RYZODEG 70/30 Drug Profile

Summary for Tradename: RYZODEG 70/30

Patents:	9
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for RYZODEG 70/30
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYZODEG 70/30

Recent Clinical Trials for RYZODEG 70/30

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A
Novo Nordisk A/S

See all RYZODEG 70/30 clinical trials

Recent Litigation for RYZODEG 70/30

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Novo Nordisk Inc. v. Alvogen, Inc.	2022-03-03
NOVO NORDISK INC. v. SANDOZ INC.	2020-06-04
Novo Nordisk Inc. v. Sandoz Inc.	2020-06-03

See all RYZODEG 70/30 litigation

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 RYZODEG 70/30 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for RYZODEG 70/30 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.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2016-06-20	Company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2021-01-05	Company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2023-08-05	Company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2024-10-21	Company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2021-01-05	Company disclosures

3) Low Certainty: US Patents for RYZODEG 70/30 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		2031-10-25	Patent claims search

International Patents for RYZODEG 70/30

Country	Patent Number	Estimated Expiration
Denmark	1909870
Norway	985981
Norway	2018002
Canada	2738877
China	1509193

Supplementary Protection Certificates for RYZODEG 70/30

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
122013000062	Germany		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
92226	Luxembourg		PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
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
92213	Luxembourg		PRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/807/001-4-5-7-8-9-12-13-15 TRESIBA 20130123
138 5015-2013	Slovakia		PRODUCT NAME: INZULIN DEGLUDEK; REGISTRATION NO/DATE: EU/1/12/807/001 - EU/1/12/807/015 20130121