 50 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NOVOLOG MIX 50 Derived from DrugPatentWatch Analysis and 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 MIX 50/50	insulin aspart protamine and insulin aspart	Injectable Suspension	021810		2026-07-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 50/50	insulin aspart protamine and insulin aspart	Injectable Suspension	021810		2037-11-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 50/50	insulin aspart protamine and insulin aspart	Injectable Suspension	021810		2037-02-24	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 50/50	insulin aspart protamine and insulin aspart	Injectable Suspension	021810		2039-01-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 50/50	insulin aspart protamine and insulin aspart	Injectable Suspension	021810		2039-06-25	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 50/50	insulin aspart protamine and insulin aspart	Injectable Suspension	021810		2013-09-28	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 50/50	insulin aspart protamine and insulin aspart	Injectable Suspension	021810		2006-08-29	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for NOVOLOG MIX 50 Derived from Patent Text Search

No patents found based on company disclosures

International Patents for NOVOLOG MIX 50

Country	Patent Number	Estimated Expiration
Austria	E447992
Australia	2006278928
Brazil	PI0613926
Canada	2616248
China	101227942
Germany	602006010396
Denmark	1909871

Supplementary Protection Certificates for NOVOLOG MIX 50

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
32/2000	Austria		PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
SPC/GB99/045	United Kingdom		SPC/GB99/045: 20060829, EXPIRES: 20110828
C300021	Netherlands		PRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
SZ 40/2005	Austria		PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LÖSLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHÄLTNIS 50:50
132006901385692	Italy		PRODUCT NAME: SOSPENSIONE CONTENENTE INSULINA ASPART SOLUBILE E CRISTALLI DI INSULINA ASPART PROTOMINATA NEL RAPPORTO 50/50(NOVOMIX 50); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/00/142/011-012-013-014-015-016, 20051005
99C0044	Belgium		PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
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