NOVOLOG MIX 70 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 70 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NOVOLOG MIX 70 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 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	5,547,930	2013-09-28	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	5,618,913	2006-08-29	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	5,693,027	2014-09-26	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for NOVOLOG MIX 70 Derived from Patent Text Search

No patents found based on company disclosures

International Patents for NOVOLOG MIX 70

Country	Patent Number	Estimated Expiration
Germany	122006000017
European Patent Office	0499613
Germany	3650101

Supplementary Protection Certificates for NOVOLOG MIX 70

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300021	Netherlands		300021, 20140621, EXPIRES: 20150622
10199011	Germany		PRODUCT NAME: KRISTALLE, ENTHALTEND ASP B28 HUMAN-INSULIN UND PROTAMIN; REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801
SZ 32/2000	Austria		PRODUCT NAME: INSULIN ASPART/PROTAMIN