RYZODEG 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 RYZODEG 70 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for RYZODEG 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.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2034-08-21	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2037-12-14	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2037-11-01	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2037-12-21	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for RYZODEG 70 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.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2039-06-21	Patent claims search
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2033-10-09	Patent claims search
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2032-10-25	Patent claims search

International Patents for RYZODEG 70

Country	Patent Number	Estimated Expiration
Portugal	921812
Australia	2006207744
Hungary	S1300033
South Korea	100451778

Supplementary Protection Certificates for RYZODEG 70

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300596	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
2013/34	Ireland		PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
C201300036	Spain		PRODUCT NAME: INSULINA DEGLUDEC/INSULINA ASPART; NATIONAL AUTHORISATION NUMBER: EU/1/12/806/001, 004, 005, 007, 008; DATE OF AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/806/001, 004, 005, 007, 008; DATE OF FIRST AUTHORISATION IN EEA: 20130121
122013000061	Germany		PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121